Bonfili, P., Gravina, G.L., Marampon, F., Rughetti, A., Di Staso, M., Dell'Orso, L., . . . Di Cesare, E. (2015). Oral platelet gel supernatant plus supportive medical treatment versus supportive medical treatment in the management of radiation-induced oral mucositis: A matched explorative active control trial by propensity analysis. American Journal of Clinical Oncology. Advance online publication.
To examine the use of oral platelet gel supernatant with supportive medical treatment versus supportive medical treatment alone in the management of radiation-induced oral mucositis (OM) in patients with head and neck cancer
The intervention group was a prospective sample of patients receiving treatment for head and neck cancer, and controls were historical controls. The intervention and control groups received supportive measures maintaining adequate hydration, nutritional status, and oral hygiene, including mild-flavored toothpaste, saline peroxide mouthwash three to four times a day, and an antifungal agent. The intervention group also received platelet gel supernatant (PGS) three times per day one hour before breakfast, lunch, and dinner. PGS treatment was started on the first day of radiation or chemoradiation treatment and stopped at the end of the radiation course. Patients were monitored during treatment and as many as seven weeks after treatment completion. OM was assessed by two radiation oncologists.
Quasi-experimental
The intervention group experienced a decrease in the severity of WHO grade 3 and 4 toxicity that was statistically significant (p = 0.0074). The intervention group also showed a later onset of mucositis based on the WHO grade toxicity and higher quality of life as measured by OMQ-HN (p = 0.001). A greater decrease in the use of opioid analgesics was found in the intervention group (p = 0.0021) compared to the control group.
A decrease in WHO grades 3 and 4 toxicity and a slower symptom onset was demonstrated with PGS administration.
PGS in combination with supportive therapy is potentially beneficial in the management of radiation-induced OM. The intervention was aimed at affecting OM. Using the WHO grading scale, a delay in OM development was seen; however, some patients did not receive chemotherapy, and certain drugs exacerbate OM. Additional studies in in populations receiving radiation and chemotherapy are needed.
Boneti, C., Badgwell, B., Robertson, Y., Korourian, S., Adkins, L., & Klimberg, V. (2012). Axillary reverse mapping (ARM): Initial results of phase II trial in preventing lymphedema after lymphadenectomy. Minerva Ginecologica, 64, 421–430.
To evaluate lymphedema rates when axillary reverse mapping (ARM) is added to lymphadenectomy
After sentinel lymph node localization, ARM was performed by injecting blue dye subcutaneously to localize lymphatics draining the arm. Standard level I and II lymph node dissection was done to include blue lymph nodes as appropriate. Otherwise, blue nodes were preserved. Average follow-up was 14.6 ± 9.4 months.
This was a single-site study conducted in Arkansas.
Patients were undergoing the active antitumor treatment phase of care.
This was an bservational, descriptive study.
Arm volume was measured; the method of measurement was not described.
Almost a third (30%) of patients had axillary staging done prior to neoadjuvant chemotherapy; the remaining patients had the ARM procedure done during their definitive surgical treatment. Overall incidence of lymphedema when the ARM node was preserved was 2.9% compared to 18.7% in patients who had ARM lymphatics resected.
Findings suggest that ARM with preservation of lymph nodes when possible can result in lower incidence of lymphedema.
Findings suggest that the addition of ARM to standard surgical procedures might enable preservation of some lymph nodes with resulting lowered prevalence of lymphedema in patients with breast cancer. This study provides minimal support because of study design and limitations. Long-term effects of lymph node preservation need to be explored.
Bolderston, A., Lloyd, N.S., Wong, R.K.S., Holden, L., Robb-Blenderman, L., & Supportive Care Guidelines Group. (2005). The prevention and management of acute skin reactions related to radiation therapy: A clinical practice guideline (Practice Guidelines Report #13-7). Toronto, Canada: Cancer Care Ontario. Retrieved from https://www.cancercare.on.ca/common/pages/UserFile.aspx?fileId=34406.
To develop practice guidelines answering two questions:
Databases searched were PreMEDLINE, MEDLINE, CANCERLIT, and Cochrane Library between January 1980 and April 2004. The name of the initiative was the Cancer Care Ontario’s Program in Evidence-Based Care. The method used was the practice guidelines development cycle. Articles were included based on rigorous inclusion criteria (meta-analysis, systematic reviews, evidence-based practice guidelines, comparative studies, prospectively collected data in at least one trial arm, studies with reported outcomes—degree of skin reaction [using a validated skin reaction tool] and other outcomes reported and articles available as published articles or abstract reports). Exclusion criteria were also identified.
The systematic review included interprofessional members from the Supportive Care Guidelines Group of Cancer Care Ontario and the Program in Evidence-Based Care, an internationally recognized program at McMaster University, Hamilton, Ontario, Canada.
No conflict of interest was identified.
A systematic review of 28 clinical trials was included in analyses; 23 pertained to prevention and 5 addressed management of skin reactions. Two practice guides were reviewed: Oncology Nursing Society and British Columbia Cancer Agency (expert opinion and consensus).
A table of clinical studies presented study descriptions and outcomes of the trials on prevention and management of skin reactions, pain, and itching.
The largest randomized trial compared calendula versus Biafine and was significant (p = 0.03) in reducing the severity of RT dermatitis.
Insufficient evidence existed to support or refute the use of
•Topical agents (corticosteroids, sucralfate cream, Biafine® (Ortho Dermatologics), ascorbic acid, aloe vera, chamomile cream, almond ointment, or polymer adhesive skin sealant)
•Oral agents (enzymes, sucralfate)
•Intravenous agents (amifostine)
Gentle skin and hair washing should be unrestricted in patients receiving RT. No barrier exists to using mild soap.
No trials answered the question on management.
Future Research:
Opinions of This Group:
Bokmand, S., & Flyger, H. (2013). Acupuncture relieves menopausal discomfort in breast cancer patients: A prospective, double blinded, randomized study. The Breast, 22, 320–323.
To investigate the therapeutic effect of acupuncture on hot flashes and disturbed sleep in patients with breast cancer, the possible side effects of this treatment, and the effect on plasma estradiol levels
Two experienced acupuncturists provided either true acupuncture or sham acupuncture in the predetermined points. Group 1 had manual acupuncture in pre-determined bilateral points for 15–20 minutes once a week for five consecutive weeks. These points were Hc6, Ki3, Sp6, and Lr3, which are located on the wrist, ankle, and foot. Group 2 had sham acupuncture in four predetermined bilateral non-acupuncture points outside the meridian but within the same region as the true points. The treatment was given once a week for five weeks. Group 3 received no acupuncture. All groups completed a log book. Plasma estradiol levels were measured in blood samples obtained just prior to the first treatment and 30 minutes after. It was measured again at five weeks later and 30 minutes after the final treatment. Group 3 had plasma estradiol levels obtained at allocation and five weeks later.
The researchers reported that a significant relief occurred in the acupuncture group after the second treatment, lasting until 6 weeks post-treatment (p < 0.05), as compared to the sham acupuncture and no treatment groups, which lasted for at least 12 weeks. A decrease in sleep disturbance also was noted in the same group as compared to the others. Side effects were reported as mild and temporary. Reported side effects included fatigue, pruritus, and nausea. No effect on the plasma estradiol levels in all groups occurred. Eleven women from all groups reported using concurrent treatments including clonidine and/or venlafaxine, mirtazapine with clonidine, and hormone replacement.
The acupuncture group reported a decrease in hot flashes versus the other groups. No formal validation of the visual analog scale occurred. The concurrent use of other therapies may influence the reported outcomes. Restrictions of concurrent therapies for hot flashes during participation and validation of the self-reporting tool were needed.
A large randomized trial exploring acupuncture versus placebo is needed that restricts concurrent therapy usage during trial participation and includes women with breast cancer having similar hot flash interventions such as tamoxifen or aromatase inhibitors with hot flash occurrence. True acupuncture may benefit, but further study is indicated.
Bohlius, J., Herbst, C., Reiser, M., Schwarzer, G., & Engert, A. (2008). Granulopoiesis-stimulating factors to prevent adverse effects in the treatment of malignant lymphoma. Cochrane Database of Systematic Reviews, 4, CD003189.
The purpose of this study was to determine the effectiveness of G-CSF and GM-CSF in patients with malignant lymphomas for improving overall survival (OS) and freedom from treatment failure (FFTF). Secondary goals were to to decrease the risk and duration of neutropenia and febrile neutropenia, infection and mortality during chemotherapy; improve received dose intensity, tumor response, and quality of life; and examine adverse effects.
Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CancerLit, Medikat, Russmed Articles, SOMED, Toxline, BIOSIS Previews, and LILACS databases were used.
In addition, Internet databases of grey literature (SIGLE) and ongoing trials were reviewed, as were conference proceedings. Experts and pharmaceutical companies also were contacted for unpublished or ongoing trials. Citations of identified trials also were searched.
Key words included granulocyte–colony-stimulate factor (G-CSF), granulocyte-macrophage–colony-stimulating factor (GM-CSF), malignant lymphoma
Studies were included if they were randomized, controlled trials (RTCs) conducted from January 1980 to April, 2008 comparing G-CSF or GM-CSF prophylaxis with placebo or no prophylaxis; studies on long-lasting G-CSFs (e.g., filgrastim) also were included. Abstracts and unpublished data were included if enough data were available on study design, patient characteristics, interventions, and outcomes.
Studies were excluded if they were crossover studies, quasi-randomisedand, or nonrandomised comparative studies.
306 total abstracts were reviewed. Of these, 90 studies were evaluated and 74 excluded for not meeting inclusion criteria. The remaining 16 RTCs met inclusion criteria, but three of these were later excluded due to not fulfilling all criteria.
Subgroup analysis and investigation of heterogeneity (drug type: G-CSF versus GM-CSF; Hodgkin disease versus non-Hodgkin lymphoma; age [trials that included all ages 16 and older versus those restricted to older than age 60 years]; administration of prophylactic antibiotics during chemotherapy; different toxicity of chemotherapies); sensitivity analysis (placebo-controlled versus open label; concealment of allocation; size of studies [less than 100 versus 100 or greater]; published versus unpublished, unreported, or abstract based; and duration of follow-up). Statistical analyses included hazard ratios (OS and FFTF) (missing patient data analyzed using published survival curve methods); relative risk and 95% confidence interval (CI) (binary data) using the Mantel-Haenszel method for pooling (pooled using a fixed effect model); continuous data calculated as weighted mean differences with 95% CI; heterogeneity of treatment effect via chi-squared (p < 0.05); robustness of overall results and causes of heterogeneity assessed by sensitivity and subgroup analyses; funnel plots and linear regression (for bias; 0.1 = significant) used for meta-analyses of four or more trials; all data based on intention-to-treat or full set analysis.
The prophylactic use of G-CSF or GM-CSF in patients aged 16 years and older with malignant lymphomas who underwent standard chemotherapy treatment had a reduced risk of neutropenia, febrile neutropenia, and infections. The prophylactic use of G-CSF or GM-CSF in this patient population does not increase overall survival or freedom from treatment failure.
Since neutropenia, febrile neutropenia, and infections are prevalent among patients with malignant lymphomas being treated with chemotherapeutic agents, the prophylactic use of G-CSF and GM-CSF is warranted to decrease the risk of these deleterious treatment effects.
Implications for nursing practice include knowledge about the efficacy of using these growth factors, advocating for their use, and close patient monitoring.
Bohlius, J., Tonia, T., Nuesch, E., Juni, P., Fey, M.F., Egger, M., & Bernhard, J. (2014). Effects of erythropoiesis-stimulating agents on fatigue- and anaemia-related symptoms in cancer patients: Systematic review and meta-analyses of published and unpublished data. British Journal of Cancer, 111, 33–45.
PHASE OF CARE: Active antitumor treatment
APPLICATIONS: Elder care, palliative care
Societies in the United States and Europe continue to have different recommendations regarding the use of ESAs during cancer treatment; for QoL in palliative settings, the harmful effects of ESAs should be balanced against potential benefits. There is no evidence to support their use in managing cancer-related fatigue.
Greater than 90% of the studies were funded by pharmaceutical companies.
For patients receiving palliative care, there may be a role for ESAs in reducing transfusion use; there does not appear to be any role for ESAs in managing cancer-related fatigue.
Boesen, E. H., Ross, L., Frederiksen, K., Thomsen, B. L., Dahlstrøm, K., Schmidt, G., . . . Johansen, C. (2005). Psychoeducational intervention for patients with cutaneous malignant melanoma: a replication study. Journal of Clinical Oncology, 23, 1270–1277.
A psychoeducational intervention was offered between three weeks and four months postsurgery for malignant melanoma to groups of 8 to 10 patients. The intervention was organized into six sessions lasting approximately 2.5 hours each and was performed over a six-week period. The intervention consisted of health education about malignant melanoma and follow-up routines, the importance of limiting sun exposure, stress awareness, and stress management (relaxation and guided imagery). Patients were given a workbook and a CD with relaxation and imagery exercises. Psychological support was provided via the presence of a group therapist throughout all sessions and through peer support in the group setting.
Patients were undergoing the long-term follow-up phase of care.
The study was a randomized, controlled trial with a usual care control group. Fatigue was evaluated at baseline prior to the intervention and at 6 and 12 months postintervention.
Profile of Mood States (POMS)
Controlling for baseline levels of fatigue, there was a statistically significant effect of the intervention on fatigue six months postintervention. This effect was not sustained at 12-month follow-up. Sixteen patients dropped out of the intervention before it started or after one session. All patients who dropped out cited that they dropped out due to the time or the distance involved or that they felt no need for support.
Efficiencies of treatment were achieved through the group intervention modality.
Boesen, E.H., Karlsen, R., Christensen, J., Paaschburg, B., Nielsen, D., Bloch, I.S., . . . Johansen, C. (2011). Psychosocial group intervention for patients with primary breast cancer: A randomised trial. European Journal of Cancer, 47, 1363–1372.
To test the effects of a group cognitive behavioral therapy (CBT) intervention on psychosocial symptoms in women with breast cancer
One to two weeks after surgery, women who agreed to participate were randomly assigned to a psychosocial intervention or a usual-care control group. The intervention consisted of 12 hours of education over a two-week period. Education provided information about treatment modalities, side effects, social rights, healthful diet, stress management, cognitive reframing, and sexuality issues. The intervention then involved meetings of eight women. Each group met weekly, in a 2.5-hour session, for eight weeks. In the sessions, the women shared experiences to reveal negative thinking and integrate the elements of cognitive therapy. Follow-up was up at 1, 6, and 12 months.
Randomized controlled trial
At no time in the study did differences exist between groups in regard to mood disturbances, quality of life, or marital relationships.
The psychosocial intervention, consisting of cognitive behavioral techniques, had no effect on depression, anxiety, quality of life, or marital relationship.
The CBT intervention tested had no observable effect on depression or anxiety in women with breast cancer.
Boele, F.W., Douw, L., de Groot, M., van Thuijl, H.F., Cleijne, W., Heimans, J.J., . . . Klein, M. (2013). The effect of modafinil on fatigue, cognitive functioning, and mood in primary brain tumor patients: A multicenter randomized controlled trial. Neuro-Oncology, 15, 1420–1428.
To investigate the effects of modafinil on fatigue, depression, cognitive impairment, and health-related quality of life in patients with primary brain tumors
The intervention consisted of subjects receiving modafinil versus a placebo over six weeks. The week 1 dosage was 100 mg twice daily and the weeks 2–6 dosages were 200 mg twice daily. The cross-over occurred after the completion of week 6; thus, subjects who initially received the placebo followed the same dosing schedule over the next six weeks while those who had taken modafinil previously were given a placebo. Neuropsychological assessments and self-report measures were completed at baseline, six weeks, and 12 weeks.
PHASE OF CARE: Multiple phases of care
Randomized, controlled, double-blinded clinical trial using a cross-over design. Measurements were performed at baseline, six weeks, and 12 weeks.
The CIS severity and reduced motivation scores for fatigue were lower after treatment with both modafinil (p = 0.01, p = 0.021) and placebo arms (p < 0.001, p = 0.027), but there was no difference in scores between trial arms. Significant improvements in working memory (p = 0.04, p = 0.043), information-processing (p = 0.036, p = 0.04), and attention (p = 0.015, p = 0.013) were found after treatment with modafinil and the placebo, respectively. There were no differences in scores between trial arms. Health-related quality of life measured by the physical component summary of the SF-36 was significantly improved for both modafinil (p = 0.001) and placebo arms (p = 0.008). There were no differences in depressive symptoms following modafinil or placebo.
The results indicate that there were no significant differences observed in fatigue, cognitive functioning, health-related quality of life, and mood between modafinil and a placebo. These findings may be related to the study design, duration of treatment, low study accrual, subject withdrawals, and lack of longitudinal follow-up.
Findings do not support the use of modafinil to improve fatigue, cognitive functioning, mood, and health-related quality of life in patients with brain tumors.
Boele, F.W., Hoeben, W., Hilverda, K., Lenting, J., Calis, A.L., Sizoo, E.M., . . . Klein, M. (2013). Enhancing quality of life and mastery of informal caregivers of high-grade glioma patients: A randomized controlled trial. Journal of Neuro-Oncology, 111, 303–311.
To determine factors that impact health-related quality of life (HRQOL) and mastery of caregivers of patients with high-grade glioma, and to investigate if a structured intervention consisting of psycho-education and cognitive behavioral therapy (CBT) leads to an improvement in the mental component of HRQOL and mastery of caregivers
Caregiver dyads randomly were assigned to the intervention group or care as usual group. The intervention group consisted of six one-hour sessions with a psychologist for CBT and psycho-education regarding disease-specific symptoms. Participants completed questionnaires concerning their perception of the patients' HRQOL, neurologic functioning, cognitive functioning, their own HRQOL perceptions, and feelings of caregiver mastery at baseline (prior to randomization) and every two months thereafter until eight months later, five times total.
Caregivers' HRQOL and caregiver mastery were associated with patient-related factors at baseline. A positive correlation was found between a positive mental functioning (MCS) of the patient and a positive MCS of the caregiver. Feelings of mastery in the intervention group increased over time, while feelings of mastery in the control group showed the opposite pattern. Those who received the intervention maintained a more stable level of mental functioning and showed modest improvement in feelings of mastery in comparison to the control group. Patients' HRQOL and neurologic functioning were found to be related to HRQOL and feelings of mastery of the informal caregiver at baseline. The intervention helped caregivers in maintaining a stable level of HRQOL and improved feelings of mastery over an eight-month period.
The findings from this RCT suggest that informal caregivers can benefit from a psychological CBT intervention because it is a helpful tool in maintaining a stable level of mental functioning and caregiver mastery.
Future nursing practice should focus on offering supportive interventions to patients with high-grade glioma and their informal caregivers. Further research should continue to look at the effects of a psychological intervention on HRQOL and feelings of mastery of informal caregivers of the high-grade glioma patient population. Findings suggest that CBT interventions can be of benefit to caregivers.