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Miya, T., Kobayashi, K., Hino, M., Ando, M., Takeuchi, S., Seike, M., . . . East Japan Chesters Group. (2016). Efficacy of triple antiemetic therapy (palonosetron, dexamethasone, aprepitant) for chemotherapy-induced nausea and vomiting in patients receiving carboplatin-based, moderately emetogenic chemotherapy. Springerplus, 5, 2080-016-3769-x. 

Study Purpose

To assess the efficacy of triple drug antiemetic prophylaxis for patients receiving moderately emetogenic chemotherapy (MEC)

Intervention Characteristics/Basic Study Process

Patients receiving MEC containing carboplatin were treated with standard triple drug antiemetic therapy of palonosetron, dexamethasone, and aprepitant. Patients were assessed from the beginning of chemotherapy to day 7.

Sample Characteristics

  • N = 90   
  • MEDIAN AGE = 69 years
  • AGE RANGE = 38-82 years
  • MALES: 80%, FEMALES: 20%
  • KEY DISEASE CHARACTERISTICS: Not provided
  • OTHER KEY SAMPLE CHARACTERISTICS: All patients were chemotherapy naïve except for patients with lung cancer receiving tyrosine kinase inhibitors.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Not specified    
  • LOCATION: Japan

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Prospective, observational

Measurement Instruments/Methods

  • Functional Living Index-Emesis (FLI-E) questionnaire
  • 100 mm visual analog scale (VAS) for quality of life and nausea severity
  • Common Terminology Criteria for Adverse Events (CTCAE)

Results

No patient vomited within the first 24 hours after chemotherapy. For the delayed and overall phases, completed response was seen in 91.9% of patients. Complete control was seen in 88.9%–97.8% across study days. The lowest rate of complete control was seen on day 3. Men tended to have a high prevalence of complete response and complete control. Hypertension of grade 3, which may have been related to the study drugs, was seen in five patients. Comparison to findings from five other studies showed high complete response rates in the present study.

Conclusions

Triple drug therapy for the prevention of chemotherapy-induced nausea and vomiting (CINV) was shown to be very effective for patients receiving MEC.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Unintended interventions or applicable interventions not described that would influence results
  • No discussion of any use of rescue medication
  • No direct comparison to more standard MEC regimens for antiemesis

Nursing Implications

Triple antiemetic therapy is recommended in several professional guidelines for highly emetogenic chemotherapy but not for MEC. This study showed better efficacy for CINV control compared to some other studies in CINV management for MEC. Triple drug antiemetic prophylaxis should be considered for patients receiving MEC.

Print

Miura, S., Watanabe, S., Sato, K., Makino, M., Kobayashi, O., Miyao, H., . . . Yoshizawa, H. (2013). The efficacy of triplet antiemetic therapy with 0.75 mg of palonosetron for chemotherapy-induced nausea and vomiting in lung cancer patients receiving highly emetogenic chemotherapy. Supportive Care in Cancer, 21(9), 2575–2581. 

Study Purpose

To evaluate the efficacy of triple antiemetic therapy consisting of a 0.75 mg dose of palonosetron, a three-day course of aprepitant, and four days of dexamethasone in the control of chemotherapy-induced nausea and vomiting (CINV) among chemotherapy-naïve patients with lung cancer undergoing highly emetogenic chemotherapy (HEC) regimens

Intervention Characteristics/Basic Study Process

From September 2010 to June 2012, patients received triplet antiemetic therapy (0.75 mg palonosetron IV + 9.9 mg dexamethasone IV + 125 mg of aprepitant orally) on day 1, followed by 80 mg aprepitant on days 2 and 3, and 8 mg dexamethasone on days 2–4.

Sample Characteristics

  • N = 67 (later excluded 4, N = 63)              
  • MEDIAN AGE: 64 years (range = 36–78 years)
  • MALES: 65.7%, FEMALES: 34.3%
  • KEY DISEASE CHARACTERISTICS: Chemotherapy-naïve patients with lung cancer scheduled to receive HEC [50 mg/m2 or higher dose of cisplatin with concurrent agents (pemetrexed [38.8 %], vinorelbine [32.7 %], gemcitabine [9.0 %], irinotecan [7.5 %], etoposide [7.5 %], and docetaxel [4.5 %])
  • OTHER KEY SAMPLE CHARACTERISTICS: No emesis within 24 hours of chemotherapy administration; no symptomatic or suspected brain metastasis; no concomitant radiotherapy; no complications that prohibited dexamethasone use; and no known hypersensitivity to palonosetron, aprepitant, or dexamethasone

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Single-arm, phase II prospective, multi-centered, longitudinal trial

Measurement Instruments/Methods

Assessment started at the observation period and lasted for five days. The patients used a daily questionnaire to record any vomiting episodes, nausea ratings, impairment of eating habits, any use of rescue therapy, and the degree of constipation or diarrhea. The patients assessed their nausea with a 100 mm horizontal Visual Analog Scale (VAS). Scores of 5–100 or 25–100 mm on the VAS scale indicated that patients had experienced insignificant or significant nausea, respectively.
 
Study endpoints included:
  • Overall Complete Response (CR) rate: No vomiting, no use of rescue medication
  • CR rate in the acute phase (0–24 hours)
  • CR rate in the late phase (24–120 hours)
  • Complete Control (CC) rate: No vomiting and no significant nausea without needing rescue medication during the acute, delayed, and overall phases
  • The proportion of patients who experienced no nausea, no significant nausea, and no impairment of eating habits during the acute, delayed, and overall phases
  • Safety

 

Results

The CR rates during the acute and delayed phases were 96.8% and 81.0 %, respectively. Almost half of the patients (54.0%) experienced no nausea (VAS < 5 mm) during the overall and delayed phase. The proportion of patients who experienced no significant nausea (VAS < 25 mm) during the overall, acute, and delayed phases was 66.7%, 93.8%, and 66.7%, respectively. 
  • CR rates: 81% (overall), 96.8% (acute), and 81.0% (delayed)
  • CC rates: 63.5% (overall), 92.1% (acute), and 63.5% (delayed)
  • No nausea: 54% (overall), 84.1% (acute), and 54.0% (delayed)
  • No significant nausea: 66.7% (overall), 93.8% (acute), and 66.7% (delayed)
  • More than half of the patients suffered from appetite loss due to CINV.
  • No of adverse events exceeded grade 3 of the Common Terminology Criteria for Adverse Events (CTCAE). Constipation was the most frequent adverse event.

Conclusions

The triplet antiemetic therapy was the most promising regimen in preventing CINV in chemotherapy-naïve patients with lung cancer treated with HEC. The dose-response relationship between palonosetron and aprepitant use needs to be further investigated. However, the experience of nausea by almost half of the patients during the overall phase highlighted the necessity of conducting further investigations to control CINV during the delayed phase.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement validity/reliability questionable
  • Findings not generalizable
  • No consideration about CINV risk factors such as the explanation not measuring for patients’ history of alcohol consumption; experiencing nausea and vomiting during previous radiotherapy or during pregnancy for female patients; and anxiety level. As the starting of the study was on the first cycle of chemotherapy, the investigators had no chance to determine prior experience of CINV and thus anticipatory nausea and vomiting.

Nursing Implications

Although adding palonosetron to antiemetic regimens shows improvement more impressively in the acute phase among patients, caution should be taken before interpreting the result of this study as it did not use the most robust research design (of randomization, blinding, placebo control) to detect the drug's efficacy. Constipation is a commonly reported adverse effect in this study, therefore careful management should be considered when palonosetron is used.

Print

Mitchell, S., Li, X., Woods, M., Garcia, J., Hebard-Massey, K., Barron, R., & Samuel, M. (2016). Comparative effectiveness of granulocyte colony-stimulating factors to prevent febrile neutropenia and related complications in cancer patients in clinical practice: A systematic review. Journal of Oncology Pharmacy Practice. Advance online publication. 

Purpose

STUDY PURPOSE: To synthesize evidence to compare effectiveness of prophylaxis with a long-acting versus short-acting colony-stimulating factor (CSF)
 
TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED:  MEDLINE, CINAHL, BIOSIS, EMBASE, Cochrane Library, ASCO, ESMO, and MASCC congress databases, and Google Scholar
 
KEYWORDS: Full search terms are provided in a supplemental table
 
INCLUSION CRITERIA: Varied study types, adult patients receiving granulocyte–colony-stimulating factor (G-CSF) prophylaxis, comparative studies of pegfilgrastim versus filgrastim, lenograstim, or short-acting biosimilars, reporting FN and related outcomes
 
EXCLUSION CRITERIA: Randomized controlled trials, children or adolescents, single treatment studies with no comparator

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 1,494
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Large studies used data from pharmacy databases. Four studies were prospective, and the rest were retrospective. The GRADES method was to evaluate studies. Most were of low quality.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 18; 3 were conference abstracts 
  • TOTAL PATIENTS INCLUDED IN REVIEW = 22,882
  • SAMPLE RANGE ACROSS STUDIES: 20–32,072
  • KEY SAMPLE CHARACTERISTICS: Multiple tumor types

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Results

Febrile neutropenia (FN) and FN-associated hospitalization: In seven studies comparing pegfilgrastim with short-acting CSF, the risk of FN was significantly lower in three studies, and numerically lower in three studies for those on pegfilgrastim. Those receiving pegfilgrastim had a lower risk of FN-related hospitalization. Duration of short-acting CSF use varied. Fewer FN-related deaths, severe neutropenia episodes, dose reductions, and antimicrobial use were seen with pegfilgrastim.

Conclusions

Findings suggest that the use of long-acting CSFs was associated with a lower risk of FN, FN hospitalizations, and other related adverse patient outcomes.

Limitations

  • Tumor types varied. Those with hematologic cancers were included, but there was no subgroup analysis to differentiate from those with lower-risk solid tumor types.
  • Variability of chemotherapy regimens involved
  • Variation in the timing and duration of short-acting CSF interventions and dose differences that were not captured in the data
  • Known potential inaccuracies of medical claims data from which most cases were obtained
  • There is no single diagnosis code for FN, and the algorithms used to define FN can vary.
  • Low GRADES quality rating of studies included.
  • Some data was provided per patient, and some was provided per cycle.
  • In some studies, patients had received both filgrastim and pegfilgrastim.

Nursing Implications

Findings suggest that use of long-acting CSF may provide better prophylaxis for FN and FN-related events, but data and limitations of this review were insufficient to draw firm conclusions. Because of the variety of new biosimilar alternatives, additional work to determine comparative effectiveness and cost-benefit analysis of various formulations is increasingly important. This study does raise the question of what denominator is best used in outcomes measurement, whether outcomes should be viewed per patient, per cycle, or per patient-cycle.

Print

Mitchell, G.K., Hardy, J.R., Nikles, C.J., Carmont, S.A., Senior, H.E., Schluter, P.J., . . . Currow, D.C. (2015). The effect of methylphenidate on fatigue in advanced cancer: An aggregated N-of-1 trial. Journal of Pain and Symptom Management, 50, 289–296. 

Study Purpose

To determine the efficacy of alleviating fatigue using the psychostimulant methylphenidate hydrochloride (MPH) in patients with advanced cancer

Intervention Characteristics/Basic Study Process

MPH 5 mg was taken orally twice daily versus placebo for three cycles of a pair of three-day periods. Patients completed a daily diary of symptom scales and side effects.

Sample Characteristics

  • N = 24  
  • MEDIAN AGE = 71 years
  • MALES: 54%, FEMALES: 46%
  • KEY DISEASE CHARACTERISTICS: Gastrointestinal, prostate, lung, breast, and genitourinary cance
  • OTHER KEY SAMPLE CHARACTERISTICS: ​Australia-modified Karnofsky Performance Scale (AKPS) ≥ 40; screening fatigue score ≥ 4/10 (National Comprehensive Cancer Network); stable treatment regimen for at least 48 hours; no plan for treatment likely to influence fatigue; no change in thyroxine, antidepressant therapy, or other drugs with sympathomimetic potential for three weeks prior to recruitment

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Not specified    
  • LOCATION: Queensland and New South Wales, Australia

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS: Palliative care

Study Design

Population was estimated using the aggregated N of one multicycle, double-blinded, controlled, crossover study.

Measurement Instruments/Methods

  • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
  • Wu Cancer Fatigue Scale (WCFS)
  • Edinburgh Depression Scale (EDS)
  • AKPS performance scale

Results

Eight patients had individual improvements in fatigue with MPH compared to a placebo on the FACIT-F and WCFS scores, but the mean population estimate showed no important difference. Seven patients showed an improvement in EDS scores, but the mean population estimate showed no important difference. There was no change in AKPS scores. There were six adverse events with three events possibly related to MPH.

Conclusions

Although there may be some individual improvement in fatigue with MPH use, the results of this small sample size were difficult to generalize.

Limitations

  • Small sample (< 30)
  • Selective outcomes reporting
  • Measurement validity/reliability questionable
  • Subject withdrawals ≥ 10%  
  • Other limitations/explanation: Patients self-reported; N of one design; intention to treat analysis used a combination of weighted group estimates and prior values for missing data; of 43 patients originally recruited, only 55.8% completed three cycles of treatment; the mean population response estimate also included patients who did not complete any study cycle, so it is unclear if results are over or underestimated; study cycle times were short and may not have allowed for full drug effects

Nursing Implications

Continued studies on the effects of psychostimulants on cancer-related fatigue are needed. This study adds to the growing body of evidence that methylphenidate is not generally helpful in reducing fatigue. The strength of this study's results are limited by design issues.

Print

Mitchell, G.K., Girgis, A., Jiwa, M., Sibbritt, D., Burridge, L.H., & Senior, H.E. (2013). Providing general practice needs-based care for carers of people with advanced cancer: A randomised controlled trial. The British Journal of General Practice, 63(615), e683–e690.

Study Purpose

To test whether a general practice consultation directed by a carer needs checklist would improve meeting the needs of carers

Intervention Characteristics/Basic Study Process

General practitioners of intervention patients were visited, introduced to intervention resources, and invited to participate. Tools provided were a needs assessment tool and a general practice toolkit of paper-based and electronic forms providing evidence-based information, resources, and services that might help address problems. Consultations were provided at baseline and at three months, based on needs assessment results. Patients were randomized, but those whose general practitioner had a previous participant were nonrandomly allocated to the same study group to prevent contamination. Data collection included survey at one, three, and six months by telephone interview. Control group general practitioners were not contacted. General practitioners were educated on the process through academic detailing.

Sample Characteristics

  • N = 211 carers
  • MEAN AGE = 57.5 years
  • MALES: 33.5%, FEMALES: 66.5%
  • KEY DISEASE CHARACTERISTICS: Varied prognoses in terms of life expectancy 
  • OTHER KEY SAMPLE CHARACTERISTICS: Most carers were spouse or partner and lived with the patient. 32% were employed full-time, and 18.5% were employed part-time. 

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Australia

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late effects and survivorship
  • APPLICATIONS: Palliative care 

Study Design

  • Single-blind RCT

Measurement Instruments/Methods

  • Supportive care needs survey for partners and carers to measure unmet needs
  • Hospital Anxiety and Depression Scale
  • SF-12

Results

Twenty-nine percent of intervention group patients and 15% of control group patients dropped out of the study—most said this was because they were too busy to continue after their initial interview. Three of 158 general practitioners refused to conduct the consultations. No between-group differences were seen in change from scores at baseline to scores at any time point. Subgroup analysis showed no change in depression scores. For those who were clinically depressed at baseline, control patients demonstrated significantly worse anxiety at six months, while intervention group scores were essentially stable. Intervention group carers with baseline anxiety or depression reported deterioration in physical scores on the SF-12 (p = .053). In analysis adjusted for baseline anxiety, those in the intervention group had significant worsening of physical function scores (p = .037) and increased psychological and emotional needs from baseline to three months (p = .033). Those caring for less ill individuals had improvement in mental health at three months in SF-12 scores.

Conclusions

The study did not demonstrate improvement in intensity or number of unmet needs or carer outcomes overall.

Limitations

  • Risk of bias (no random assignment) 
  • Risk of bias (no appropriate attentional control condition)  
  • Unintended interventions or applicable interventions not described that would influence results
  • Questionable protocol fidelity 
  • Subject withdrawals 10% or greater 
  • Other limitations/explanation: Although general practitioner participation was stated, actual completion of expected consultations at the expected timeframes is not discussed or reported—no approach to ensure treatment fidelity in such consultations; high attrition rate; no information about the patient’s type of cancer, severity, or symptoms is provided—these are likely to have an impact on the degree of caregiver burden and associated outcomes; the nature of the general practice consultation is not clearly described, and actions taken to meet assessed needs is not discussed.
 

 

Nursing Implications

Findings did not support the idea of reducing carer unmet needs via an assessment-driven general practice consultation over time. Undergoing assessment of needs possibly increases the degree to which carers identify needs that are not being met. This study focused on provision of tools to general practitioners but does not describe what actions were taken on the basis of the assessment done, so it provides little support for any specific approach to address caregiver needs.

Print

Misra, S., Parthasarathi, G., & Vilanilam, G.C. (2013). The effect of gabapentin premedication on postoperative nausea, vomiting, and pain in patients on preoperative dexamethasone undergoing craniotomy for intracranial tumors. Journal of Neurosurgical Anesthesiology, 25, 386–391.

Study Purpose

To determine if prophylactically administered 600 mg oral gabapentin reduces postoperative nausea or emesis and decreases postcraniotomy pain

Intervention Characteristics/Basic Study Process

Patients to undergo elective craniotomy were randomized to receive either placebo (a vitamin b-complex capsule) or 600 mg oral gabapentin two hours before induction of anesthesia. All received standard antiepileptic prophylaxis with 100 mg phenytoin every eight hours and 4 mg IV dexamethasone every eight hours for 48 hours prior to surgery. Patients were given 1 gm IV paracetamol every six hours for postoperative pain. Rescue analgesia was provided with 1 mcg/kg IV fentanyl for a pain score of 3. Rescue antiemetic was provided with 4 mg IV ondansetron if the patient had any emetic episode or 10 minutes or longer of nausea. All received the same anesthesia. Symptoms were assessed hourly for the first six hours postoperatively and then every two hours for the next 18 hours.

Sample Characteristics

  • N = 73  
  • MEAN AGE = 44 years
  • MALES: 68.5%, FEMALES: 31.5%
  • KEY DISEASE CHARACTERISTICS: All were undergoing craniotomy
  • OTHER KEY SAMPLE CHARACTERISTICS: Duration of anesthesia averaged slightly more than 400 minutes and was not different between study groups.

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient   
  • LOCATION: India

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Placebo-controlled RCT

Measurement Instruments/Methods

  • Pain verbal rating scale of 0 (no pain) to 3 (moderate to severe, requiring rescue)

Results

Incidence of nausea was 35.1% in the placebo group compared to 11.1% in the gabapentin group (p = .02). No significant difference was seen between groups in incidence of emesis, but there was a trend to lower incidence of emesis with gabapentin. No difference was seen between groups in postoperative pain scores, the number of patients who required rescue analgesia, or postoperative fentanyl consumption.

Conclusions

Prophylactic oral gabapentin prior to surgery reduced postoperative nausea and vomiting in patients undergoing craniotomy. Perioperative gabapentin had no effect on postoperative pain.

Limitations

  • Small sample (less than 100)
  • Risk of bias (no blinding)
  • Measurement validity/reliability questionable
  • The method of pain measurement is questionable, as a 3-point scale.

Nursing Implications

Preoperative gabapentin may reduce postoperative symptoms of nausea and vomiting in patients undergoing craniotomy who are receiving dexamethasone perioperatively. The optimum dosage of gabapentin has not been determined.

Print

Mishra, S., Bhatnagar, S., Goyal, G.N., Rana, S.P., & Upadhya, S.P. (2012). A comparative efficacy of amitriptyline, gabapentin, and pregabalin in neuropathic cancer pain: A prospective randomized double-blind placebo-controlled study. American Journal of Hospice and Palliative Care, 29, 177–182.

Study Purpose

To compare the efficacy of amitryptylline, gabapentin, and pregabalin in patients with cancer experiencing neuropathic pain

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to amitryptyllin (AT), gabapentin (GB), pregabalin (PG), or placebo. AT was given at 50 mg/day for one week, then increased incrementally to 100 mg/day. GB was given at 900 mg/day for one week in divided doses, then increased to 1,800 mg/day by week 3. PG was given at 150 mg/day for one week, then increased to 600 mg/day by week 3. The control group received placebo capsules. Morphine was used as rescue pain medication as needed. Patients were evaluated weekly for four weeks.

Sample Characteristics

  • The study reported on 120 patients.
  • Information on patient age and key disease characteristics was not provided.

Setting

  • Single site    
  • Setting not specified
  • India

Phase of Care and Clinical Applications

The study has clinical applicability for late effects and survivorship.

Study Design

The study was a placebo-controlled, randomized trial.

Measurement Instruments/Methods

  • Visual analog scale (VAS) to measure pain globally as well as burning, lancinating pain and dysesthesia
  • Eastern Cooperative Oncology Group (ECOG) score for functional capacity
  • Global satisfaction rating on a five-point verbal scale

Results

VAS scores decreased in all groups. In week 4, those on pregabalin had significantly lower VAS scores than other groups, and scores declined by 4–5 points (p < 0.03). By the third visit, the percentage of patients who required morphine rescue increased: 46.7% with AT, 23.3% with GB, 16.7% with PG, and 100% with placebo. Lancinating pain incidence was lowest in the PG group. There were significantly fewer patients with dysesthesia in the PG group (6.7%) compared to the GB and placebo groups after four weeks. The percentage of patients with allodynia declined in all groups. The PG group showed a statistically significant improvement in ECOG score compared to all other groups (p < 0.001). Satisfaction was similar in all groups, and there were no significant differences in adverse reactions, with a gradual increase in all groups over time. Adverse effects were somnolence, dizziness, nausea, constipation, and dry mouth.

Conclusions

All of the drugs tested here demonstrated some efficacy in improving neuropathic symptoms. In several areas, it appears that pregabalin was more effective than gabapentin, opioid monotherapy, and amitryptylline. All medications were given in combination with opioids for pain management.

Limitations

  • No information of opioid dosages in each group was provided for comparison.
  • The follow-up period of four weeks was relatively short, given the usual duration of symptoms.
  • No information was provided regarding the causes of peripheral symptoms (whether they were chemotherapy-induced or related to other causes).

Nursing Implications

All of the medications examined in this study were effective and had a morphine-sparing effect in the treatment of neuropathic pain and other symptoms. Pregabalin was more effective than other alternatives tested in some areas. As all patients in this study received opioids for pain rescue, it should be noted that essentially all medications compared were given in combination with opioids.

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Mishra, S., Bhatnagar, S., Rana, S.P., Khurana, D., & Thulkar, S. (2013). Efficacy of the anterior ultrasound-guided superior hypogastric plexus neurolysis in pelvic cancer pain in advanced gynecological cancer patients. Pain Medicine, 14, 837–842.

Study Purpose

To evaluate the effect of anterior ultrasound-guided superior hypogastric plexus neurolysis in patients with gynecologic cancer with pelvic cancer pain

Intervention Characteristics/Basic Study Process

Patients were randomly divided into two groups. Group 1 received oral morphine for pain control, and group 2 had ultrasonography-guided superior hypogastric plexus neurolysis (SHPN). Oral morphine was given to both groups as rescue analgesia. The pain, functional capacity, global satisfaction score, and adverse effects were recorded.

Sample Characteristics

  • N = 50  
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Advanced gynecologic malignancy (stage III and IV), no planned curative intervention or chronic pelvic pain, visual analog scale (VAS) score greater than 7
  • EXCLUSION CRITERIA: Unstable cardiovascular, respiratory, hepatic, or hematologic disease; psychological disorder; lower limb neurologic disorder; drug abuse

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient   
  • LOCATION: Rotary Cancer Hospital, New Delhi, India

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Elder care, palliative care

Study Design

  • Randomized, controlled trial

Measurement Instruments/Methods

  • VAS
  • Eastern Cooperative Oncology Group (ECOG) status
  • Global pain relief score
  • Global satisfaction score

Results

No difference was seen between the two groups when comparing age, height, and wight (P > 0.05). Both groups showed a significant decrease in VAS pain sores at one week, one month, two months, and three months, and from baseline at each visit (P < 0.05). At three months, no significant difference was seen in VAS scores. No statistical difference was seen in baseline morphine consumption. Consumption declined from baseline in group 2 at the first week, but consumption increased at the rest of the time points. At the first week and month, rescue doses of morphine differed but not significantly for the last two visits. At week one, ECOG status was significantly better for group 2 (p = 0.002), and global pain was better at one month (p = 0.008), but by the end of the study, no statistical difference was seen. The global satisfaction score was better at dthe first week (p = 0.00) and first month (p = 0.04). Less adverse effects occurred in group 2 than group 1, but the difference was not statistically significant.

Conclusions

Ultrasonography-guided SHPN may be a potential intervention for patients with gynecologic cancer experiencing pelvic pain. This may be an option for those who cannot tolerate opioids or are experiencing adverse effects from long-term use of opioids. Although this intervention requires prep and fasting and is associated with its own adverse effects and risk, this may be an option for intervention. This study does not appear strong enough to replace opiate as the standard but rather supports the intervention as an adjuvant treatment because a portion of patients with cancer may be resistant to traditional therapies.

Limitations

  • Small sample (less than 100)
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Findings not generalizable
  • Other limitations/explanation: The intervention requires a certain amount of expertise to perform, can be associated with several adverse effects, is invasive, and requires bowel prep and the patient to fast for eight hours.

Nursing Implications

Nurses need to be aware of this potential intervention and management of adverse events in practice. Education would be required to manage adverse effects and side effects of this intervention.

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Mishra, S.I., Scherer, R.W., Geigle, P.M., Berlanstein, D.R., Topaloglu, O., Gotay, C.C., & Snyder, C. (2012). Exercise interventions on health-related quality of life for cancer survivors. Cochrane Database of Systematic Reviews, 8, CD007566.

Purpose

To conduct a meta-analysis of the effectiveness of exercise interventions on health-related quality of life (HRQoL) and domains (e.g., physical, psychological, economic, social, and spiritual well-being) of HRQoL among adult cancer survivors posttreatment.

Search Strategy

Databases searched were Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, MEDLINE, EMBASE, CINAHL, PsycINFO, PEDro, LILACS, SIGLE, SPORTDiscus, OTSeeker, Sociological Abstracts, Web of Science, and Scopus.

Search keywords (selected from appendices) were exercise, quality of life, health-related quality of life, pain, and cancer.

Studies were included in the review if they

  • Were randomized, controlled trials (RCTs) and controlled clinical trials that compared exercise interventions with either usual care or no exercise
  • Evaluated the impact on overall HRQoL or at least one domain of HRQoL in cancer survivors posttreatment
  • Reported cancer survivors diagnosed as adults (18 years and older).

Studies were excluded if they reported patients with terminal cancer or in hospice care who were receiving active treatment for primary or recurrent cancer.

Literature Evaluated

A total of 1,795 relevant references were retrieved.  A total of 1,636 articles were excluded based on the title and abstract.  After further review of the abstract, 82 were excluded because they did not meet the inclusion criteria. An additional 13 were excluded from qualitative synthesis because they were ongoing studies.

Sample Characteristics

  • The review included a final number of 40 trials in qualitative synthesis and 33 in quantitative (meta-analysis of findings).
  • A total of 3,694 participants were randomized to an exercise (n = 1,927) or control (n = 1,764) group.
  • Of the 40 studies, 38 were RCTs, three used variation of an RCT, and two used a quasiexperimental design. All but four trials were randomized to an exercise group or a control group.
  • Studies included various cancer types, including breast, colorectal, head and neck, and others. Twenty-two trials were focused on breast cancer only.
  • The time frame included 30 studies completed with treatment and 10 completed during and after cancer treatment. Only posttreatment data were included. The range of treatment time was immediate completion of treatment to up to 15 years after completion.
  • The majority of trials reported females only; 15 used mixed gender samples.
  • Participant age ranged from 39 to 68 years.
  • Of those reporting socioeconomic status, the majority of participants had at least a high school education.
  • Fifteen trials reported past exercise use, with types of exercise including strength and resistance training, walking, cycling, yoga, qigong, and tai chi.

Phase of Care and Clinical Applications

The review has clinical applicability for late effects and survivorship.

Results

Exercise had a positive effect on change in HRQoL scores at 12 weeks and six months of evaluation, and it improved cancer-specific HRQoL in breast cancer concerns. The effect on HRQoL remained after exclusion of patients who were receiving active treatment. For cancer-specific HRQoL, there was significant improvement in exercise groups compared with controls for breast cancer concerns at baseline to 12 weeks and six months. There was a significant decrease in anxiety in the exercise group compared to controls at 12 weeks only (standardized mean difference [SMD] = -0.26; 95% confidence interval [CI] [-0.44, -0.07]) but not in breast cancer-only analysis. There was a high risk of bias in most of these studies, and when these were removed, the results were not significant. Significant differences were noted in body image at follow-up (12 weeks to six months and beyond) using the Rosenberg Self-Esteem Scale. Significant change scores were noted for cancers other than breast for improving depression scores (SMD = -0.46; 95% CI [-0.72, -0.19]). Significant improvements were noted in emotional well being (12 weeks) and fatigue (12 weeks and 6 months) (SMD = -0.42; 95% CI [-0.83, -0.02]). No effects after six months were seen for fatigue, and effects were not significant when studies involving patients during treatment were excluded. Improvement in pain using follow-up scores (12 weeks) was seen (SMD = -0.29; 95% CI [-0.55, -0.04]), but this was from a single trial. Positive effects were noted in sexuality scores at six months and sleep disturbance at 12 weeks (sleep SMD = -0.46; 95% CI [-0.72, -0.20]). Significant improvements were noted in change scores for social functioning (12 weeks and six months). No significant changes were noted in cognitive function, general health perspective, role function, and spirituality in exercise trials.

Conclusions

Exercise interventions showed beneficial effects on HRQoL and some HRQoL domains, including breast cancer concerns, body image, emotional well being, sexuality, sleep disturbances, social functioning, anxiety, fatigue, and pain at various follow-up time points.

Limitations

  • Studies included used exercise programs of various types, intensity levels, and lengths.
  • Significant effects found tended to be in subgroups of patients or at only one time point, limiting the confidence in observed effects.
  • Measures of HRQoL varied, creating heterogeneity among the studies in how HRQoL was quantified.
  • There was a high risk of bias in the trials reviewed. In many cases, no significant effects were seen when analyzing changes in symptoms from baseline to follow-up time points, and significant findings were seen in comparing only follow-up scores between various comparison groups. Results should be used with caution for these reasons.

Nursing Implications

Findings supported the general benefit of exercise for patients with cancer; however, there is further need for research to verify the positive effects of exercise on symptoms of cancer in various patient groups and at various phases of cancer care. These future research studies should determine how to produce larger effect sizes over time and delineate predictors of that effect, such as type of exercise, intensity of the program, timing, and type of cancer and treatment in order to maximize the effect on QoL. It will be important to note that certain questionnaires can affect the outcomes, and consistency would improve this body of research.

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Mishra, S.I., Scherer, R.W., Snyder, C., Geigle, P., & Gotay, C. (2014). Are exercise programs effective for improving health-related quality of life among cancer survivors? A systematic review and meta-analysis. Oncology Nursing Forum, 41, E326–E342. 

Purpose

PURPOSE: To evaluate the effectiveness of exercise interventions on several domains of health-related quality of life

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: MEDLINE, CENTRAL, EMBASE, CINAHL, psycINFO, PEDRO, LILACS SIGLE, SportDiscus, OTSeeker, and Sociological Abstracts from inception to October 2011
 
KEYWORDS: Not provided
 
INCLUSION CRITERIA: Randomized, controlled trials or controlled trials; adult cancer survivors; compared exercise interventions to usual care or another nonxercise intervention
 
EXCLUSION CRITERIA: Patients in hospice; terminally ill patients; patients receiving active treatment

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 1,795
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Cochrane handbook method for risk of bias assessment

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 40 in systematic review (33 in meta-analysis)
  • TOTAL PATIENTS INCLUDED IN REVIEW = 3,694
  • SAMPLE RANGE ACROSS STUDIES: 7–271 patients
  • KEY SAMPLE CHARACTERISTICS: Multiple tumor types

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship

Results

Studies included those with interventions such as yoga, tai chi, and qigong, as well as more traditional exercises. Moderate to vigorous exercise was associated with positive effects on quality of life (SMD = 0.29, 95% CI = 0, 0.58), but no effect was seen for mild to moderate level exercise. These findings did not differ by type of cancer. Anxiety was reduced in all studies by 12 weeks, but this was not observed at longer follow-up periods. At 12 weeks, more vigorous exercise showed no overall effect on anxiety with pooled data. However, a significant effect was seen with mild to moderate exercise (SMD = -0.26, 95% CI = -0.02,-0.51). For fatigue, there were significant positive effects at 12 weeks and between three and six months, but not at six months

Conclusions

The findings of this review show the benefits of various types of exercise on anxiety, fatigue, and quality of life among cancer survivors. Results varied by exercise intensity and at various time points in patient follow-up. This suggests that benefits exist mainly in the short-term up to six months.

Limitations

Most studies showed a moderate to high risk of bias. All types of exercise were combined with various mind/body interventions, which would affect the results of the meta-analysis. It is not clear that these various types of interventions are truly equivalent types of interventions. The methods of measurement for the studies included were not provided, and differences in measurement would affect the meta-analysis. The search result volumes differed in two areas of this report. The differences reported by exercise intensity are confusing. It is not clear how more vigorous exercise improved quality of life while less vigorous exercise only affected anxiety.

Nursing Implications

Overall findings confirm other findings that exercise is beneficial for patients with cancer at various phases of care. This particular analysis was aimed at cancer survivors who completed initial treatment. It is of interest that the benefits of interventions appear to wane around the six-month timeframe. It is not clear if the interventions were done in a group setting for some time period or if social interaction could have influenced the findings that long-term effects were not generally seen if group exercise activity had ceased. Future research in this area should incorporate data to facilitate our understanding of the longevity of effects and mechanisms to maintain improvements long-term.

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