Blackhall, L., Petroni, G., Shu, J., Baum, L., & Farace, E. (2009). A pilot study evaluating the safety and efficacy of modafinal for cancer-related fatigue. Journal of Palliative Medicine, 12, 433–439.
The primary aim was to evaluate the safety and efficacy of modafinil in improving cancer-related fatigue (CRF) in patients with cancer.
The secondary aim was to assess the effect of modafinil on depression, quality of life (QOL), functional status, and cognitive function.
After initial assessment for all outcome measures, patients were treated with self-administered modafinil at an initial dose of 100 mg per day during weeks one to two. During weeks three to four, the dose was increased to 200 mg per day. All study parameters were reassessed at week two and at week four (completion of the trial).
This was an open-label pilot study.
BFI was improved at two weeks for 46% of participants, and at four weeks, 75% had a significantly improved score (p = 0.025). FACT-BR showed an improvement in all subsets of well-being except social/family at two and four weeks (p < 0.05). HADS score declined significantly at two and four weeks (p < 0.001). Cognitive function was not significantly changed, except TMT-B showed a trend for an overall improvement. Functional status (Barthel Index) did not change, but overall performance status (ECOG) improved, with 40% of patients improving at least one level. Most side effects were mild. Side effects seen were dizziness, nausea, diarrhea, and heartburn.
Modafinil use was associated with improvement in fatigue, depression, and QOL measures and was well tolerated.
Björneklett, H. G., Lindemalm, C., Ojutkangas, M. L., Berglund, A., Letocha, H., Strang, P., & Bergkvist, L. (2012). A randomized controlled trial of a support group intervention on the quality of life and fatigue in women after primary treatment for early breast cancer. Supportive Care in Cancer, 20, 3325–3334.
To evaluate the effects of a psychosocial support intervention on health-related quality of life (QOL) and fatigue.
Participants were randomized to an intervention or usual care control group. The intervention consisted of education sessions mixed with exercise, relaxation training, massage, qigong, visualization, and social activities, such as concerts and museum and restaurant visits. As reported in a previous pilot study, participants were residents at a spa-type facility during the intervention. The intervention was provided by an interdisciplinary group comprising physicians, psychologists, an art therapist, a massage therapist, a dietician, social workers, and a trained qigong provider for seven days. Follow-up was performed at two, six, and 12 months. Participants in the usual care control were only provided follow-up data collection.
The study was a randomized, controlled trial.
Fatigue scores were similar in both groups and declined over time up to 12 months in both groups. There were no differences in fatigue levels over time between the groups. There were no significant effects of the intervention on QOL measures.
The multimodal intervention demonstrated no significant effect on QOL or fatigue.
The specific approach providing a multifaceted, psychoeducational type of intervention was not shown to affect fatigue or QOL in women with breast cancer. The most effective content, duration, and frequency of psychosocial and multimodal support interventions were not clear.
Björneklett, H.G., Rosenblad, A., Lindemalm, C., Ojutkangas, M.L., Letocha, H., Strang, P., & Bergkvist, L. (2013). Long-term follow-up of a randomized study of support group intervention in women with primary breast cancer. Journal of Psychosomatic Research, 74(4), 346–353.
Long-term follow-up to evaluate quality of life after support group intervention in a randomized group of women with primary breast cancer presenting for postoperative radiotherapy.
The current study is a long-term follow-up 5–9 years after randomization into groups. The intervention and control groups were stratified by chemotherapy or nonchemotherapy treatment. The intervention was a one-week support group with four days of follow-up two months postintervention during residential care at the Foundation of Lustgården Mälardalen. The intervention involved lectures and group discussions about the etiology of cancer, risk factors, treatment, physical and psychological effects, and coping strategies. Patients engaged in physical exercise, relaxation, Qigong, and nonverbal communication exercises, as well as art and dance therapy. All participants completed questionnaires at baseline and follow-up questionnaires at 2, 6, and 12 months postintervention. The control group participated only in routine follow-up at the Department of Oncology or the Department of Surgery.
Fatigue symptoms improved over time, which was a significant finding in the intervention and control groups. Being upset about hair loss improved over time in the intervention group. High anxiety scores improved over time and were not significantly different between the two groups in long-term follow-up. Depression scores were high at follow-up for seven women in each group, and no significant difference was found at baseline and postintervention, adjusting for covariates. Neither group showed improvement between the 12-month follow-up and long-term follow-up.
Effects of support group intervention may provide a sense of security that can fade over time, reversing improvements in anxiety and depression. Treatment-related fatigue may improve over time. Significant improvement was found in cognitive function, body image, and future perspective, but no significant effect was found on levels of anxiety and depression.
Women who have received chemotherapy have greater symptom severity and may benefit more on global health and cognitive function fatigue, when compared to women who have not received chemotherapy. Additional research is needed to evaluate the influence of exercise and psychosocial support interventions, according to patient needs for content, duration, and an assessment of spiritual well-being using the Functional Assessment of Chronic Illness Therapy (FACIT).
Björneklett, H.G., Lindemalm, C., Rosenblad, A., Ojutkangas, M.L., Letocha, H., Strang, P., & Bergkvist, L. (2012). A randomised controlled trial of support group intervention after breast cancer treatment: Results on anxiety and depression. Acta Oncologica, 51, 198–207.
To evaluate the effect of a support program on anxiety and depression in patients with breast cancer
The intervention was a weeklong multidisciplinary residential program. The intervention took place within four months after the end of tumor treatment and ran for seven days, followed by four days of follow-up two months after the initial visit. The team consisted of oncologists, social workers, art therapists, massage therapists, a dietitian, and a mindfulness practitioner.
A randomized controlled trial design was used.
Hospital Anxiety and Depression Scale (HADS)–Swedish version
After 12 months, 10% in the intervention group versus 19% in the control group had a high anxiety score (p = 0.055).
Support group intervention including education about the disease and psychological reactions, mixed with art and dance therapy, qigong, and relaxation, was shown to positively influence anxiety levels among patients with breast cancer over time, whereas depression levels were unaffected by the intervention.
Because of costs and time constraints, the ability of this program to be replicated is suspect. The particular components of the program that provided the most effectiveness were not analyzed and therefore cannot be reproduced or further studied.
Bjordal, J.M., Bensadoun, R.J., Tuner, J., Frigo, L., Gjerde, K., & Lopes-Martins, R.A. (2011). A systematic review with meta-analysis of the effect of low-level laser therapy (LLLT) in cancer therapy-induced oral mucositis. Supportive Care in Cancer, 19, 1069–1077.
Review the effects of low level laser therapy (LLLT) in prevention and treatment of oral mucositis induced by cancer therapy. Meta-analysis was done, and all results are provided.
Databases searched were Medline, EMBASE, CINAHL, PedRo, and Cochrane Controlled Trial Register. Hand searching in physiotherapy and medical journals from several countries also were used.
Search keywords were low level laser therapy, low intensity laser therapy, low energy laser therapy, phototherapy, oral mucositis, cancer, chemotherapy, radiation therapy, and specific laser types.
Studies were included if they
A total of 149 papers were initially retrieved. Literature was evaluated using the Jadad checklist and inclusion of study funding sources.
A final sample of 11 trials published from 1997–2009 included 415 patients. Samples ranged from 21–70 subjects and included those receiving chemotherapy, radiation therapy, combined therapy, and transplant cases. One study was done in children.
Moderate to strong evidence was found for effectiveness of LLLT in the prevention of OM, reduced duration and severity of OM, and reduced pain with doses of 1–6 joules per point. Trials aimed at prevention started LLLT seven days before cancer treatment regimens, and effective dosing seen ranged from 1–6 joules. This meta-analysis supported the effectiveness of LLLT in the dosage ranges reported here for the prevention and management of oral mucositis.
The quality of studies was determined to be high; however, substantial variation existed in the actual treatment procedures, number of treatments, timing of treatments, and heterogeneity in the overall findings.
Biswal, B.M., Sulaiman, S.A., Ismail, H.C., Zakaria, H., & Musa, K.I. (2013). Effect of Withania somnifera (ashwagandha) on the development of chemotherapy-induced fatigue and quality of life in breast cancer patients. Integrative Cancer Therapies, 12, 312–322.
To examine the effects of Withania somnifera (WS) on fatigue and quality of life among patients with breast cancer receiving chemotherapy
WS was supplied as a powder in 500 mg capsules. Patients was asked to take four capsules three times daily for total daily dose of 6 g. Patients were followed for six cycles of chemotherapy. Study measures were conducted at baseline and periodically through treatment. Some measures were conducted on the first day of every cycle, and others were conducted on the first day of cycle 1, 3, and 6. Consecutive patients were alternately assigned to treatment or usual care groups.
Several QOL measures were significantly better in the treatment group compared to controls: physical functioning (p < .001), role functioning (p < .001), insomnia (p < .001), loss of appetite (p = .011), emotional functioning (p < .001), and social functioning (p < .001). Fatigue scores were significantly better as shown by repeated measures ANOVA in the intervention group (p ≤ .003). Ninety-eight percent of intervention patients found the intervention acceptable.
Findings suggest that the herbal treatment of WS is beneficial for the management of fatigue in patients with breast cancer undergoing chemotherapy.
The herbal treatment of WS, which has been used in Ayurveda medicine, may be beneficial to reduce fatigue in patients with cancer. This particular study has several important limitations; however, results are promising. Additional well-designed research with this herbal remedy is warranted.
Bischoff, K., Weinberg, V., & Rabow, M.W. (2013). Palliative and oncologic co-management: Symptom management for outpatients with cancer. Supportive Care in Cancer, 21, 3031–3037.
To assess the association between palliative care management, symptoms, and quality of life
Clinical records of patients referred for outpatient palliative care who had follow-up visits within 120 days of initial referral were included. Retrospective analysis of clinical data was done.
At the time of initial visit, average symptom scores were 2.9–5.8 (10-point scale). At the first follow-up visit, there was an average 0.67-point improvement in pain (p < .001), a 0.67-point improvement in fatigue (p < .001), a 0.94-point improvement in depression (p < .001), and a 0.89-point improvement in anxiety (p < .001). At least 50% of patients reported a greater than one-point improvement in symptoms by the first follow-up visit, and 16%–25% reported a one-point or greater worsening of symptoms. Among 142 patients who had a second follow-up visit, there was continued significant improvement from baseline symptom scores. Patients on active treatment had less improvement in fatigue than others (p = .02).
Most patients who continued follow-up by palliative care demonstrated improvement in pain, fatigue, anxiety, and depression.
Palliative care, with attention to symptom management, has been shown to be effective in reducing symptom severity for the majority of patients. It is not clear, however, if formal palliative care services result in better outcomes than attention to symptom management in general. It would be expected that, whether provided by oncology or palliative care providers, focused attention on symptom management would result in improvement of symptoms. The optimum frequency of follow-up and timing for optimal symptom control has not been determined.
Birocco, N., Guillame, C., Storto, S., Ritorto, G., Catino, C., Gir, N., . . . Ciuffreda, L. (2012). The effects of Reiki therapy on pain and anxiety in patients attending a day oncology and infusion services unit. American Journal of Hospice and Palliative Care, 29, 290–294.
To examine the effects of Reiki on pain, anxiety, and global wellness among patients with cancer who are receiving chemotherapy
Reiki sessions were offered to patients in a day oncology and infusion services unit that provided chemotherapy. Patients sat in a chair or lay on a bed during Reiki sessions. Each session lasted approximately 30 minutes. Each patient received a maximum of four Reiki sessions. Prior to each session, Reiki practitioners assessed levels of anxiety and pain according to a numeric scale. After each session, levels of pain and anxiety were recorded on a visual analog scale. The study was done over three years.
Patients were receiving active antitumor treatment.
A prospective pre/post-test design was used.
Only 48% of patients had more than one Reiki session, and only 22 patients (17%) completed four sessions and were included in statistical analysis. From session 1 to session 4, mean anxiety scores post-Reiki session declined, but scores immediately after each time point were higher than those reported immediately prior to the session.
Findings of this study do not support the effectiveness of Reiki. The study included numerous limitations in study design and methods.
This study does not support the effectiveness of Reiki. The study and methods were not well designed or reported.
Birnie, K., Garland, S.N., & Carlson, L.E. (2010). Psychological benefits for cancer patients and their partners participating in mindfulness-based stress reduction (MBSR). Psycho-Oncology, 19, 1004–1009.
To conduct a preliminary exploration of mindfulness-based stress reduction (MBSR) participation of couples affected by cancer, particularly as participation affects symptoms of stress, mood disturbance, and mindfulness for patients with cancer and their partners
A convenience sample of 41 couples already enrolled in an MBSR program at a cancer outpatient center agreed to participate by completing the three study measures before the program started and two weeks following program completion. Weekly 90-minute classes held over an eight-week period, plus one weekend retreat lasting three to six hours, comprised the intervention. Of the 41 couples, only 21 completed post-test measures and at least six of eight MBSR classes.
A pretest/post-test design was used.
Of the couples, 21 provided POMS data, 19 provided C-SOSI data, and 16 provided MAAS data for baseline and postintervention measures. Before MBSR intervention, patients reported significantly higher scores on the POMS fatigue subscale (p = 0.05), while partners reported significantly higher scores on the C-SOSI sympathetic arousal subscale (p < 0.05) than did patients according to t-test analysis. Patients with only baseline data reported significantly higher levels of total mood disturbance before MBSR classes than those who provided complete data (p < 0.05). After program completion, both patients and partners experienced significant reduction in mood disturbance (p < 0.05) and the C-SOSI subscales of muscle tension (p < 0.01), fatigue (p < 0.05), neurologic/GI (p < 0.05), and upper respiratory symptoms (p < 0.01). Both groups significantly increased their mindfulness (p < 0.05) as a result of the intervention. After the MBSR intervention, couples’ scores on the POMS and C-SOSI were more highly correlated with one another. Partners’ mood disturbance scores were positively correlated (p < 0.05) with patients’ symptoms of stress and negatively correlated with patients’ levels of mindfulness (p < 0.05).
As one of the first studies using a sample of patients with cancer and partners, the MBSR program benefited both patients and their partners by reducing mood disturbance and physical symptoms of stress, psychologically aligning patients and partners during the cancer journey, and increasing levels of mindfulness. Moderate effect sizes were found for both patients and partners on these variables.
MBSR programs for patients with cancer and their partners may buffer physical and psychological challenges during their cancer journey. Nurses, as members of the healthcare team, may suggest these increasingly evidence-based programs as a complementary intervention for patients and partners who seek additional nonmedical ways to cope with the cancer illness. Validation of MBSR will enhance couples’ willingness to seek out MBSR that may respond to psychosocial gaps in care of patients with cancer and their partners who struggle with predominant high-technology approaches to oncology care. Further examination is also needed to identify cost-effective ways of meeting healthcare system goals for person-centered care in diverse populations of families facing cancer.
Billio, A., Morello, E., & Clarke, M.J. (2010). Serotonin receptor antagonists for highly emetogenic chemotherapy in adults. Cochrane Database of Systematic Reviews (Online), CD006272.
To compare the effectiveness of different 5-HT3 receptor antagonists (RAs) in the control of acute- and delayed-onset emesis associated with highly emetogenic chemotherapy
Databases searched were Cochrane Register of Clinical Trials (CENTRAL), PubMed, Embase, and Latin American and Caribbean Health Sciences Literature (LILACS).
Search keywords were MeSH for granisetron; ondansetron, tropisetron, dolasetron, ramosetron, palonosetron, azasetron, in all possible comparison sets; chemotherapy, antineoplastic agents, and cisplatin. Internet databases of gray literature were searched, and hand searching was performed of potentially relevant journals and conference proceedings.
Studies were included in the review if they
Studies were excluded if they
Of the 25 studies found that met the eligibility criteria, 16 RCTs were included. These studied granisetron, ondansetron, tropisetron, ramosetron, palonosetron, and dolasetron. Four studies were excluded because of inadequate outcome assessment, two studies because of the unavailability of the protocol, one study because of very poor methodological quality, and one study because it included patients receiving only moderately emetogenic therapy.
The final sample of 16 studies reported on 7,808 patients across all studies.
Acute nausea
Total control of acute nausea and vomiting
Delayed nausea
Total control of delayed nausea and vomiting
Meta-analysis of granisetron and ondansetron
Further RCTs comparing palonosetron and dexamethasone for delayed nausea are warranted.