Devoogdt, N., Christiaens, M.R., Geraerts, I., Truijen, S., Smeets, A., Leunen, K., . . . Van Kampen, M. (2011). Effect of manual lymph drainage in addition to guidelines and exercise therapy on arm lymphoedema related to breast cancer: randomised controlled trial. BMJ (Clinical Research Ed.), 343, d5326.
To determine the effect of manual lymph drainage (MLD) in addition to exercise compared to exercise alone for management of lymphedema in patients with breast cancer
After surgery, patients with axillary node dissection were recruited to the study and randomized to receive exercise, guidelines for self-care and MLD, or exercise and guidelines alone. MLD was begun one week after removal of axillary drains and 5 weeks after surgery and was provided for 20 weeks. All patients received the same guidelines and 30-minute individual exercise sessions. Standardized MLD sessions took half an hour, and patients received 40 treatments during the study period. Patient assessments were done at 1, 3, 6, and 12 months after surgery.
The study took place at a singe outpatient site in the Netherlands.
Patients were undergoing multiple phases of care.
The study used a single-blind randomized controlled trial design.
There were no differences between groups in incidence of arm lymphedema, time to lymphedema development, or maximal increase in arm circumference.
The addition of MLD to a program of patient guidelines and education and exercise did not have an effect on prevention of arm lymphedema in patients with breast cancer after axillary node dissection.
Findings show that the addition of MLD to a program of exercise and patient guidelines for self-management had no benefit to prevent lymphedema development.
Devine, E.C. (2003). Meta-analysis of the effect of psychoeducational interventions on pain in adults with cancer. Oncology Nursing Forum, 30(1), 75–89.
To obtain estimates of the effect of selected psychoeducational interventions on pain in patients with cancer
The search retrieved 50 studies. Authors eliminated 25 studies on the basis of inclusion and exclusion criteria. Authors did not describe the method of evaluation.
Most studies demonstrated that psychoeducational interventions had at least a small positive effect on pain in patients with cancer.
Further well-designed research in this area is needed. The complexity of cancer-related pain presents a number of challenges inherent in this research; authors outline these challenges. Psychoeducational interventions may be more acceptable to some patients than others, as high attrition rates suggest. In addition, rating pain is a subjective activity. The efficacy of an intervention may differ with cancer phase and with different pain severity. These factors should affect selection of intervention type.
Desport, J.C., Gory-Delabaere, G., Blanc-Vincent, M.P., Bachmann, P., Beal, J., Benamouzig, R., . . . Senesse, P. (2003). Standards, options and recommendations for the use of appetite stimulants in oncology (2000). British Journal of Cancer, 89(Suppl. 1), S98–S100.
To review the literature on the use of appetite stimulants in oncology by a multidisciplinary group established by the French National Federation of Cancer Centers
The group conducted a literature search of four databases (MEDLINE, CancerLit, Embase, and the Cochrane Library) using search phrases: appetite stimulants, anorexia/drug therapy, cachexia/drug, or appetite associated with neoplasms. The search yielded 55 reports of randomized controlled trials (RCTs) published between 1990–1999 that evaluated the appetite-stimulating effect of corticosteroids, synthetic progestogens, or other drugs.
The group defined standards, options, and recommendations for the use of appetite stimulants.
They also defined the level of evidence.
The primary outcome used in analysis of study results was anorexia. Secondary outcomes were improved quality of life, increase in body weight, increased food consumption, decrease in nausea and/or vomiting, and improvement in anthropometric and biologic parameters.
Corticosteroids
Corticosteroids were found to be effective appetite stimulants. Their level of evidence was B1 (good-quality evidence from randomized trials), but optimal dose and scheduling information was lacking.
Synthetic Progestogens
Megesterol acetate: Effective appetite stimulant (level B1) and beneficial effect on body weight (level B1). Minimum effective dose is 160 mg/day (level B1). Optimal dose is 480 mg/day (level C). No greater efficacy was seen with doses higher than 480 mg/day (level B1).*
Medroxyprogesterone acetate: Effective appetite stimulant (level B1). Effect on weight was not confirmed (level C). The group recommended more clinical trials to establish optimal dose and duration of therapy.
Cyproheptadine: May be an appetite stimulant, but adverse effects were reported (level C).
Dronabinol, metoclopramide, nandrolone, pentoxifylline: No appetite-stimulating effects were shown (level C). These should be used only in the setting of RCTs.
Hydrazine sulfate: Not an appetite stimulant (level A).
Corticosteroids and progestogens can be used in the treatment of anorexia in patients with cancer, especially in patients with advanced disease and with any type of cancer. Hydrazine sulfate should not be used.
* Data from trials completed after 1999 establish the safety and efficacy of higher doses of megesterol acetate.
de Souza Fêde, A. B., Bensi, C. G., Trufelli, D. C., de Oliveira Campos, M. P., Pecoroni, P. G., Ranzatti, R. P., . . . Del Giglio, A. (2007). Multivitamins do not improve radiation therapy-related fatigue: results of a double-blind randomized crossover trial. American Journal of Clinical Oncology, 30, 432–436.
Patients were randomized to two groups. Group A received the placebo for the first phase of the study and then switched to receiving multivitamins for the second phase. Group B received multivitamins for the first phase of the study and then switched to receiving placebo for the second phase. The multivitamins provided for patients were Centrum Silver tablets. To keep patients and researchers blinded, Centrum Silver tablets were crushed and offered to patients within capsules identical to those containing placebo. Randomization was centralized by a pharmacist to maintain the blinding of patients and investigators. Patient outcomes were assessed at baseline (phase I), at the time of switching (phase II), and right before the start of the last radiation treatment (phase III).
Patients were undergoing the active treatment phase of care.
This was a double-blind, randomized, crossover trial with two groups: multivitamin and placebo.
No significant changes were elicited in fatigue outcomes by the multivitamin intervention. When groups were compared at phase I, no significant differences were found in fatigue. At phase II, group A had a significantly lower rate of general and physical fatigue than group B (p = 0.035). The Chalder Fatigue Scale scores of both general and physical fatigue reflected a trend in the same direction (p = 0.048).
Deshmukh, V., Kulkarni, A., Bhargava, S., Patil, T., Ramdasi, V., Gangal, S., . . . Sardeshmukh, S. (2014). Effectiveness of combinations of Ayurvedic drugs in alleviating drug toxicity and improving quality of life of cancer patients treated with chemotherapy. Supportive Care in Cancer, 22, 3007–3015.
To assess the effectiveness of a combination of Ayurvedic drugs in alleviating cancer- and treatment-related symptoms
Patients initially were divided into two groups. Group 1 did not receive any Ayurvedic drugs. Patients in group 2 received Ayurvedic herbal combinations at various time points during chemotherapy. Within group 2, arm 1 received the same drugs and a full course of chemotherapy while arm 2 received the same drugs at the start of the sixth chemotherapy cycle and arm 3 received them after completing the sixth cycle. Treatment was continued for 16 weeks. Drugs used were maukitkyukta kamdudha (MKD) and mauktikyukta praval panchamruta (MPP) in all treatment arms. Arm 3 also received suvarnabhasmadi (SBD) according to clinician preference based on Eastern Cooperative Oncology Group scores. MKD and MPP at 250 mg each were given orally twice daily. SBD was given orally at a dose of 395 mg twice daily in cow’s ghee. Patients were followed for six months. Outcomes were measured after the first cycle of chemotherapy, after the sixth cycle of chemotherapy, and one month after the sixth cycle.
Prospective study
Patients in arm 1 of the treatment group showed the least symptom severity of all groups. However, there were no statistically significant differences between the groups in any outcome measure. Symptoms declined in all patients after the first chemotherapy cycle. There were no significant differences in other chemotherapy-related toxicities.
This study showed some interesting but insignificant differences in chemotherapy-associated symptoms between patients receiving Ayurvedic drugs throughout chemotherapy, patients receiving the experimental drugs at difference time points, and patients who did not receive any of these drugs. This study's findings did not show that Ayurvedic drugs were effective in reducing symptoms compared to controls overall. This report had numerous design and reporting limitations.
Little research has been done on the effects of Ayurvedic drug combinations among patients with cancer as a form of complementary and alternative medicine to manage treatment-related symptoms. This study did not demonstrate the efficacy of the particullar combination tested, and the study had several design and reporting flaws. Additional well-designed and clearly reported research for this type of intervention is needed to determine what role, if any, Ayurvedic drugs have for symptom management in cancer care.
Deshler, A.M., Fee-Schroeder, K.C., Dowdy, J.L., Mettler, T.A., Novotny, P., Zhao, X., et al. (2006). A patient orientation program at a comprehensive cancer center. Oncology Nursing Forum, 33, 569–578.
The intervention was a 12-minute cancer orientation program video and an orientation booklet. The video provided an overview of the cancer center, a welcome statement, an introduction to the clinic’s philosophy of care, locations of treatment centers, and identified staff members. The orientation booklet provided more detail and information about various resources and services:
Measurements done at baseline included questionnaires regarding awareness of cancer resources and services, demographic information, and state and trait anxiety. Postintervention questionnaires three weeks later measured awareness, use of and satisfaction with services and resources, and state and trait anxiety. Before their first MD appointment, patients were consented and randomized to one of four arms:
Medical oncology clinic
A randomized controlled trial design was used.
The study had a small sample size.
Desborough, M., Estcourt, L.J., Doree, C., Trivella, M., Hopewell, S., Stanworth, S.J., & Murphy, M.F. (2016). Alternatives, and adjuncts, to prophylactic platelet transfusion for people with haematological malignancies undergoing intensive chemotherapy or stem cell transplantation. Cochrane Database of Systematic Reviews, 8, CD010982.
STUDY PURPOSE: To evaluate the safety and effectiveness of adjunctive or alternative agents to platelet transfusions in patients with hematologic malignancies undergoing intensive chemotherapy or stem cell transplantation to prevent bleeding
TYPE OF STUDY: Systematic review
PHASE OF CARE: Active antitumor treatment
The authors concluded that the available evidence does not allow a determination of the effect of TPO or platelet-poor plasma on the prevention of bleeding in patients with hematologic malignancies undergoing intensive chemotherapy or stem cell transplantation. This conclusion is attributed to the quality of evidence (very low quality) and the lack of adequate power to detect a clinically significant decrease in bleeding. No trials identified which evaluated agents, such as artificial platelet substitutes, fibrinogen concentrate, recombinant activated factor VII, or desmopressin, in this population.
Sufficient, high quality evidence does not exist with which to determine the safety or efficacy of adjunctive or alternative agents to platelet transfusions in patients with hematologic malignancies undergoing intensive chemotherapy or stem cell transplantation in the prevention of bleeding.
Additional studies are needed to evaluate adjunctive or alternative agents in the prevention of bleeding. Neither TPO nor plasma-poor platelets can be substituted for platelet transfusions given the current state of knowledge.
De Sanctis, V., Bossi, P., Sanguineti, G., Trippa, F., Ferrari, D., Bacigalupo, A., . . . Lalla, R.V. (2016). Mucositis in head and neck cancer patients treated with radiotherapy and systemic therapies: Literature review and consensus statements. Critical Reviews in Oncology/Hematology, 100, 147–166.
No information is provided regarding the volume of evidence retrieved or quality ratings of studies included.
All specific interventions had either recommendations against use or no ability to provide a recommendation. Cryotherapy even with bolus 5-FU was not recommended due to lack of evidence in the setting of RT for patients with head and neck cancer. The guideline provides a listing of numerous interventions that have been examined with no recommendations for use.
This review provides a comprehensive list of interventions, none of which can be recommended for practice. This article does provide a good overview of assessment instruments and provides some information on probable risk factors.
Derry, H.M., Jaremka, L.M., Bennett, J.M., Peng, J., Andridge, R., Shapiro, C., . . . Kiecolt-Glaser, J.K. (2014). Yoga and self-reported cognitive problems in breast cancer survivors: A randomized controlled trial. Psycho-Oncology. Advance online publication.
To determine the effects of yoga on self-reported cognitive function
Certified yoga instructors led two 90-minute yoga group classes per week for 12 weeks. Each group contained 4–20 participants. Hatha yoga poses targeting relaxation, mindful breathing, chest opening, spinal extension, upper-body strength, and mobility were predetermined for each of the 24 sessions, and protocol drift was monitored. Pamphlets describing the poses from the classes and a yoga DVD were provided for home practice. Participants recorded weekly home and class time to determine dose effects. Participants who missed a class were called to improve adherence. Waitlist control participants continued regular activities and were directed not to begin yoga practice until after their final assessments. Measures were assessed before the behavioral intervention, immediately after the 12-week intervention, and three months after the intervention.
Randomized, waitlist-controlled trial
At baseline, the average self-reported cognitive impairment was slight to moderate and did not differ between groups. Overall group and group-by-time effects were found (p < .05, both). Although no differences were found immediately after the 12-week intervention, the intervention group reported significantly less cognitive impairment than controls three months after the intervention ended (p < .01). However, these effects did not remain after controlling for symptom covariates (e.g., anxiety, depression, fatigue, sleep quality). Participants with more daily yoga practice (mean of 29 minutes) reported less cognitive impairment postintervention through three months (p = .011), and participants with less daily yoga practice (mean of 18 minutes) or no daily yoga practice did not report these changes. This dose response remained when controlling for symptom covariates. At three months, the intervention group reported more physical activity than controls (p = .032). Cytokine levels did not predict changes in self-reported cognitive impairment.
A 12-week, group Hatha yoga intervention provided by a trained instructor may improve self-reported cognitive impairment in breast cancer survivors. This effect may be mediated by improvements in co-occurring symptoms. Practicing yoga for at least 30 minutes per day may be required for a significant improvement over time in cognitive impairment.
A group Hatha yoga class delivered by a trained facilitator may improve cognitive impairment for breast cancer survivors. However, more research with a longer follow-up period is warranted to determine whether the intervention is effective, what component of the intervention is active, and whether yoga is practical for implementation in practice.
de Raaf, P.J., de Klerk, C., Timman, R., Busschbach, J.J., Oldenmenger, W.H., & van der Rijt, C.C. (2013). Systematic monitoring and treatment of physical symptoms to alleviate fatigue in patients with advanced cancer: A randomized controlled trial. Journal of Clinical Oncology, 31, 716–723.
To investigate whether nurse monitoring and protocol management of physical symptoms alleviates fatigue
Patients were randomized to receive either usual care or nurse management patient-tailored treatment using treatment management protocols. In the experimental group, nurse specialists recorded interventions for multiple physical symptoms. During outpatient meetings with the nurse, symptom severity was monitored. When any symptoms were rated ≥ 4 on an 11-point scale, the nurse referred the patient to the oncologist for further assessment and initiation of treatment according to palliative care guidelines, such as medication adjustment, other referrals, or other interventions. Nurses managed as many symptoms independently as possible. Highly specific interventions for pain, nausea, vomiting, constipation, diarrhea, anorexia, dyspnea, cough, and dry mouth were used. No specific interventions aimed at fatigue were identified. Patients met with the nurse at 1, 2–4, 5–7, and 8–10 weeks. Study assessments were done via mail at baseline and one, two, and three months.
A randomized controlled trial design was used.
Patients reported that the most troublesome symptoms were pain, dyspnea, and anorexia. Patients had a median of two symptoms with NRS scores of at least 4 at baseline. MFI scores for general fatigue declined significantly over time in the intervention group compared to controls, with effect size ranging from 0.26 to 0.35 (p = 0.01). NRS fatigue scores also demonstrated decline compared to usual care controls (p < 0.001). BFI scores were not reported. Overall symptom burden was reported to decrease over time in the intervention group, while there was no change in controls (maximal effect size = 0.64, p = 0.002). Anxiety decreased in the intervention group compared to controls (maximal effect size = 0.32, p < 0.001).
Findings suggest that comprehensive management and monitoring for symptom control by nurse specialists was effective in reducing anxiety and fatigue in patients with cancer.
Findings suggest that continued symptom management and monitoring with a protocol approach can be effective for reducing symptoms overall, and reducing fatigue and anxiety. There were no specific intervention approaches identified that were used for fatigue, so the suggestion is that reducing other symptoms can have a positive impact on fatigue. There were also no specific interventions identified for anxiety, but anxiety also declined over time. These results suggest that ongoing monitoring and attention to patients alone may positively impact these symptoms.