Skip to main content

Mirabile, A., Celio, L., Magni, M., Bonizzoni, E., Gianni, A.M., & Di Nicola, M. (2014). Evaluation of an every-other-day palonosetron schedule to control emesis in multiple-day high-dose chemotherapy. Future Oncology, 10, 2569–2578.

Study Purpose

To determine the proportion of patients achieving complete control during the overall study period and continued for 24 hours after the last dose of chemotherapy, and to determine the proportion of patients achieving complete control within each 24-hour interval of observation

Intervention Characteristics/Basic Study Process

The first 50 patients received ondansetron plus dexamethasone. The experimental group received 0.25 mg IV palonosetron 30 minutes prior to chemotherapy on day 1, then every other day for the duration of the high-dose chemotherapy. Patients also received daily dexamethasone and omeprazole. The rescue medication was metoclopramide for any emesis or if the patient requested the medication. Nurses obtained data from the patients, including subjective nausea assessment every 24 hours and any episodes of emesis or use of rescue medication. Chemotherapy regimens included several myeloablative and non-myeloablative regimens.

Sample Characteristics

  • N = 108   
  • AGE = 20–76
  • MALES: 67%, FEMALES: 33% 
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Non-Hodgkin lymphoma, Hodgkin disease, breast cancer, testicular cancer, sarcoma
  • OTHER KEY SAMPLE CHARACTERISTICS: Alcohol consumption, chemotherapy type (melphalan versus cytarabine versus other regimens)

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Milan, Italy

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Exact single-stage design using a historical cohort

Measurement Instruments/Methods

Nausea in the past 24 hours was measured using a subjective Likert-type scale ranging from 1–4. Emesis was measured by nurses. Use of rescue medication was measured from nurse reports. Patients who withdrew from the study were considered nonresponders. Patient age, gender, alcohol consumption, emetic regimen, and duration of chemotherapy were evaluated as predictive of chemotherapy-induced nausea and vomiting (CINV). Odds ratios, Fisher’s exact test, a chi-squared test, and the Mann-Whitney U test were used.

Results

The average number of days of chemotherapy was 4.7 with a range of 2–6 days in the historical cohort and 4.3 days with a range of 2–6 days in the palonosetron group. Complete control was 50% for overall, 58% for early, and 82% for the historical group. In the palonosetron group, the complete control was 81%, 84.5%, and 96.5%. Overall difference for the overall study period showed a p value of 0.001. The early period showed a p value of 0.002, and the p value of the late period was 0.022. In both cohorts, patients without nausea or with mild nausea did not experience emesis. Patients with emesis were significantly more prevalent in the ondansetron arm (p < 0.005).

Conclusions

The change to every other day palonosetron significantly improved the management of CINV in multiday high-dose chemotherapy.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)

 

Nursing Implications

Evidence supports every other day palonosetron, which is safe and effective for managing CINV in high-dose chemotherapy that is given over several days.

Print

Mirabile, A., Airoldi, M., Ripamonti, C., Bolner, A., Murphy, B., Russi, E., . . . Bossi, P. (2016). Pain management in head and neck cancer patients undergoing chemo-radiotherapy: Clinical practical recommendations. Critical Reviews in Oncology/Hematology, 99, 100–106. 

Purpose & Patient Population

PURPOSE: To provide consensus recommendations for pain management in the setting of patients with head and neck cancer-induced oral mucositis
 
TYPES OF PATIENTS ADDRESSED: Patients with head and neck cancer undergoing chemotherapy and/or radiation therapy

Type of Resource/Evidence-Based Process

RESOURCE TYPE: Evidence-based guideline

PROCESS OF DEVELOPMENT: 37 experts met and appointed a four-person facilitator board who formed a systematic review of literature on pain in patients with head and neck cancer undergoing chemo-radiation treatment. On the basis of the systematic review, facilitators drafted key statements. These were provided to panel members and rated using a Delphi appropriateness method. After panel discussion and final statements reaching consensus, external specialists in medical oncology and supportive cancer care reviewed the statements.
 
DATABASES USED: MEDLINE
 
INCLUSION CRITERIA: Any study design; consensus guideline; abstracts presented at annual meetings of the American Society of Clinical Oncology (ASCO) and of the European Society of Medical Oncology (ESMO)

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment
 
APPLICATIONS: Palliative care 

Results Provided in the Reference

  • Not reported

Guidelines & Recommendations

The consensus document provides overall statements regarding the importance of pain management, assessment for pain, and the need to have patients continue swallowing efforts to minimize atrophy and fibrosis. Specific recommendations regarding pain-related interventions are:
  • Basic oral care will reduce severity of oral mucositis and associated pain.
  • An opioid-based systemic pain control program is usually needed.
  • Topical coating agents and anesthetics may reduce mucosal sensitivity, but with short duration.
  • Topical capsaicin should not be used.
  • A transmucosal opioid is a rational approach to odynophagia, which should be viewed as incidental breakthrough pain.

Limitations

No quality rating of evidence used is discussed, and numerous consensus statements are not supported by evidence or any references.

Nursing Implications

This guideline is a mix of consensus-based and evidence-based recommendations. Nurses should be aware of the need for patients to continue trying to swallow to avoid disuse muscle atrophy and fibrosis from treatment. This guideline suggests that pain on swallowing be managed as breakthrough pain, and that transmucosal opioids would be an appropriate approach for management.

Print

Miotto, E.C., Savage, C.R., Evans, J.J., Wilson, B.A., Martin, M.G., Balardin, J.B., . . . & Amaro Junior, E. (2013). Semantic strategy training increases memory performance and brain activity in patients with prefrontal cortex lesions. Clinical Neurology and Neurosurgery, 115, 309-316.

Study Purpose

To investigate the neural correlates of semantic strategic training in patients with distinct prefrontal cortex lesions

Intervention Characteristics/Basic Study Process

In the 30-minute semantic organizational strategy training, subjects were taught three steps to improve memory: (1) organize words into categories, (2) memorize words, and (3) retrieve words by category. Subjects were required to undergo a minimum of five training trials and to demonstrate that they had learned how to apply the semantic organizational strategy. Pre- and post-test evaluations consisted of subjects undergoing functional magnetic resonance imaging (fMRI) scanning immediately prior to and after the semantic strategy training.

Sample Characteristics

  • N = 21      
  • MEAN AGE = 45.7 years for bilateral orbitofrontal cortex (BOFC) patients and 39.57 years for dorsolateral prefrontal cortex (LPFC) patients
  • MALES: 57%, FEMALES: 43%
  • KEY DISEASE CHARACTERISTICS: 21 patients with confirmed primary brain tumor (PBT) located in the prefrontal cortex, specifically the LPFC or BOFC
  • OTHER KEY SAMPLE CHARACTERISTICS: At least six months post-chemotherapy and radiation therapy; time since surgical resection ranged from 6 months to 10 years (mean = 2.65 years; SD = 2.4 years); all subjects were non-aphasic, right-handed, and free of other neurological or psychiatric conditions.

Setting

  • SITE: Not stated/unknown  
  • SETTING TYPE: Not specified    
  • LOCATION: Not stated but ethics approval was received from the University of Sao Paulo Medical School.

Study Design

Exploratory study using a pre- and post-test design in a convenience sample

Measurement Instruments/Methods

  • 3 word lists of 16 words each: unrelated and related non-structures, and related structure word lists for cortical activation during scanning
  • fMRI scan

Results

Both subject groups recalled more words (p < 0.001) and organized more words together (p < 0.001) after semantic training. For the BOFC group, there were significant differences (p < 0.01) after the intervention of increased activation: (1) right cuneus and posterior cingulate gyrus, and left precuneus during the related structure word list trial and (2) left precentral gyrus, postcentral gyrus, inferior frontal gyrus, and insula during the unrelated word list trial. For the LPFC group, there were significant differences (p < 0.01) after the intervention, in multiple cortical areas: (1) increased activation in the left inferior frontal gyrus, precentral gyrus, and insula during the related non-structured word list trial (2) increased activation in the left inferior frontal gyrus, precentral gyrus, and anterior cingulate during the related structure word list trial, and (3) decreased activation in the left supramarginal gyrus, precuneus, superior temporal gyrus, and superior parietal lobe during the related structure word list.

Conclusions

The intervention increased use of categorizing words, thereby improving memory performance in subjects with prefrontal PBT. Changes in cortical activation suggest intervention application and recruitment of compensatory brain mechanisms for memory tasks. Further study with longitudinal measures is warranted to demonstrate continued cortical activation and intervention application during memory tasks.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Findings not generalizable
  • Intervention expensive, impractical, or training needs
  • Other limitations/explanation: fMRI scanning for pre- and post-measures is expensive, is impractical, and requires specialized training and equipment. This study was performed in a homogenous sample.

Nursing Implications

This study demonstrated the application of a quick single session semantic training intervention aimed at improving verbal memory performance in those with known neuropathology.

Print

Minuk, L.A., Monkman, K., Chin-Yee, I.H., Lazo-Langner, A., Bhagirath, V., Chin-Yee, B.H., & Mangel, J.E. (2012). Treatment of Hodgkin lymphoma with adriamycin, bleomycin, vinblastine and dacarbazine without routine granulocyte-colony stimulating factor support does not increase the risk of febrile neutropenia: A prospective cohort study. Leukemia and Lymphoma, 53, 57–63.

Study Purpose

The purpose of the study was to evaluate a protocol change of not routinely prescribing G-CSF to manage uncomplicated neutropenia in patients with Hodgkin lymphoma on adriamycin, bleomycin, vinblastine, and dacarbazine (ABVD) therapy.

Intervention Characteristics/Basic Study Process

Eligible patients who consented to participate had baseline data collected (demographics, comorbidities, standard blood tests, routing staging via computed tomography scan, and bone marrow biopsies when indicated, and prognostic factors). Response rates were evaluated via repeat computed tomography scans following completion of ABVD therapy. Patients with limited stage disease received 2–4 cycles of ABVD with involved field radiation and those with advanced stage disease received 6–8 cycles of ABVD. Blood tests were taken every two weeks. No primary prophylactic G-CSF was administered; but was given as secondary prophylactic for febrile neutropenia. Adjustments were made to the chemotherapy regimen for nonhematologic toxicities (peripheral neuropathy or lung toxicity). Comparisons were made to a retrospective chart review in which C-GSF was administered as primary prophylaxis.

Sample Characteristics

  • 33 in the prospective group, 89 in the retrospective study group
  • Mean age was 38 years in the prospective group and 42 years in the retrospective group.
  • 18 males (55%) were in the prospective group and 50 (56%) were in the retrospective group. 15 females (45%) were in the prospective group and 39 (46%) were in the retrospective group
  • Key disease characteristics include biopsy-proven Hodgkin lymphoma
  • Participants were excluded if neutropenic or if they had significant cytopenias prior to starting chemotherapy, Hodgkin lymphoma-related bone marrow involvement, initiating chemotherapy as an inpatient, and/or comorbidities of HIV, active infection, or severe cardiac or pulmonary disease

Setting

A single-site outpatient location (the London Regional Cancer Program)

Phase of Care and Clinical Applications

Active antitumor treatment

Study Design

Prospective cohort with comparison to historical cohort

Measurement Instruments/Methods

  • Statistical analyses included using two-tailed Mann-Whitney U test for continuous variable comparisons with chi-square or Fisher’s exact test for proportional comparisons.
  • Taylor series approximation was used to calculate the absolute difference in risk of developing febrile neutropenia.
  • Cost analysis was also conducted.

Results

Six percent of patients in the prospective group (did not receive primary prophylactic G-CSF) acquired febrile neutropenia, interfering with 0.6% of chemotherapy treatments. There was no significant difference from the retrospective comparison group in rate of febrile neutropenia, although the prospective group had a significantly higher rate of neutropenia (p < 0.001). The cost savings to the institution of not using primary prophylactic G-CSF was $10,241.

Conclusions

Not using G-CSF as a primary prophylactic treatment for patients with uncomplicated neutropenia who are being treated with ABVD for Hodgkin lymphoma is safe and cost saving.

Limitations

  • Small sample (less than 100 participants)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)

 

Nursing Implications

Closely monitoring patients for febrile neutropenia would be highly important in patients not receiving G-CSF as primary prophylaxis. Educating patients and healthcare providers about the safety of not using G-CSF as a primary prophylactic treatment is important. While this study provides some evidence that primary prophylaxis may not be of benefit related to development of febrile neutropenia, the ability to draw firm conclusions is limited by study design and other limitations. Ongoing research in the most cost effective way to prevent infection is needed.

Print

Minton, O., Richardson, A., Sharpe, M., Hotopf, M., & Stone, P. C. (2011). Psychostimulants for the management of cancer-related fatigue: a systematic review and meta-analysis. Journal of Pain and Symptom Management, 41, 761–767.

Purpose

To focus on the role of psychostimulants, particularly methylphenidate, in the treatment of cancer-related fatigue (CRF).

Search Strategy

Databases searched were MEDLINE, EMBASE, CINAHL, and Cochrane Register from inception to 2009.

Search keywords were not stated but appeared to be related to cancer-related fatigue and psychostimulants. According to the authors, “An exhaustive list of search terms was used and a systematic review methodology was applied.”

Studies were included if they were randomized, controlled trials testing a psychostimulant against a placebo or usual care in the treatment of CRF.

No exclusion criteria were stated.
 

Literature Evaluated

The total number of references retrieved was not stated. One author screened relevant titles and abstracts. The final list of included studies was agreed on by all the authors. Data were “extracted and independently reviewed using predesigned data extraction forms. Data were entered into Cochrane review manager software.” More information on search terms and numbers of articles initially reviewed would have been helpful; it was unclear as to who designed the “predesigned data extraction forms.”

Sample Characteristics

  • The final number of studies included was five.
  • The sample range across studies was 50 to 152 patients (N = 426 patients).
  • Minimal information was provided.
  • Mean age ranged from 50 to 71 years for the various studies (no range was provided).
  • There appeared to be various tumor types and treatment both current and past.
  • No other demographic data were provided.
     

Phase of Care and Clinical Applications

  • Patients were undergoing the transitional phase of care after initial treatment.
  • The study has clinical applicability for late effects and survivorship and palliative care.

Results

Four studies measured CRF with the Functional Assessment of Cancer Therapy–Fatigue (FACT-F), and one used the Brief Fatigue Inventory (BFI). There was a significant effect of psychostimulants over placebo (standardized mean difference = –0.28; 95% confidence interval [CI] [–0.48, –0.09]; p = 0.005). There was no difference in the rate of adverse effects between the drug and the placebo.

According to the authors, “evidence suggests that methylphenidate may be effective in management of CRF”; however, there was no large well-conducted clinical trial, and evidence from smaller trials was somewhat contradictory; thus, the authors stated “this advice must be considered to be tentative and provisional.”

Conclusions

Generally, this was a weak systematic review because the authors talked about performing an extensive search but provided no details about that search. The meta-analysis was also weak because only one (the largest) of the five studies showed improvement with psychostimulants compared to placebo.

Nursing Implications

Because there was no evidence about the long-term side effects of the medications, methylphenidate may best be used in patients with advanced disease or short-term use in those on active treatment. However, there was a trend toward benefit in some patients, and it may be worth a trial in selected patients as suggested by the authors.

Print

Minton, O., Richardson, A., Sharpe, M., Hotopf, M., & Stone, P. (2008). A systematic review and meta-analysis of the pharmacological treatment of cancer-related fatigue. JNCI: Journal of the National Cancer Institute, 100, 1155–1166.

Purpose

To examine the role of methylphenidate and other drugs in the management of cancer-related fatigue

Search Strategy

DATABASES: Cochrane Register of Controlled Trials, EMBASE, and hand searching of several journals and reference lists

KEYWORDS: neoplasms or cancer or carcinoma or tumour, bone marrow transplant, neutropenia, radiotherapy, fatigue. Complete listing of search terms is provided.

INCLUSION CRITERIA:

  • Randomized controlled trial
  • Designed to test a drug against placebo or usual care
  • Use of a multi-item measure of fatigue

EXCLUSION CRITERIA:

  • Measure of fatigue with single-item tool or visual analog scale

Literature Evaluated

TOTAL REFERENCES RETRIEVED: Initial searching provided 5,841 articles and abstracts for screening. One hundred sixteen were reviewed in detail.

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Studies were done from 1992–2007. Data were collected from studies on a standard form by two independent reviewers, and any differences were resolved by consensus.

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED = 27

SAMPLE RANGE ACROSS STUDIES = 12–939

TOTAL PATIENTS INCLUDED IN REVIEW: 6,568 

KEY SAMPLE CHARACTERISTICS: Samples included a variety of tumor types, a variety of treatments, and patients in active treatment as well as after treatment.

Results

Erythropoietin

Ten trials were included in meta-analysis.

  • Dosages ranged from 3,000–40,000 units, and frequency varied.
  • After 12 weeks of treatment, there was a significant reduction of fatigue (Z = 8.32, p <.001, SMD = -.038).
  • Most patients were anemic.
  • Half of the studies were open label.

Darbepoetin

Four trials were included in meta-analysis.

  • After 12 weeks of treatment, there was a significant effect compared with placebo (Z = 1.96, p = .05, SMD = -0.13).
  • All patients were anemic.

Paroxetine

Two studies were included.

  • After eight weeks of treatment, there was no fatigue benefit (Z = 1.06, p = -.29, SMD = -0.08).

Progestational Steroids

Four studies were included—three with megestrol acetate and one with medroxyprogesterone acetate.

  • After an average of eight weeks of treatment, no benefit was seen (Z = 1.06, p = .29, SMD = -0.18).
  • There was substantial heterogeneity among trials.
  • There was a consistent negative effect across all trials.

Methylphenidate

Two studies were included.

  • There was no overall benefit (Z = 0.63, p = .53).

Single studies

  • One study on 12 patients reported a significant effect of etanercept, an inhibitor of tumor necrosis factor.
  • One study on 466 women with metastatic breast cancer reported a significant effect of ibandronate compared with placebo.

Conclusions

Findings suggest that there is no overall, effective pharmacologic management of cancer-related fatigue. Meta-analysis of progestational steroids report an overall negative effect, suggesting that this approach is counterproductive for fatigue management.

Limitations

  • There is some expected bias in results due to lack of complete study data in some trials.
  • Overall effect sizes reported are small, so, though statistically significant, the actual effectiveness in the patient experience is unclear.

Nursing Implications

The majority of patients who were treated with hematopoietic growth factors were anemic, pointing to the need to correct anemia, rather than any direct effect on the symptom of fatigue. These results point to the need to clinically evaluate such potential causes of fatigue. Even in these cases, the effect size is relatively small.

Print

Minton, O., Richardson, A., Sharpe, M., Hotopf, M., & Stone, P. (2010). Drug therapy for the management of cancer-related fatigue. Cochrane Database of Systematic Reviews, 7, CD006704.

Purpose

To evaluate the effectiveness of pharmacologic interventions used for fatigue in patients with cancer

Search Strategy

Databases searched were PaPaS, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, Dissertation Abstracts International (DAI), metaRegister of Controlled Trials (mRCT) (January 2007–October 2009). Journals searched were British Journal of Cancer, Journal of Clinical Oncology, Journal of Pain and Symptom Management, and Journal of Palliative Medicine. The reference lists of all articles were checked for additional studies. Conference abstracts also were searched.

Search keywords were neoplasms, bone marrow transplantation, cancer, carcinoma, tumour, adenocarcinoma, leukemia, lymphoma, malignant, radiotherapy, fatigue, tired, weary, weariness, exhausted, lack or loss or lost energy or vigor, apathy or lassitude or lethargy, or feeling drained, sleepy, or sluggish.

Studies were included in the review if they

  • Assessed drug therapy for the management of cancer-related fatigue (CRF) compared to placebo, usual care, or a nonpharmacologic intervention.
  • Were randomized, controlled trials (single-blind and open-label were allowed).
  • Included adult patients with a clinical diagnosis of cancer.

Literature Evaluated

This review was an update of a previous review. The updated search retrieved 647 additional references. Of those, six additional studies met the inclusion criteria. The final sample of studies included was 31.

Sample Characteristics

The review included 7,104 participants who received a drug intervention for CRF.

Results

Psychostimulants

  • Four trials examined methylphenidate, and one used dexamphetamine. These included 426 patients total.
  • Evidence existed of a significant effect on fatigue with methylphenidate over placebo, and evidence supported the use of psychostimulants in the treatment of CRF.
  • The standardized mean difference was positive, with a small effect and narrow confidence interval (CI) (total mean difference = –0.28; 95% CI [-0.48, -0.09]; Z = 2.83; p = 0.005).
  • Fatigue was measured with the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) in all studies.

Erythropoietin and Darbepoetin

  • Eleven studies were combined in total and demonstrated a positive effect. The weighted mean difference of studies using the FACT-F outcome measure in erythropoietin gave a score of 4.33, which was a clinically significant difference. The conclusion was limited to patients with anemia who were undergoing chemotherapy. Greater improvement was more likely in those with lower hemoglobin levels.
  • In placebo-controlled trials of darbepoetin, the mean difference using the FACT-F score was -1.96, which was less than the minimally clinical significant difference.
  • Combined analysis for both agents gave a mean difference score of 3.75, which was clinically significant. 
  • Erythropoietin and darbepoetin cannot be recommended because of adverse events associated with these drugs.

Antidepressants/Paroxetine

  • Two studies using paroxetine and a trial using sertraline were analyzed. Analysis showed no benefit for the treatment of CRF.

Progestational Steroids

  • In studies that could be combined, no evidence existed to support continued use for the treatment of fatigue.
  • The clinical significance of results of ibandronate were unclear.
  • One study of etanercept during chemotherapy had statistically significant results, but the study had a small sample size and poor design. It was suggested that additional trials be conducted.
  • One study of donepezil showed no benefit over placebo.

Conclusions

Four trials of methylphenidate provided evidence for use that was supportive but associated with a small effect size in a dose of 10–20 mg per day. Serious adverse events were minimal; however, clinicians need to review contraindications before prescribing. Additional large-scale trials were suggested using methylphenidate to further evaluate use in CRF. Erythropoietin and darbepoetin can no longer be recommended for CRF because of increased adverse events associated with these drugs. No current evidence exists to support the use of steroids.

Limitations

  • Reviewers found major limitations in the reporting of trials and multiple methods of measuring outcomes.
  • Some outcomes in trials were not reported due to extensive missing data.
  • These findings point to the need for improved research reporting to meet Consolidated Standards of Reporting Trials (CONSORT) guidelines and the benefit that could be derived from use of consistent methods of measuring outcomes.
Print

Minkowitz, H., Bull, J., Brownlow, R.C., Parikh, N., & Rauck, R. (2016). Long-term safety of fentanyl sublingual spray in opioid-tolerant patients with breakthrough cancer pain. Supportive Care in Cancer, 24, 2669–2675. 

Study Purpose

To assess the long-term safety of fentanyl sublingual spray for breakthrough cancer pain

Intervention Characteristics/Basic Study Process

An initial titration phase was used to determine dosing for new patients. Additional patients were continued on the medication after their involvement in a prior double-blind randomized trial. The study was conducted for 90 days. Follow-up was conducted by telephone 30 days after trial completion or patient withdrawal. Study measures were obtained monthly.

Sample Characteristics

  • N = 163
  • MEAN AGE = 53.6 years
  • MALES: 47.6%, FEMALES: 52.4%
  • CURRENT TREATMENT: Combination radiation and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Not provided
  • OTHER KEY SAMPLE CHARACTERISTICS: 20% were undergoing chemotherapy. Most had mild to moderate background pain and breakthrough episodes moderate in intensity for a duration of 60 minutes, which occurred a mean of three times daily.

Setting

  • SITE: Multi-site
  • SETTING TYPE: Not specified
  • LOCATION: United States, Canada, and India

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Palliative care 

Study Design

  • Open label

Measurement Instruments/Methods

  • Adverse events
  • Treatment Satisfaction Questionnaire for Medication (TSQM)

Results

Of the patients, 80% achieved an effective dose during titration. The median effective dose was 600 mcg, and the range of daily dosing during maintenance was 140–9,381 mcg. Three patients had adverse events possibly related to the study medication, and 7.4% had application site irritation during the titration phase, but no patients had this problem during the maintenance phase. In addition, 87% were satisfied to extremely satisfied with effectiveness of the analgesia during the maintenance period.

Conclusions

Findings suggest that fentanyl submucosal spray is well tolerated over several months of use.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • No measurement of efficacy for pain—study objectives were just to evaluate safety

Nursing Implications

Findings suggest that submucosal fentanyl spray is well tolerated for relatively long-term use.

Print

Mineo, T.C., Sellitri, F., Tacconi, F., & Ambrogi, V. (2014). Quality of life and outcomes after nonintubated versus intubated video-thoracoscopic pleurodesis for malignant pleural effusion: Comparison by a case-matched study. Journal of Palliative Medicine, 17, 761–768. 

Study Purpose

To evaluate outcomes after video-assisted thoracic surgery pleurodesis among intubated patients and unintubated patients under local anesthesia

Intervention Characteristics/Basic Study Process

Consecutive patients who received unintubated video-assisted pleurodesis were matched with patients who preferred general anesthesia and were intubated for the procedure. Data were obtained from a retrospective review. Cases were matched on age, gender, performance status, history, and type of tumor. Patients with extrathoracic metastases were excluded. Patients received intercostal blocks and sedation with remifentanil. For the intubated group, general anesthesia was induced with propofol, fentanyl, and vecuronium. Talc was used for pleurodesis in both groups. Postoperative management was the same in both groups.

Sample Characteristics

  • N = 462–231 (intervention group)  
  • MEAN AGE = 64.3 years
  • MALES: 55%, FEMALES: 45%
  • KEY DISEASE CHARACTERISTICS: Multiple tumor types with secondary pleural malignancy; most common was lung cancer followed by breast cancer

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Palliative care 

Study Design

Retrospective, descriptive study with a matched control comparison

Measurement Instruments/Methods

  • European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ C30)

Results

Anesthesia time (p < 0.0001) and recovery room time (p = 0.0002) were significantly shorter in the unintubated group. Postoperative hospital stays were 1.8 days shorter on average in the unintubated group (p = 0.011), and postoperative morbidity (p = 0.042) and mortality (p = 0.017) were lower in the unintubated group. Pleurodesis was successful in more than 83% of patients in both groups, and costs were lower in the unintubated group. Physical function (p < 0.05) and dyspnea (p < 0.01) were more improved in the short-term among the unintubated patients. There was a higher rate of major subcutaneous emphysema in the unintubated group. There were no differences between the groups in effusion-free time or overall survival.

Conclusions

Video-assisted pleurodesis under local anesthesia without the need for intubation was associated with shorter postoperative hospital stays, fewer short-term postoperative issues, and improved dyspnea compared to similar patients who received traditional pleurodesis under general anesthesia.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Other limitations/explanation: The study included people with good performance statuses, so findings may not be applicable to those with poorer physical conditions overall.

Nursing Implications

The performance of pleurodesis under local anesthesia with video-assisted thoracic surgery was shown to improve short-term postoperative outcomes compared to procedures done under general anesthesia in this study. There were some differences in postoperative complications between patients who had general anesthesia versus those who did not, so nurses need to be aware of the potential differences in complications according to the type of procedure done and assess patients accordingly. The applicability and safety of this approach in patients with very poor overall performance status is not clear.

Print

Minchom, A., Punwani, R., Filshie, J., Bhosle, J., Nimako, K., Myerson, J., . . . O'Brien, M.E. (2016). A randomised study comparing the effectiveness of acupuncture or morphine versus the combination for the relief of dyspnoea in patients with advanced non-small cell lung cancer and mesothelioma. European Journal of Cancer, 61, 102–110.

Study Purpose

To investigate the use of acupuncture for the relief of dyspnea

Intervention Characteristics/Basic Study Process

Patients were randomized to acupuncture alone, morphine and acupuncture, or morphine alone groups. Patients in the acupuncture alone arm were provided morphine for rescue if needed. Oral morphine at 2.5 mg every four hours with breakthrough doses were given to the morphine group. In the combination group, patients received morphine before acupuncture. Study measures were conducted at 30 minutes, 90 minutes, 4 hours, and on days 2, 7, and 14.

Sample Characteristics

  • N = 145, 175 in intent-to-treat analysis 
  • MEDIAN AGE = 73 years
  • MALES: 65.1%, FEMALES: 44.9%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Non-small cell lung cancer or mesothelioma
  • OTHER KEY SAMPLE CHARACTERISTICS: The baseline mean visual analog scale (VAS) for dyspnea was 6.5.

Setting

  • SITE: Single site   
  • SETTING TYPE: Not specified    
  • LOCATION: United Kingdom

Phase of Care and Clinical Applications

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

Study Design

Three-group, randomized trial

Measurement Instruments/Methods

  • Forced expiratory volume measured during the first second of forced breath (FEV1)
  • Peak expiratory flow rate (PEFR)
  • Hospital Anxiety and Depression (HADS) scale for anxiety
  • Borg Dyspnea Scale
  • European Organization for Research and Treatment of Cancer (EORTC) QLC-30 questionnaire for quality of life
  • Visual analog scale (VAS) dyspnea and anxiety

Results

No difference existed between groups in VAS dyspnea scores from baseline to after the interventions. VAS scores for anxiety declined in the acupuncture-only group (p < 0.001) and the combination group (p < 0.001) compared to the morphine-only group by day 14. At 30 minutes, Borg Dyspnea Scale scores were lower in the groups receiving acupuncture compared to the morphine-only group (p = 0.003). Twenty-one percent of patients receiving acupuncture took morphine as a rescue medication.

Conclusions

Acupuncture may play a role in the management of dyspnea in patients with advanced lung cancer; however, additional research is needed to determine efficacy and determine how it is best provided.

Limitations

  • Risk of bias (no blinding)
  • Measurement/methods not well described
  • Intervention expensive, impractical, or training needs
  • Subject withdrawals ≥ 10% 
  • It appears that acupuncture was provided once, but the timing was not clearly stated.
  • Although VAS scores for anxiety showed a response, HAD scale scores did not.

Nursing Implications

Acupuncture may have some benefit in the management of dyspnea in patients with advanced disease; however, additional research in this area is needed.

Print
Subscribe to