Barnes, H., McDonald, J., Smallwood, N., & Manser, R. (2016). Opioids for the palliation of refractory breathlessness in adults with advanced disease and terminal illness. Cochrane Database of Systematic Reviews, 3, CD011008.
STUDY PURPOSE: To evaluate the effectiveness of opioids in relieving the symptom of dyspnea in people with advanced disease
TYPE OF STUDY: Meta-analysis and systematic review
PHASE OF CARE: End-of-life care
APPLICATIONS: Palliative care
Based on change in dyspnea from baseline, no statistically significant difference existed with opioids across seven studies. This evidence showed high heterogeneity and low overall quality. A comparison of post-treatment dyspnea scores in 11 studies showed significant benefit with opioids (standard mean difference [SMD] = –0.28, 95% confidence interval [CI] [–0.5, –0.05], p = 0.02). No significant effects (two studies) existed for nebulized opioids. Six studies were of patients with cancer. A few studies evaluated breathlessness in terms of exercise tolerance only.
The findings show that oral opioids have some benefit for the relief of dyspnea and may have some benefit for short-term improvement in exercise capacity.
Oral opioids are of benefit for reducing dyspnea. Nebulized opioids were not shown to be effective.
Barish, C.F., Drossman, D., Johanson, J.F., & Ueno, R. (2010). Efficacy and safety of lubiprostone in patients with chronic constipation. Digestive Diseases and Sciences, 55, 1090–1097.
To assess the efficacy and safety of lubiprostone in the treatment of patients with chronic constipation.
Patients had a washout period, followed by a two-week prerandomization period. Patients were randomized to receive either oral lubiprostone 24-mcg capsules (n = 119) or placebo (n = 118) twice daily with food and at least 8 oz of water. Patients were instructed to keep daily diaries to record their medication administration, use of medication rescues, and occurrences of bowel movements (BMs) (date and time). Study assessments were scheduled after one week (office visits), two weeks (telephone evaluation), four weeks (end-of-treatment office visit), and two weeks following the end of treatment.
This was a randomized, double-blinded, placebo-controlled study.
Lubiprostone was an effective treatment for chronic constipation.
Lubiprostone has been shown to be effective in the management of chronic constipation and is used for patients with chronic constipation related to irritable bowel syndrome. However, additional studies are warranted in patients with cancer, as well as the palliative care population, in which patients are receiving chemotherapy agents, antiemetics, and narcotics that contribute to their constipation.
Bardy, J., Molassiotis, A., Ryder, W.D., Mais, K., Sykes, A., Yap, B., … Lee, L. (2011). A double-blind, placebo-controlled, randomised trial of active manuka honey and standard oral care for radiation-induced oral mucositis. The British Journal of Oral & Maxillofacial Surgery, 50(3), 221–226.
To assess the effect of active manuka honey on the grade and duration of mucositis
Patients were randomly allocated by a computer-generated list of random numbers to be given active manuka honey or placebo (golden syrup) mixed with 2% sodium alginate, which increased the contact time by ensuring that the substance adhered sufficiently to the oral and oropharyngeal mucosa. They were shown the technique and given verbal and written instructions to rinse the mouth with 20 ml of the allocated substance and to swallow it slowly, 4 times per day for the duration of the radiotherapy (4 weeks) and for 2 weeks after treatment (42 days in total). To assess compliance, they were also asked to record daily on a card when they took the substance.
The patients were all to receive 4 weeks (20 fractions) of accelerated radiotherapy at a dose between 50 and 55 Gy. Synchronous or induction chemotherapy, or both, was permitted.
Since both substances in the study are known to be cariogenic in patients being treated by radiotherapy, all patients were seen by the hospital dentist before beginning treatment and were provided with fluoride toothpaste and a soft toothbrush and given written and verbal dental hygiene instructions.
Inter-rater reliability was measured between assessors and found to be higher using the modified scale.
Weekly assessments of mucositis were undertaken during radiotherapy (four weeks) and every two weeks thereafter until the mucositis resolved. Weight was assessed at each assessment.
Swabs were taken from the throat to assess for bacterial and fungal infections. These were taken at baseline and during and after radiotherapy, and the process was overseen by a microbiologist consultant.
Patients were recruited from an outpatient clinic at a cancer center in northwest England.
Patients were undergoing the active treatment phase of care.
This was a double-blind, randomized, controlled study. The treatment allocation was by minimization with an allocation probability of 2/3 to the arm that would yield a lower imbalance score.
A modified acute radiation toxicity scale of mucositis by the Radiation Therapy Oncology Group was used.
Primary analysis revealed no significant differences in the incidence of grade 3 mucositis or severity or duration of mucositis between the two groups.
Ninety-eight percent of the patients managed at least 1 week of the intervention, and 67 patients managed more than 2 weeks. Median compliance was 2 weeks for both groups.
The incidence of pathogenic bacteria in both arms was similar to reported baseline values, which indicated that the levels of bacterial colonization were similar to those of an unirradiated mouth. It also confirms the previous findings that honey has a bacteriostatic effect, which might be the result of its hyperosmolar properties, as golden syrup had a similar effect.
No significant differences were found in either the primary or the secondary outcome measures when honey was compared with placebo. The results of the study did not agree with the findings of other trials.
Well-documented bacteriostatic properties of honey exist; further research needs to be done to determine feasibility in the realm of preventing oral mucositis.
Bardia, A., Barton, D.L., Prokop, L.J., Bauer, B.A., & Moynihan, T.J. (2006). Efficacy of complementary and alternative medicine therapies in relieving cancer pain: A systematic review. Journal of Clinical Oncology, 24, 5457–5464.
To evaluate the efficacy of various complementary and alternative medicine (CAM) therapies to reduce cancer pain
The type of article is systematic review.
The initial search identified 101 articles, of which investigators excluded 85. Investigators included an additional two articles, which were found through manual scans of reference lists. Investigators appraised articles by using the Jadad scale.
The result of this systematic review was that none of these interventions can be recommended as effective. The most promising therapies appear to be mind-body interventions. In particular, hypnosis and relaxation might have some effect in decreasing cancer pain. Effect may be limited by cognitive impairment caused by cancer or cancer treatment. Support groups may have some positive effects. Whether these benefits are due to increased patient awareness, with more frequent visits to care providers, better compliance with medication regimens, or as a result of group interaction and social or emotional support is unclear. One study found that benefit occurred only in those patients who were more distressed at baseline. It is possible that effect sizes of therapies may be more discernible among patients with higher pain ratings, demonstrating a floor effect related to the symptom of pain.
Current evidence does not support the efficacy of the cited CAM interventions in the management of pain of patients with cancer. Methodologically strong research that incorporates appropriate attentional and sham controls, sufficient sample sizes, and longer duration of follow-up is needed.
Bardellini, E., Amadori, F., Schumacher, R.F., D'Ippolito, C., Porta, F., & Majorana, A. (2016). Efficacy of a solution composed by verbascoside, polyvinylpyrrolidone (PVP) and sodium hyaluronate in the treatment of chemotherapy-induced oral mucositis in children with acute lymphoblastic leukemia. Journal of Pediatric Hematology/Oncology, 38, 559–562.
To determine the efficacy of a mouthwash solution composed of verbascoside, polyvinylpyrrolidone, and sodium haluronate (Mucosyte) in the treatment of chemotherapy-induced oral mucositis (OM)
Patients undergoing chemotherapy for acute lymphoblastic leukemia (ALL) on the same protocol treatment (ALL 2009 standard protocol) were included in the study. Patients were randomized to either the group A (intervention group) or group B (placebo group). Each group were to rinse with 15 ml of the solution for two minutes three times a day for a total of eight days. OM scoring was conducted on day 1 (day of diagnosis of OM), three days after treatment, and again on day 8. Pain scores were determined at the same time as the oral examination for the OM scoring.
Randomized, double-blinded study. Each participant was randomized with an automatically generated list.
Group A showed a reduction in OM of T1 on day 3. On day 8, group A and group B had a reduction of T2, with group A revealing a statistically significant decline compared to group B (p = 0.0038). Group A showed a reduction in pain scores for both TI and T2, resulting in a reduction in additional analgesia needed, compared to group B.
The use of Mucosyte mouthwash in children with chemotherapy-induced OM revealed a reduction in the grade of OM and pain scores during an eight-day treatment and, therefore, may be recommended as a supportive treatment.
Small sample (< 100)
The implications of this study are promising for treatment with Mucosyte mouthwash for reducing OM and pain during chemotherapy for ALL. More studies may need to be conducted, because this study took into account only patients on the same treatment regimen. Other treatment regimens including chemotherapy, radiation, and or laser therapy may affect the severity and duration of OM and, therefore, may reveal different results.
Barclay, J., Vestey, J., Lambert, A., & Balmer, C. (2006). Reducing the symptoms of lymphoedema: Is there a role for aromatherapy? European Journal of Oncology Nursing, 10(2), 140–149.
To assess the effectiveness of self-massage and skin care using a base cream containing aromatherapy oils versus using a base cream without aromatherapy oils in terms of objective reduction in limb volume and patient-reported symptom improvement and well-being after simple lymphatic drainage
Self-massage and skin care significantly improved patient-identified symptom relief and well-being for patients. It also, but not significantly, reduced limb volume. Aromatherapy oils did not appear to influence any improvement in these measures. In the experimental group, 69% had limb reduction, compared to 57% in the control group (p = 0.38). Both groups combined showed slight improvement (p = 0.034). The finding supports the use of simple lymphatic drainage. Well-being, pain, discomfort, mobility, and body image were evaluated and showed significant improvement in patient-identified symptom relief and well-being. No difference was observed using aromatherapy.
Barber, C., Powell, R., Ellis, A., & Hewett, J. (2007). Comparing pain control and ability to eat and drink with standard therapy vs. Gelclair: A preliminary, double centre, randomised controlled trial on patients with radiotherapy-induced oral mucositis. Supportive Care in Cancer, 15(4), 427–440.
RCT was designed to evaluate pain control and the ability to eat and drink using standard therapy (sucralfate and Mucaine® [Wyeth-Ayerst Laboratories]) versus Gelclair® (EKR Therapeutics, Inc.) in patients with radiotherapy-induced oral mucositis.
Patients used medication 30 minutes to 1 hour before eating or drinking.
Gelclair: Patients used undiluted or could mix a single dose in a glass with up to 40 ml of water. Patients swished and gargled for at least one minute to coat the tongue, roof of mouth, throat, and inside of cheeks. If unable to do that, patients used sponge applicators. Patients spat the product out and did not swallow it.
Sucralfate and Mucaine: Patients swished 10 ml in mouth for at least 1 minute to coat all areas, then swallowed the product.
Study was 24 hours only. Baseline was 1, 3, and 24 hours after initiation of treatment.
Patients in both groups had additional analgesia available throughout the trial.
Patients swallowed standard therapy but not Gelclair.
The sample was comprised of 20 patients (n = 10 in the Gelclair group and n = 10 in the standard [sucralfate and Mucaine] group).
Patients with head and neck cancer received daily radation therapy over a 4–6 week period and showed at least grade 1 oral mucositis and pain not alleviated by paracetamol, co-codamol, or aspirin.
The mean age was 61.1 years (range = 28-79 years).
Three patients were smokers.
Double-center, prospective RCT
Single blind trial with the administrating nurse specialist unaware of medication used
Conducted as feasibility study for future sample size calculation
Oral mucositis NCI-CTC for radiation
General pain and pain on speaking VAS 0–10
Swallowing assessment was self-recorded (normal to swallowing own saliva only).
Compliance was queried by the researcher.
Using NCI grading, nine patients had grade 3 or 4 (three in the intervention arm and six in the control arm). The remaining 11 patients had grade 1 or 2 (seven in the Gelclair group and four in the standard therapy group).
No observations of relevance with regard to general pain, pain on speaking, or ability to eat and drink for those with higher grades of oral mucositis.
Number of coanalgesics of strong opiate type
One patient was noncompliant for sucralfate and Mucaine.
General pain: No significant difference was observed between the intervention and the control group across time intervals (p = 0.236).
Reduction in pain on speaking was not significant (p = 0.616).
Swallow: Effects of standard therapy appeared to last longer than Gelclair (NS).
Because the study was only 24 hours, effectiveness with more severe mucositis is not known.
Barber, F.D. (2013). Effects of social support on physical activity, self-efficacy, and quality of life in adult cancer survivors and their caregivers. Oncology Nursing Forum, 40, 481–489.
To explore the relationships between adult cancer survivors’ and caregivers’ social support, self-efficacy for physical activity, physical activity, and quality of life, and to understand their perceptions of social support in physical activity participation
Participants attended the FitSTEPS for Life® (FSFL) for one month. FSFL is an individually tailored and supervised community-based exercise program for cancer survivors and their caregivers established by the Cancer-Foundation For Life nonprofit organization. Survivors required a referral from their oncologists to be able to attend FSFL and were expected to exercise at least three times a week.
Only data on caregivers were included in this summary.
Mixed-method, quasi-experimental study with written responses to questions and recorded interviews of the caregivers of patients who enrolled in FSFL based on oncologist referrals
Participation in FSLP did not have a significant effect on caregivers' PA, quality of life, social support, or SEPA. Qualitative data supported relationships between social support, PA, and quality of life.
Nurses should consider the role of social support in designing interventions to influence the PA, self efficacy, and quality of life of caregivers. Nurses should encourage cancer survivors and their caregivers to openly discuss their needs for social support. This study was too small to evaluate the effects of exercise, and the high drop out rate suggests that continued involvement in this type of effort may not be acceptable for patients and caregivers.
Bar-Sela, G., Atid, L., Danos, S., Gabay, N., & Epelbaum, R. (2007). Art therapy improved depression and influenced fatigue levels in cancer patients on chemotherapy. Psycho-Oncology, 16, 980–984.
The intervention consisted of once weekly art therapy sessions to teach patients to act in a more conscious way by painting with water-based paints. The intervention was provided by an art therapist. The duration of the sessions varied. Those who completed four or more sessions (n = 19) were compared to those who participated for two weeks or less (n = 41).
The study was conducted in an ambulatory setting of a cancer center in northern Israel.
The study used a single-arm, open-label design.
For treatment with art therapy, a patient requires referral to an art therapist.
Bar-Sela, G., Atid, L., Danos, S., Gabay, N., & Epelbaum, R. (2007). Art therapy improved depression and influenced fatigue levels in cancer patients on chemotherapy. Psycho-Oncology, 16, 980–984.
An anthroposophy art therapy intervention (watercolor painting) in weekly group sessions was administered by an art therapist in northern Israel. Participants chose the amount of time to spend in the session, ranging from a few minutes to more than an hour. Data were collected at baseline and before every session.
A single-arm, pilot study design was used.
A Mann-Whitney U test compared HADS and BFI in the intervention group and the participation group. A Wilcoxon signed-rank test assessed changes in HADS and BFI scores in the two groups. There were no significant difference between the two groups for reducing anxiety (p = 0.2).