Hadjieva, T., Cavallin-Stahl, E., Linden, M., & Tiberg, F. (2014). Treatment of oral mucositis pain following radiation therapy for head-and-neck cancer using a bioadhesive barrier-forming lipid solution. Supportive Care in Cancer, 22, 1557–1562.
To test the analgesic effect of CAM2028 with benzydamine compared with CAM2028 without benzydamine (the FDA-approved prescription formula of episil) over an eight-hour period. During treatment with CAM2028, phospholipid and triglceride lipid components self-assemble with a volume of water (saliva) to form a bioadhesive and protective liquid crystalline lining of the oral mucosa. Additional objective of the study was to assess the safety and tolerability of a single-dose of the combined formulation.
Crossover, double-blind, placebo-controlled, single-dose, randomized, proof of concept trial
All patients completed the trial. With both treatments, patients experienced a mean 40% decrease in pain intensity at six hours. Both treatments resulted in significant pain relief within five minutes of application that was evident during the entire eight-hour assessment period. At no time did mean pain ratings or pain intensity difference differ statistically between the two treatments. The mean AUC of pain intensity over time did not differ between the two treatments. All of the analyses of pain intensity outcomes showed a statistically significant clinical center effect, with one center reporting larger pain intensity difference values than others. No reason was offered for this difference.
The similar treatment effects of CAM2028 with or without benzydamine suggest that benzydamine did not contribute additionally to the reduction of oral mucositis pain compared with the unmedicated CAM2028 control. CAM2028 resulted in immediate and significant pain relief with a duration that was maintained for up to eight hours.
Haddad, N.E., & Palesh, O. (2014). Acupuncture in the treatment of cancer-related psychological symptoms. Integrative Cancer Therapies, 13, 371–385.
PHASE OF CARE: Multiple phases of care
APPLICATIONS: Elder care
The studies included 11 quantitative and one qualitative study. Their findings showed positive effects on sleep in two studies, one of which was a single-arm, nonrandomized study. Positive effects were shown on anxiety in three studies, one of which was single-arm. Four studies showed positive effects on depression, one of which was single-arm. Five studies did not show acupuncture to have any effects. It was noted that acupuncture methodology was inconsistently reported. There also was a lack of data such as standard deviations and change scores.
This review showed mixed results for the effects of acupuncture on sleep, depression, and anxiety. The current evidence has several study design and reporting limitations.
There is no strong evidence to support the use of acupuncture for the treatment of anxiety, depression, or sleep disturbances.
Hacking, B., Wallace, L., Scott, S., Kosmala-Anderson, J., Belkora, J., & McNeill, A. (2013). Testing the feasibility, acceptability and effectiveness of a 'decision navigation' intervention for early stage prostate cancer patients in Scotland: A randomised controlled trial. Psycho-Oncology, 22, 1017–1024.
To determine if decision-making support (called decision navigation) was feasible, acceptable, and effective among patients newly diagnosed with prostate cancer with the aim of evaluating confidence in making treatment decisions, certainty in decisions made, and changes in mood and adjustment
Decision navigation involved two primary components, a list of questions to support the question and answer process and audio recordings and summaries to improve information recall.
Randomized, controlled trial
The intervention was not shown to have an impact on anxiety or depression symptom scores.
Dedicated decision support for patients preparing for treatment consultation involves patients, increases confidence in asking questions during the consultation, and increases certainty about decisions made. Research to evaluate the effectiveness and cost reduction potential of DN for people with other cancer diagnoses is important. Although decision support interventions are essential to assist patients in decision making, these approaches alone may not be sufficient to manage symptoms of depression and anxiety.
Ha, K., & Choi, S. (2014). The effect of a PNF technique program after mastectomy on lymphedema patients’ depression and anxiety. Journal of Physical Therapy Science, 26, 1065–1067.
To examine the effects of exercise with proprioceptive neuromuscular facilitation (PNF) on depression and anxiety in women with postmastectomy lymphedema
Subjects performed the exercises for 30 minutes, three times weekly, for 16 weeks. Subjects were divided into three groups, a PNF plus super lizer group (which received light radiation as well), a PNF plus manual lymphatic drainage (MLD) group, and a PNF alone group. All groups received the same exercises. Study measures were obtained every four weeks.
Three-group trial with a repeated-measures design
Although there was a group-by-time interaction effect on the results, depression scores declined significantly in all groups with no significant difference between the groups after 16 weeks. Anxiety scores also declined in all groups with no differences between them. At the end of the study, scores were lowest in the PNF plus MLD group. Scores declined more in this group over time.
The findings of this study are inconclusive regarding the impact of PNF exercise on depression and anxiety in women with lymphedema following a mastectomy.
Exercise and MLD have previously been shown to be of benefit for women with lymphedema, and exercise has been shown to be beneficial in terms of reducing anxiety and depression in patients with cancer. It is not clear whether the specific PNF technique in exercise has any greater benefit. This study had several design limitations.
Gutzmer, R., Becker, J.C., Enk, A., Garbe, C., Hauschild, A., Leverkus, M., . . . Homey, B. (2011). Management of cutaneous side effects of EGFR inhibitors: Recommendations from a German expert panel for the primary treating physician. Journal der Deutschen Dermatologischen Gesellschaft, 9, 195–203.
To describe the underlying mechanisms, clinical presentation, severity grading (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 4.0), and strategies to prevent and manage epidermal growth factor receptor inhibitor (EGFRI)-associated skin side effects, emphasizing evidence-based practice.
The type of patients addressed was adults receiving an EGFRI, including monoclonal antibodies (e.g., cetuximab, panitumumab) and tyrosine kinase inhibitors (e.g., erlotinib, gefitinib, lapatinib).
In this expert opinion article, a panel of German dermatologists met in June 2009 in Frankfurt am Main, Germany, to generate mutual recommendations on the management of cutaneous side effects of EGFRIs. Those recommendations were passed after an internal revision in July 2010. The authors stated the basis of the recommendations was the physicians’ long-term personal experiences with affected patients.
Databases searched were not reported.
Search keywords were EGFR, cutaneous side effects, and papulopustular exanthema.
Studies were included in the review if they were published up to April 2010.
Exclusion criteria were not reported.
Patients were undergoing the active treatment phase of care.
General and Preventive Measures for All Patients Receiving EGFRI Therapy:
Medicinal Prophylaxis of EGFRI Cutaneous Lesions:
Therapy of the Papulopustular Exanthems on the Face and Trunk:
Advanced Diagnostics and Therapy for Rash (Usually With a Dermatologist):
Therapy of Papulopustular Exanthems on the Scalp:
Treatment Recommendations: Dry Skin and Pruritus:
Treatment Recommendations: Paronychia:
Effective management of frequent cutaneous side effects is important for tumor therapy. The present recommendations developed by a German expert panel are based on a three-step concept.
Although the article had 36 references, several interventions (especially in rash—advanced diagnostics and therapy, rash—therapy on scalp, measures for dry skin and pruritus, and therapy of paronychias) do not have a specific reference.
Adequate management of cutaneous side effects is necessary for optimal therapeutic benefit and enhanced quality of life. Because of their visibility, cutaneous side effects are experienced by many patients as a psychological burden that can impair quality of life and often endangers compliance with therapy, or leads to a dose reduction or discontinuation. This article provided nurses with practical recommendations for the prevention and management of cutaneous side effects of EGFRIs.
Gurion, R., Belnik-Plitman, Y., Gafter-Gvili, A., Paul, M., Vidal, L., Ben-Bassat, I., . . . Raanani, P. (2011). Colony-stimulating factors for prevention and treatment of infectious complications in patients with acute myelogenous leukemia. Cochrane Database of Systematic Reviews, 9, CD008238.
The purpose of the article is to assess the influence of colony-stimulating factors (CSFs) on the prevention and treatment of infectious complications in patients with acute myelogenous leukemia (AML).
The Cochrane Central Register of Controlled Trials, MEDLINE (January 1966 to July 2010), and LILACS (through December 2009) databases were searched, as were ongoing trials and conference proceedings from January 2002 to June 2010 from the European Group for Bone and Marrow Transplantation, the Annual Meeting of the European Hematology Association, the Annual Meeting of the Society for Hematology and Stem Cells, and the Center for International Blood and Marrow Transplant Research (CIBMTR).
Articles included in this review were randomized, controlled trials that compared the addition of CSFs during and following chemotherapy to chemotherapy alone in patients with AML and included age, type of AML (morphology criteria according to the FAB classification), leukemia type (de novo AML, secondary AML, refractory AML, relapsed AML), white blood cell count, platelet count, and treatment stage (induction, consolidation, relapse).
Articles were excluded if they were reporting on trials evaluating the role of CSFs administered for the purpose of stem cell collection and/or priming (e.g., before and/or only for the duration of chemotherapy).
1,421 total references were retrieved.
Following a review of each study by two reviewers, statistical analyses were conducted including relative risk with a 95% confidence interval (CI) for dichotomous data and hazard ratios for time-to-event outcome. Cochrane handbook criteria were used to assess study quality.
Active treatment
No statistically significant differences were found between patients who received CSF with chemotherapy compared to those who did not. This included no differences in 30 day all-cause mortality (RR = 0.97; 95% CI [0.8, 1.18]) and end of follow-up (RR = 1.01; 95% CI [0.98, 1.05]), overall survival (HR = 1.00; 95% CI [0.93, 1.08]), complete remission (RR = 1.03; 95% CI [0.99, 1.07]), relapse (RR = 0.97; 95% CI [0.89, 1.05]), disease-free survival (HR = 1.00; 95% CI [0.9, 1.13]), decrease in bacteremias (RR = 0.96; 95% CI [0.82, 1.12]) or invasive fungal infections (RR = 1.4; 95% CI [0.9, 2.19]). There was a slight increase in adverse events requiring discontinuation of CSFs in intervention groups compared to controls (RR = 1.33; 95% CI [1.00, 1.56]). Among 17 studies in which duration of neutropenia was reported, in all but one study the duration of neutropenia was significantly shortened with CSFs. Several studies reported a significant shortening of duration of hospital stay with CSFs, while others showed no difference.
Administration of CSFs is associated with decreased episodes of febrile neutropenia and febrile days; however, it shows no statistically significant benefit of being administered with chemotherapy for improved survival and decreased infection rates. Since hematopoiesis is different in pediatric patients compared to adults (occurring in the bone marrow of long bones and at higher rates in pediatric populations, and in flat bones at slower rates in adults and older adults), benefits may be found in older age groups when using CSF with chemotherapy. Among the studies that had a mean age of patients at 58 years and older (n = 7), six of them showed more favorable outcomes in patients who received CSF.
The composite evaluation of all age groups together.
Implications for practice based on this study are unfavorable to use CSF for decreased infection rates among all age groups. Further evaluation in older age groups may be warranted.
Gurdal, S.O., Kostanoglu, A., Cavdar, I., Ozbas, A., Cabioglu, N., Ozcinar, B., . . . Ozmen, V. (2012). Comparison of intermittent pneumatic compression with manual lymphatic drainage for treatment of breast cancer–related lymphedema. Lymphatic Research and Biology, 10(3), 129–135.
To compare the effects of complete decongestive therapy (CDT) with intermittent pneumatic compression (IPC) and self-lymphatic drainage
Patients were randomized to receive either CDT, consisting of manual lymphatic drainage and compression bandaging, or self-lymphatic drainage and pneumatic compression. Both groups did the same exercises and wore compression garments at the end of therapy. Treatments were done every other day for six weeks. IPC was applied for 45 minutes in each treatment. Patients did self drainage at home daily for 15 minutes during the study. Study measurements were done at the beginning and end of the six-week study period.
Both groups had significant reduction in arm volumes at one, two and six weeks (p < .001). There were no significant differences between the groups in this change. There were no significant differences between groups in other study measures. Quality of life improved significantly across the study in both groups.
There were no significant differences in lymphedema or associated quality of life between patients receiving CDT or IPC plus self lymphatic drainage. Both approaches were effective in reducing arm lymphedema volumes.
Findings show that both approaches studied were effective in reducing lymphedema and improving QOL over a six-week period. The study is limited by the small sample size and short period of time for follow-up.
Gupta, S., Singh, P.K., Bhatt, M.L., Pant, M.C., Gupta, R., & Negi, M.P. (2010). Efficacy of granulocyte colony stimulating factor as a secondary prophylaxis along with full-dose chemotherapy following a prior cycle of febrile neutropenia. Bioscience Trends, 4, 273–278.
The purpose of the study was to evaluate the feasibility and efficacy of G-CSF secondary prophylaxis in patients with solid tumors undergoing chemotherapy.
Patients in the study required IV antibiotics filgrastim 300 mg per day subcutaneously starting 24–30 hours after the last chemotherapy dose in a subsequent cycle. A total of 8–9 alternate day doses were given. If no other dose limiting toxicity was seen, patients received full chemotherapy dosing with filgrastim support for following treatment cycles. Duration of hospital stay, days on antibiotic therapy, incidence of fever, time to resolve fever, dose reductions or delays, neutrophil recovery time, and incidence of adverse events were recorded. Results compared to findings in the same patients during the previous chemotherapy cycle.
Single-site location in India
Active antitumor treatment
Prospective, single group, observational study
No specific measure definitions were provided.
Neutrophil recovery time, duration of fever, duration of antibiotics and duration of hospitalization, cycle delays, and chemotherapy dose reductions declined with each course of chemotherapy. The decrease in all measures was significant across four treatment cycles (p < 0.01).
Study findings provide some support the use of colony-stimulating factor as secondary prophylaxis in patients receiving myelosuppressive chemotherapy. A number of study limitations limit the strength of these findings.
This study provides limited evidence supporting the use of colony-stimulating factors as secondary prophylaxis in patients receiving chemotherapy. CSF was given every other day in this trial, adding to the body of evidence in which the frequency of administration varies. Secondary prophylaxis can play an important role in sustaining the treatment dosages of chemotherapy cycles.
Guo, Y., Jones, D., Palmer, J.L., Forman, A., Dakhil, S.R., Velasco, M.R., . . . Fisch, M.J. (2014). Oral alpha-lipoic acid to prevent chemotherapy-induced peripheral neuropathy: A randomized, double-blind, placebo-controlled trial. Supportive Care in Cancer, 22, 1223–1231.
To test whether oral alpha-lipoic acid (ALA) could reduce the severity of peripheral neuropathy in patients receiving platinum-based chemotherapy
Prior to randomization, patients were stratified according to prior exposure to platinum-based therapy dosages. Patients were assigned to receive ALA 600 mg oral sustained-release tablets three times per day. Control patients received a matching placebo. Medications were taken continuously for 24 weeks between two days prior and four days after each dose of platinum.
Only 28% in the ALA arm and 30% in the placebo arm completed 24 weeks of the study. Most discontinued the study because of withdrawal of consent and noncompliance. Neuropathy scores increased significantly from baseline in both groups at 24 weeks (p < .001). No differences were observed in study results between groups. Authors state that attrition was not related to toxicities and that adverse events were comparable between groups.
Findings did not show a beneficial effect of ALA for prevention or reduction of peripheral neuropathy in patients receiving platinum-based chemotherapy.
Findings do not show a benefit of oral ALA for prevention of chemotherapy-induced peripheral neuropathy with platinum-based chemotherapy. Management and prevention of chemotherapy-induced peripheral neuropathy is a challenge that is generally managed by dose reduction or chemotherapy discontinuation, which can reduce effectiveness in treatment of cancer. Few approaches have shown to be effective in preventing or reducing chemotherapy-induced peripheral neuropathy. Ongoing research in this area is needed.
Guo, S.P., Wu, S.G., Zhou, J., Feng, H.X., Li, F.Y., Wu, Y.J., . . . He, Z.Y. (2014). Transdermal fentanyl for pain due to chemoradiotherapy-induced oral mucositis in nasopharyngeal cancer patients: Evaluating efficacy, safety, and improvement in quality of life. Drug Design, Development and Therapy, 8, 497.
To evaluate the safety and efficacy of transdermal fentanyl for oral mucositis pain
Transdermal fentanyl was given at a rate of 25 mcg per hour to patients with pain scores greater than five during treatment and increased by 25 mcg per hour to maintain pain scores less than or equal to three on a numeric rating scale. Study assessments were done on days 1, 4, 7, and 10. Patients rated pain daily.
PHASE OF CARE: Active antitumor treatment
Open-label, observational trial
Mean pain scores declined from 7.41 before treatment to 5.54 (SD = 0.86, p < 0.001) on day 1 and 2.82 (SD = 0.68, p < 0.001) on day 10. Sleep quality was improved after treatment (p < 0.001). The most frequent side effect was nausea and vomiting. No patients discontinued treatment.
Transdermal fentanyl was quickly effective in reducing pain from oral mucositis in this patient population. Pain reduction was associated with improved sleep.
The findings of this study demonstrated that transdermal fentanyl was effective in reducing oral mucositis-related pain within one day, and pain scores continued to decline during combined radiation and chemotherapy. They also suggested that adequate pain control in this patient population improves sleep quality and other aspects of quality of life.