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.
Billingsley, C.C., Jacobson, S.N., Crafton, S.M., Crim, A.K., Li, Q., Hade, E.M., . . . O'Malley, D.M. (2015). Evaluation of the hematologic safety of same day versus standard administration (24- to 72-hour delay) of pegfilgrastim in gynecology oncology patients undergoing cytotoxic chemotherapy. International Journal of Gynecological Cancer, 25, 1331–1336.
To assess the effects of same-day pegfilgrastim administration compared to standard delayed administration among women being treated for gynecologic cancer
Medical records were used for data collection. Women received 6 mg pegfilgrastim on the same day as chemotherapy or within 24–72 hours of chemotherapy administration. Results of absolute neutrophil count (ANC), chemotherapy delay, regimen change related to neutropenia, and incidence of febrile neutropenia (FN) were compared. A 25% difference in risk of these outcomes was established as the noninferiority margin of interest. Sixty-one patients crossed over to the alternate timing of pegfilgrastim during treatment.
Grade 3 or 4 neutropenia was observed more often in the same-day administration group (2.6% versus 1.8%, risk ratio [RR] = 1.62, p = 0.05). No significant differences in treatment delays or dose modifications existed within the established margin.
Same-day pegfilgrastim administration was associated with slightly higher grade 3 or 4 neutropenia.
This study did not provide sufficient evidence to establish safety and effectiveness of same-day pegfilgrastim administration. The findings suggest that altered timing may be safe in terms of looking at treatment delays related to neutropenia. Prospective studies are needed to determine whether same-day administration is appropriate. This approach can be very helpful for patients who need to travel long distances for treatment and may reduce the number of visits required for treatment.
Billhult, A., Bergbom, I., & Stener-Victorin, E. (2007). Massage relieves nausea in women with breast cancer who are undergoing chemotherapy. The Journal of Alternative and Complementary Medicine, 13(1), 53-57.
In this prospective trial, patients were randomly assigned to one of two groups. Patients in the intervention group received five massage sessions (effleurage), lasting about 20 minutes. Patients in the control group received visits by a hospital staff member (attention control).
This was a prospective trial with random assignment.
Interpretation of the findings as written was difficult. Although the authors concluded that massage reduced nausea, nausea was not assessed at expected problem points. For example, severe nausea was measured 30 minutes into the chemotherapy infusion after patients received antiemetic prophylaxis with 5-HT3 and steroid.
Biglia, N., Sgandurra, P., Peano, E., Marenco, D., Moggio, G., Bounous, V., … Sismondi, P. (2009). Non-hormonal treatment of hot flushes in breast cancer survivors: Gabapentin vs. vitamin E. Climacteric, 12, 310–318.
The study assessed the efficacy and the tolerability of gabapentin 900 mg/day compared to vitamin E for the control of vasomotor symptoms in women with breast cancer.
Vitamin E was chosen as a placebo-equivalent on the basis of previous experience showing only minimal effect on hot flushes in breast cancer participants, and no toxicity or side-effects. Participants were randomly allocated to one of two treatment groups: vitamin E 800 IU/day or gabapentin 900 mg/day by oral route (Neurontin 300 mg capsules) for a period of 12 weeks.
The sample was comprised of 115 postmenopausal women with a median age of 50 years.
This was a randomized, non-placebo-controlled, nonblinded study.
Each participant completed a one-week self-report diary on hot flushes at study entry and daily during the 12 weeks of study. In order to assess the duration of treatment efficacy, participants filled out the hot flush diary for three months after treatment discontinuation.
Treatment efficacy was assessed by two measures: frequency (total number of hot flushes) and severity score, calculated by assigning scores of 1, 2, 3 and 4, respectively, to mild, moderate, severe, and very severe hot flushes. This hot flush diary had previously been validated. Each value was obtained by averaging data collected over 1 week. Differences and percentage changes from baseline to weeks 4, 8, and 12 were calculated. Among the women allocated to vitamin E, 16.36% never started therapy, and 34.78% dropped out because of inefficacy. Hot flush frequency and score decreased by 57.05% and 66.87%, respectively (p = 50.05) in the gabapentin group. The effect of vitamin E was fairly small: hot flush frequency and severity score were reduced by 10.02% and 7.28%, respectively (p > 0.05).
Gabapentin 900 mg/day is effective for relieving hot flushes in participants previously treated for breast cancer. Vitamin E has only marginal effect on vasomotor symptoms.
Study limitations were small sample size and high dropout rate.
Biglia, N., Torta, R., Roagna, R., Maggiorotto, F., Cacciari, F., Ponzone, R., … Sismondi, P. (2005). Evaluation of low-dose venlafaxine hydrochloride for the therapy of hot flushes in breast cancer survivors. Maturitas, 52, 78–85.
Outpatient
Open label study
Measures included:
Thirty patients completed the first 4 weeks of treatment with reduction of hot flash frequency of 39% compared to baseline. After eight weeks of treatment, a further significant reduction in hot flashes by 53% and a hot flash score by 59% was observed. Very few side effects were reported, mainly nausea during first the two weeks and mouth dryness. Only 23 women completed the BDI at week 8 with a reduction of 23% reported. No patient was withdrawn for blood pressure increase or major toxicity.
Low-dose venlafaxine hydrochloride can be effective in reducing frequency and severity of hot flashes in patients with breast cancer.
Biglia, N., Kubatzki, F., Sgandurra, P., Ponzone, R., Marenco, D., Peano, E., & Sismondi, P. (2007). Mirtazapine for the treatment of hot flushes in breast cancer survivors: A prospective pilot trial. Breast Journal, 13, 490–495.
The sudy evaluated the efficacy and safety of mirtazapine to reduce hot flashes in women with a previous breast cancer and assessed the influence of the same treatment on sleep quality and other menopausal symptoms.
Treatment was mirtazapine 15 mg/day at bedtime for one week, then 30 mg/day for the next 11 weeks. Primary end point was to compare hot flash score and frequency after 4, 8, and 12 weeks of treatment to the basal values.
The study enrolled 40 consecutive postmenopausal women with a previous history of breast cancer.
It was conducted in an outpatient treatment clinic for menopausal symptoms.
This was a pilot, open-label study.
Sample size was calculated under the assumptions of the detection of a 50% reduction in hot flash frequency, with 80% power at a two-sided alpha level of 0.05. These assumptions, using a dependant samples t-test, required at least 20 evaluable patients. Tools included: Hot flash diary, hot flash score, MRS, PSQI, and the SF 36 Health Survey.
Twenty patients completed the study. After four weeks of treatment, a significant decrease of vasomotor symptoms compared to baseline values was reported. The mean decrease in hot flash frequency was 46.9% and mean reduction in hot flash score was 49%. The benefit increased at week 8 when the mean decreases in frequency and score were 56.5% and 62.16% respectively. The effects remained stable during the last month.
The study was limited by its small sample size. Out of 40 women enrolled in the study 13 (32.5%) withdrew after signing consent and recording basal data and never began therapy; reasons given for withdrawal included were reluctance to take antidepressant drugs or the fear that thedrug may adversely affect cognitive function or cause side effects.
The study should be duplicated in a larger blinded, placebo-controlled trial. There was a possible negative interaction between the antiproliferative effect of tamoxifen on the breast and mirtazapine.