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Forastiere, E., Sofra, M., Giannarelli, D., Fabrizi, L., & Simone, G. (2008). Effectiveness of continuous wound infusion of 0.5% ropivacaine by On-Q pain relief system for postoperative pain management after open nephrectomy. British Journal of Anaesthesia, 101(6), 841–847.

Study Purpose

To compare, after open nephrectomy, the efficacy of continuous wound site infusion with ropivacaine with that of saline; to examine morphine consumption, side effects, bowel function, and hospital length of stay in two study arms

Intervention Characteristics/Basic Study Process

Patients received continuous surgical wound site infusion of either 0.5% ropivacaine or 0.9% saline. For breakthrough pain, all patients received standard care with PCA morphine and ketorolac.

Sample Characteristics

  • The sample was composed of 168 patients.
  • The age range of patients was 47–71 years. In the ropivacaine group, the mean age was 58.7 years. In the saline group, the mean age was 60.2 years.
  • Of all patients, 61% were females and 38.1% were males.
  • During the study all patients underwent open nephrectomy through lumbotomic access. Authors did not report underlying diagnoses.

Setting

  • Single site
  • Inpatient
  • Rome, Italy

Study Design

Prospective randomized, double-blinded, placebo-controlled study

Measurement Instruments/Methods

  • Visual analog scale, 0–10 score, to measure incident pain at mobilization
  • Consumption of PCA morphine
  • Time to bowel recovery
  • Level of sedation
  • Length of hospital stay

Results

  • Pain at rest and while coughing was significantly less (p < 0.0001) in the ropivacaine group than in the control group.
  • Morphine consumption was significantly greater in the control group than in the ropivacaine group. Mean total morphine consumption was significantly greater in the control group (p < 0.0001).
  • Compared to the control group, time to bowel recovery was significantly shorter and sedation was less in the ropivacaine group (p < 0.0001).
  • Time to discharge was 3.2 days in the control group versus 2.1 days in the ropivacaine group (p < 0.001).
  • Use of ropivacaine resulted in substantial cost savings per patient, primarily because ropivacaine was associated with shorter length of stay.

Conclusions

Continuous wound infusion with ropivacaine improved pain relief and accelerated recovery and discharge.

Limitations

A single surgeon peformed all procedures and placed all catheters. Because of the various locations of nociceptive receptors, this makes generalizing study findings questionable; placement of catheters for local infusion relates to results.

Nursing Implications

Multimodal pain management that includes continuous wound infusion of anesthetic and systemic opioid can reduce postoperative pain, thereby reducing length of stay and hospitalization costs.

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Fong, S.S., Ng, S.S., Luk, W.S., Chung, J.W., Ho, J.S., Ying, M., & Ma, A.W. (2014). Effects of qigong exercise on upper limb lymphedema and blood flow in survivors of breast cancer: A pilot study. Integrative Cancer Therapies, 13, 54–61.

Study Purpose

To investigate the effects of qigong exercises on upper extremity lymphedema, arterial resistance, and blood flow velocity in breast cancer survivors

Intervention Characteristics/Basic Study Process

Experimental group performed approximately six minutes of the 18 forms tai chi qigong exercises, and the control group rested.

Sample Characteristics

  • N = 23
  • MEAN AGE = 58 years (intervention), 54 years (control)
  • MALES: 0%, FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Females older than age 18, treated with mastectomy, lymphedema of greater than 2 cm circumferential measurement in affected versus unaffected extremity, no known neurological deficits
  • OTHER KEY SAMPLE CHARACTERISTICS: Exclusions included current adjuvant treatment, recurrence of disease, lumpectomy, pregnancy, or performing other regular exercise.

Setting

  • SITE: Single site 
  • SETTING TYPE: Outpatient 
  • LOCATION: Hong Kong

Phase of Care and Clinical Applications

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

Study Design

  • Pilot, single-blind, nonrandomized, controlled trial

Measurement Instruments/Methods

  • Circumferential limb volume
  • Tape measurement
  • Doppler for arterial resistance
  • Resistance Index

Results

There was an immediate circumferential decrease and blood flow resistance decrease, with increase in blood flow velocity in the experimental group. However, no girth changes between groups may indicate only temporary effects.

Conclusions

More rigorous randomized, controlled studies are needed to confirm the effects of this exercise.

Limitations

  • Small sample (< 30)
  • Risk of bias (no random assignment)
  • Findings not generalizable

Nursing Implications

Nurses should encourage limb movement and range of motion exercises for breast cancer survivors.

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Fong, D.Y., Ho, J.W., Hui, B.P., Lee, A.M., Macfarlane, D.J., Leung, S.S., . . . Cheng, K.K. (2012). Physical activity for cancer survivors: Meta-analysis of randomised controlled trials. BMJ, 344, e70.

Purpose

STUDY PURPOSE: To evaluate the evidence regarding the effects of physical activity in cancer survivors

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: Medline, CINAHL, and Google Scholar
 
KEYWORDS: Detailed keywords provided including multiple terms for cancer, treatment type, and exercise and activity
 
INCLUSION CRITERIA: Randomized, controlled trials; adult patients; patients who completed initial cancer treatment; assessed effects of physical activity
 
EXCLUSION CRITERIA: None specified

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 1,892 (387 identified through sources other than the search)
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Study quality was assessed using a checklist from the Scottish Intercollegiate Guidelines Network.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 54 in qualitative review and 34 in meta-analysis
  • SAMPLE RANGE ACROSS STUDIES: Median sample size was 93 patients
  • KEY SAMPLE CHARACTERISTICS: Various tumor types with the most common being breast, colorectal, and endometrial; mean age was 55 years (range = 39–74 years)

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship

Results

The median duration of the exercise intervention was 13 weeks (range = 3–60). A meta-analysis of results for body mass index, body weight, and other physiologic measures was reported. A meta-analysis was completed for three studies regarding effect on fatigue, and slightly reduced fatigue was demonstrated using the Piper Fatigue Scale (p = 0.03). However, sample sizes were small in these studies. A meta-analysis of effects on depression included four studies and showed reduced depression using the Beck Depression Inventory (p < 0.01). Three of the four studies had relatively small sample sizes. Quality of life outcomes showed improved Short Form-36 physical functioning scores (p = 0.01) and mental health scores (p = 0.01). The authors noted substantially different results based on the measurement scales used in the included studies.

Conclusions

This analysis supports the effectiveness of exercise in general on cancer-related fatigue and depression.

Limitations

It was suggested that the intensity of the exercise could affect results, and intensity was not consistently reported in the studies included. The mean duration of the intervention was as high as 13 weeks and as low as three weeks. The relatively short duration limits the ability to assess long-term outcomes. Most studies were completed in patients with breast cancer. There were very few studies in the analysis, and it was surprising that more studies were not found for inclusion. The studies of fatigue and depression included in this meta-analysis had relatively small sample sizes.

Nursing Implications

This report adds to the already large body of evidence demonstrating that exercise can improve fatigue and depression outcomes in cancer survivors. Current evidence, however, involves relatively short-term interventions and assessments. For long-term benefits, it is generally believed that physical activity needs to be incorporated into everyday life. Nursing interventions and future research should consider the examination of approaches to address this need for ongoing behavior change. Most exercise studies continue to involve women with breast cancer. Although there is some evidence in other groups, it is limited. Continued research to examine exercise's effects in more varied patients would be beneficial.

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Focht, B.C., Clinton, S.K., Devor, S.T., Garver, M.J., Lucas, A.R., Thomas-Ahner, J.M., & Grainger, E. (2013). Resistance exercise interventions during and following cancer treatment: A systematic review. Journal of Supportive Oncology, 11, 45–60. 

Purpose

STUDY PURPOSE: To review the effects of resistance exercise (RE) interventions on clinically relevant physiologic and quality of life (QOL) outcomes during and following cancer treatment and to calculate the magnitude of the change in these outcomes following
 
TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: PubMed and MEDLINE databases
 
KEYWORDS: Resistance exercise with related terms and cancer with related terms
 
INCLUSION CRITERIA: Those that included an RE intervention in isolation among patients with cancer or survivors were included. RE was defined as regular participation in a structured, repetitive strength training program over an extended period of time with the goal of improving health or fitness outcomes. Studies targeting individuals diagnosed with cancer who were actively undergoing cancer treatment or had successful cancer treatment with a curative intent were included. All study designs were included. 
 
EXCLUSION CRITERIA: RE in combination with other exercise, lifestyle, or behavioral interventions

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 417 
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: During data extraction by two reviewers, any instances of disagreement were resolved by a consensus of all authors. Quality was assessed by two independent reviewers using seven quality indicators from he Delphi List, a consensus criteria list for quality assessment in randomized, controlled trials. Quality indicators were listed.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 15
  • TOTAL PATIENTS INCLUDED IN REVIEW = 1,077
  • KEY SAMPLE CHARACTERISTICS: Six studies addressed RE during treatment, and four were conducted during androgen deprivation therapy, one during chemotherapy, and two during radiation therapy. The remaining nine studies focused on RE in participants following the completion of active cancer treatment with a curative intent. This included participants with BRCA (n = 6), prostate cancer (n = 4), head and neck cancer (n = 3), lung cancer (n = 1), and a mixed group (n = 1).

Results

Pertaining to fatigue outcomes, two randomized, controlled design studies showed insignificant changes in fatigue with BRCA survivors. One nonrandomized trial showed insignificant change in patients with prostate cancer. Two randomized, controlled studies showed moderate to large effect sizes in patients with BRCA and prostate cancer patients over time after three and six months. Large effects were seen in the Schmidt study with BRCA survivors. A moderate effect was seen in the Segal study of patients with prostate cancer receiving androgen deprivation therapy. Small effect sizes were seen in BRCA patients undergoing chemotherapy at a midpoint and post-treatment.

Conclusions

The results of this study suggested that RE may improve fatigue in patients with BRCA undergoing chemotherapy, patients with prostate cancer undergoing androgen deprivation therapy, and in BRCA survivors.

Limitations

Although methodologic quality was good overall, an increase of intent-to-treat analyses of future randomized, controlled trials is needed.

Nursing Implications

Few studies examined this type of exercise, and additional study is indicated.

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Fobair, P., Koopman, C., DiMiceli, S., O'Hanlan, K., Butler, L. D., Classen, C., . . . Spiegel, D. (2002). Psychosocial intervention for lesbians with primary breast cancer. Psychooncology, 11, 427–438.

Intervention Characteristics/Basic Study Process

The intervention included twelve 90-minute meetings of a supportive-expressive group therapy led by a licensed clinical social worker; participants discussed problems, coping, treatment, mood, self-efficacy, relationships, pain, sleep, body image, and sexuality. Outcomes were emotional distress, mood, self-efficacy, body image, sexuality, social support, quality of life (QOL), pain, and sleep.

Sample Characteristics

  • The sample comprised 20 patients with stage I to IIIA breast cancer.
  • Mean age was 47 years.
  • Patients were post surgery.

Setting

Three community settings in Northern California

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

The study used a one-group, pre-/posttest design.

Measurement Instruments/Methods

Brief questionnaire based on the Structured Insomnia Interview to assess quality and quantity of sleep and daytime sleepiness

Results

Patients undergoing 12 weeks of supportive group therapy showed statistically significant improvement in sleep (less waking during the night).

Limitations

  • The study had a small sample size and lacked a control group.
  • Training is required to observe for unstable emotional status.
  • A licensed clinical social worker familiar with supportive-expressive group therapy is needed.
  • Cost is incurred for a space for the class and the instructor.
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Fluhr, J.W., Miteva, M., Primavera, G., Ziemer, M., Elsner, P., & Berardesca, E. (2007). Functional assessment of a skin care system in patients on chemotherapy. Skin Pharmacology and Physiology, 20, 253–259.

Study Purpose

To evaluate the effectiveness of concomitant treatment with a cleanser (slight acidic washing) and a slightly acidic emollient (both pH 5.5) in improving symptoms of xerosis in patients receiving chemotherapy.

Sample Characteristics

  • The study reported on a sample of 30 adult patients.
  • Patients had gastrointestinal, breast, prostate, and lung cancers, and lymphoma; were receiving chemotherapy; and were experiencing dry, sensitive skin.

Setting

This study was conducted at Friedrich-Schiller University in Jena, Germany, and at Istituto Dermatologico San Gallicano in Rome, Italy.

Study Design

This was a controlled, monocentric, three-week treatment trial.

Measurement Instruments/Methods

  • Patients were assessed on days 0, 7, 14, and 21 with four electronic devices.
    • Skin pH-Meter® PH 900 to assess skin pH
    • Tewameter® TM 300 to measure transepidermal water loss (TEWL)
    • Corneometer® CM 825 to measure capecitabine-based skin hydration
    • Sebumeter® SM 815 to measure casual surface sebum content
  • Physician clinical assessment included the following.
    • Estimation of dryness symptoms with an original scale from 0 to 4
    • Visual assessment of perceived skin change with a 10-point scale
    • Physicians and patients gave subjective assessment on a questionnaire about the tolerability of both products.

Results

  • A significant reduction in TEWL (p < 0.007) was noted over time on the treated forearm.
  • Compared to baseline, sebum content hydration values increased significantly until the end of the study (p < 0.001).
  • Casual skin surface lipids increased significantly on the treated forearm (p < 0.03).
  • No significant difference existed in pH values on both the treated and untreated forearms.
  • For the physicians' clinical assessment, a progressive improvement of all skin symptoms was recorded in the course of treatment, whereas the lowest values (e.g., the best results) were obtained on the last examination day (p < 0.001).
  • The visual assessment of the perceived change in skin state showed a significant improvement over the course of the study.
  • Both the physicians and patients considered the application of the treatment tolerable enough with a good cleansing effect, leaving a nice sensation after use.

Conclusions

Concomitant treatment with a cleanser (slight acidic washing) and a slightly acidic emollient (both pH 5.5) was effective in improving symptoms of xerosis in patients receiving chemotherapy.

Limitations

  • The study was not randomized or double blinded.
  • The study was funded by Sebapharma, whose products were used.
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Flores, I.Q., & Ershler, W. (2009). Managing neutropenia in older patients with cancer receiving chemotherapy in a community setting. Clinical Journal of Oncology Nursing, 14, 81–86.

Study Purpose

The purpose of the study was to compare the use of pegfilgratim in all chemotherapy cycles with pegfilgrastim use at the clinician’s discretion for the reduction of febrile neutropenia, grade 3 or 4 neutropenia, dose delay, dose reduction, hospitalization, antibiotic use, and infections in older adults with cancer.

Intervention Characteristics/Basic Study Process

Study period was June 2002 to Nov 2004.

Older adults with cancer of the breast, ovary, lung, or aggressive non-Hodgkin lymphoma (NHL) were randomized to pegfilgrastim (subcutaneous injection 6 mg one time per cycle 24 hours after chemotherapy completion staring with cycle one) or secondary prophylaxis with pegfilgrastim (subcutaneous injection 6 mg one time per cycle 24 hours after chemotherapy completion staring after cycle one at physician’s discretion [discretion may be in response to severe neutropenia, netropenia-related events during chemotherapy, dose delays, dose reductions, or no changes in dose or timing]).

Sample Characteristics

  • The total sample size was 852.
  • All participants were aged 65 years and older.
  • The amount of women was 548; the amount of men was 304.
  • Key disease characteristics were lung, breast, or ovarian cancer or aggressive NHL.
  • In the solid tumor and NHL groups, each of the following age groups were comprised of 33% of the patients: 65–69 years old, 70–74 years old, and 75 years and older.
  • 90% were Caucasian and 90% had an ECOG score of 0 or 1.
  • The majority of all patients were diagnosed with disease stage III or IV.

Setting

  • Multi-site  
  • Outpatient setting  
  • Community cancer centers nationwide

Phase of Care and Clinical Applications

  • The phase of care was active treatment
  • Application was for elderly care

Study Design

Phase IV, open-label, randomized, multicenter, community-based trial

Measurement Instruments/Methods

  • Febrile neutropenia 
  • Grade 3 neutropenia
  • Chemotherapy regimen
  • Solid tumor type
  • Pegfilgrastin administered
  • Dose delay, dose reduction, hospitalization, and antibiotic use

Results

701 patients with solid tumors. Fifteen were excluded, making the sample size 686 (343 in the pegfilgrastim arm, 343 in the physician discretion arm). Those who completed the study in each arm was 198 in the pegfilgrastim arm  and 175 in the physician discretion arm. Forty-two percent of patients in the discretion arm received pegfilgrastim, most often for grade 3 or 4 neutropenia. There were 151 patients with NHL. Five were excluded, making the sample size 146 (73 in the pegfilgrastim arm, 73 in the physician discretion arm). Thirty-eight patients in each arm completed the study. In the discretion arm, 64% received pegfilgratim.
 

Febrile neutropenia was lower in the all-cycle pegfilgrastim arm compared to the discretion arm, with a 60% reduction in incidence of febrile neutropenia for patients with solid tumors (p = 0.001) and 59% reduction of febrile neutropenia for patients with NHL (p = 0.004). Grade 4 febrile neutropenia was 22% for patients with solid tumors and 75% for patients with NHL in the all-cycle pegfilgrastim arm compared to 58% for patients with solid tumors and 86% for patients with NHL in the discretion arm. Rates of febrile neutropenia in the first cycle for patients with solid tumors were 3%, and 7% for NHL patients in the all-cycle pegfilgrastim arm compared to 7% for solid tumors and 25% for NHL patients in the discretion arm.


Overall, for patients with solid tumors, the all-cycle pegfilgrastim arm had lower rates of grade 3 or 4 neutropenia, dose delays, dose reductions, decreased hospitalizations, and decreased antibiotic use compared to the discretion arm; and similarly for patients with NHL with the exceptions of higher rates of dose delay and dose reductions in the all-cycle pegfilgrastim arm. None of these findings were statistically significant.
 

The most serious adverse event related to pegfilgrastim use was bone pain (12%) in the solid tumor group and in the NHL group (9%) for those receiving all-cycle pegfilgrastim compared to 5% and 4%, respectively, for the discretion arm.

Conclusions

Pegfilgrastin use in older adults undergoing chemotherapy for cancer of the lung, breast, or ovary, or for NHL is safe and effective with use starting in the first cycle for the reduction of febrile neutropenia, grade 3 or 4 neutropenia, febrile neutropenia-related hospitalizations, and antibiotic use. Dose delay and dose reduction were shown to be increased for patients with NHL who received pegfilgrastin at all cycles compared to physician discretion, which may be due to increased use of pegfilgrastin through physician discretion in this population. In addition, due to the use of pegfilgrastin by physician discretion as the comparison group and the unknown information about frequency of dosing in the discretion arm outside of the majority beginning pegfilgrastin treatment following a grade 3 or 4 febrile neutropenic event, coupled with limited statistically significant outcomes, it is difficult to have a definitive conclusion based on these findings. Clinically, however, the outcomes do appear favorable towards use of pegfilgrastin beginning with the first cycle.

Limitations

  • This study was funded by Amgen, the manufacturer of pegfilgrastim, and the study was not blinded. 
  • The use of pegfilgrastim for neutropenia and related adverse events in patients with other types of malignancies were not evaluated in this study.
  • Fewer patients with NHL were able to be randomized to the discretion arm since physicians often wanted pegfilgrastim started early in these patients due to known neutropenic outcomes.
  • In addition, this article was a replication of the article by Balducci et al. (2007), which was the original report of the findings; therefore, this article published two years after the original does not add to the knowledge of efficacy of use of pegfilgrastim.

Nursing Implications

The administration of pegfilgrastin starting with the first cycle of chemotherapy may reduce neutropenic events and related complications in older adults with cancer. Nurses can be at the forefront of advocating for this therapy, administering it, and monitoring patients for effective outcomes and/or adverse events.

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Flieger, D., Klassert, C., Hainke, S., Keller, R., Kleinschmidt, R., & Fischback, W. (2007). Phase II clinical trial for prevention of delayed diarrhea with cholestyramine/levofloxacin in the second-line treatment with irinotecan biweekly in patients with metastatic colorectal carcinoma. Oncology, 72(1–2), 10–16.

Intervention Characteristics/Basic Study Process

Patients receiving 250 mg/m2 IV irinotecan over 90 minutes every two weeks were given 500 mg levofloxacin tablets once at 8 pm and 4 g cholestyramine three times per day (not together with other medications) beginning the day before chemotherapy to day +1. Patients with acute cholinergic syndrome, abdominal cramping, and early diarrhea, were given 0.25-1 mg IV atropine. Patients experiencing delayed diarrhea were offered loperaminde.

Sample Characteristics

  • The study reported on 51 patients with metastatic colorectal cancer (CRC) in second-line treatment.
  • Mean age was 64 with a range of 41–81.
  • Patients had not received prior irinotecan therapy and were refractory or resistant to 5-fluorouracil (5-FU).

Study Design

This was a phase II trial.

Measurement Instruments/Methods

  • Patients recorded diarrhea incidence and severity in diaries following each chemotherapy dose.
  • Diarrhea severity was measured using World Health Organization (WHO) grading.

Results

  • Forty patients (78%) did not develop diarrhea, 11 patients (22%) reported WHO grade 1–2 diarrhea, and only one patient (2%) reported WHO grade 3 diarrhea.
  • No patients reported grade 4 diarrhea. 
  • Reported incidence of diarrhea without prophylaxis in the literature is up to 40%.

Limitations

  • The study sample was small.
  • This was a phase II study.
  • Investigators did not conduct pharmacokinetic analyses of the active metabolites SN-38 and SN-38G in plasma.
  • No information was provided on the effect of cholestyramine on the efficacy of irinotecan efficacy. If cholestyramine decreases the effects of irinotecan, this could account for a decreased incidence of diarrhea.

Nursing Implications

Combination cholestyramine and levofloxacin is a promising option for prevention of delayed diarrhea caused by irinotecan and may help to escalate the dose of irinotecan in the future.

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Fletcher, D.S., Coyne, P.J., Dodson, P.W., Parker, G.G., Wan, W., & Smith, T.J. (2014). A randomized trial of the effectiveness of topical "ABH Gel" (Ativan®, Benadryl®, Haldol®) versus placebo in cancer patients with nausea. Journal of Pain and Symptom Management, 48(5), 797–803.

Study Purpose

To determine the effectiveness of ABH gel (containing Ativan®, Benadryl®, and Haldol®) on chemotherapy-induced nausea and vomiting (CINV) in patients with cancer

Intervention Characteristics/Basic Study Process

The ABH gel or “cocktail” was prepared by the investigational pharmacy in 10 ml gel form (consisting of lorazepam 20 mg, Benadryl® 250 mg, Haldol® 20 mg, lecithin organogel 2 ml, ethoxydiglycol 0.83 ml, water 0.2 ml, and pluronic gel 20%). This gel-form cocktail yielded 10 doses of 1.0 ml with each application to be dispensed in individual syringes. A placebo gel was prepared using an inactive pluronic lecithin organogel alone.
 
The study participants were instructed to place their designated 1.0 ml of the study gel on the palmar aspect of their wrists using a prefilled syringe, and to rub their wrists together for two minutes. Nausea scores were recorded before the gel was applied and then at 30, 60, 90, 120, 180, and 240 minutes after the gel was applied. If the first ABH gel treatment was ineffective, the patients were asked to apply a second gel treatment. After two hours, if the second gel treatment also failed or for uncontrolled nausea, the researchers used the traditional pharmacological treatment.

Sample Characteristics

  • N = 22  
  • MEAN AGE = 47.1 years (range = 18–72 years)
  • MALES: 6 (27.3%), FEMALES: 16 (72.7%)
  • KEY DISEASE CHARACTERISTICS: The majority of the enrolled patients were status post–bone marrow transplant and other types of cancer, but the types of cancer were not specified.  
  • OTHER KEY SAMPLE CHARACTERISTICS: Twenty patients had Hispanic or Latino background, 16 patients were Caucasian, and six were African American.

Setting

  • SITE: Single-site    
  • SETTING TYPE: Multi-site  
  • LOCATION: An outpatient bone marrow transplant clinic and an inpatient palliative care unit at the Virginia Commonwealth University Massey Cancer Center in Richmond, United States

Phase of Care and Clinical Applications

  • APPLICATIONS: Palliative care

Study Design

A randomized, double-blind, placebo-controlled, crossover, noninferiority clinical trail

Measurement Instruments/Methods

  • The Condensed Memorial Symptom Assessment Scale (CMSAS) was used to assess the symptoms of nausea.

Results

In total, 22 patients enrolled in the study. However, 20 patients completed both arms (treatment and placebo) as a crossover. In the results section, the researcher listed three important findings: the mean change in the nausea score from baseline to 60 minutes post-treatment in both groups was not statistically significant; the ABH gel was not topically absorbed well even four hours after application; and almost 67% of the study patients stated that treatment was not effective in relieving symptoms.

Conclusions

The researchers concluded that the ABH gel in its current formulation should not be used for patients with cancer.

Limitations

  • Small sample (< 30)

 

Nursing Implications

The same authors also demonstrated similar results in healthy volunteers in their previously published study in the May 2012 issue of the same journal titled “ABH Gel is not Absorbed From the Skin of Normal Volunteers,” which found that ABH gel is not absorbed well topically. In that study, lorazepam and Haldol® were almost undetectable in the blood samples of healthy study subjects; in other words, the plasma samples indicated that ABH gel was clinically or therapeutically insignificant. Therefore, ABH gel in its current formulation should not be used in patients with cancer.

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Flerlage, J.E., & Baker, J.N. (2015). Methylnaltrexone for opioid-induced constipation in children and adolescents and young adults with progressive incurable cancer at the end of life. Journal of Palliative Medicine, 18, 631–633. 

Study Purpose

To describe the use of methylnaltrexone (MNTX) in pediatric patients with cancer in both inpatient and outpatient settings

Intervention Characteristics/Basic Study Process

A retrospective chart review was conducted on all children, adolescents, and young adults with incurable cancer treated at St. Jude Hospital from May 2008 to June 2013. Pharmacy data and chart data were reviewed for inclusion data. Patients had documented OIC and the administration of enteral preparations and/or suppositories to treat OIC. After standard therapy for OIC was not successful, MNTX was administered subcutaneously at 0.15 mg/kg per dose.

Sample Characteristics

  • N = 9  
  • AGE RANGE = 17 months-21 years
  • MALES: 44%, FEMALES: 56%
  • KEY DISEASE CHARACTERISTICS: Progressive, incurable cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Children, adolescent, and young adult

Setting

  • SITE: Single site  
  • SETTING TYPE: Multiple settings    
  • LOCATION: Memphis, TN

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS: Pediatrics and palliative care 

Study Design

  • Retrospective chart review (RCR)

Measurement Instruments/Methods

  • Data collection tool specific to this study was used.

Results

MNTX administration produced bowel function in seven (78%) of the patients in one hour and with five (71%) of the patients having a response to first dose. With repeated dosing, 71% had continued response. There were no side effects documented. Two patients responded to repeated doses. The drug was effective in four of five patients with intra-abdominal disease.

Conclusions

The study revealed that MNTX can be safe and effective in children, adolescents, and young adults with OIC and end-of-life disease.

Limitations

  • Small sample (less than 30)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment) 
  • Risk of bias (no appropriate attentional control condition)
  • Measurement/methods not well described
  • Measurement validity/reliability questionable
  • Findings not generalizable

Nursing Implications

OIC is a distressing side effect of opioid pain management. The use of MNTX in pediatric patients with cancer with progressive disease appears to be an effective and safe in this retrospective audit, but prospective randomized clinical trials are required.

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