Furmaniak, A.C., Menig, M., & Markes, M.H. (2016). Exercise for women receiving adjuvant therapy for breast cancer. Cochrane Database of Systematic Reviews, 9, CD005001.
STUDY PURPOSE: To assess the effects of aerobic and resistance exercise on treatment-related side effects during adjuvant treatment for breast cancer
TYPE OF STUDY: Meta-analysis and systematic review
PHASE OF CARE: Active antitumor treatment
The findings show a moderate effect of exercise on fatigue among women receiving adjuvant treatment for breast cancer. No significant effects were seen for depression or anxiety. A statistically significant effect for cognitive function was found; however, the evidence was deemed to be of low quality.
Exercise probably reduces fatigue and improves physical fitness among women during treatment for breast cancer. Adherence to exercise can be a challenge, and implementation of exercise recommendations or programs will need to address factors to foster exercise participation to be successful.
Fukuoka, S., Shitara, K., Noguchi, M., Kawazoe, A., Kuboki, Y., Bando, H., . . . Yoshino, T. (2016). Prophylactic use of oral dexamethasone to alleviate fatigue during regorafenib treatment for patients with metastatic colorectal cancer. Clinical Colorectal Cancer. Advance online publication.
To investigate the effect of dexamethasone (DEX) on fatigue and other toxicities in patients treated with regorafenib
Data were obtained from medical records for analysis. DEX was given to some patients prophylactically at the physician’s discretion at 2 mg/day throughout regorafenib treatment. Data from those given DEX versus those not given DEX were analyzed. Patients received 120–160 mg regorafenib on weeks 1–3 of each four-week cycle.
PHASE OF CARE: Active antitumor treatment
Retrospective cohort
Common Terminology Criteria for Adverse Events (CTCAE)
The most frequent adverse event leading to dose modification in both groups was hand-foot syndrome (55.6%). No patients in the DEX group had dose modification because of fatigue compared to 8% in the non-DEX group. Median time to dose modification was longer in the DEX group (p = 0.009). The incidence of fatigue was lower in the DEX group (25.8% versus 50%, p = 0.022). The incidence of at least grade 3 hand-foot syndrome was lower in the DEX group (3% versus 25.7%, p = 0.002). The incidence of oral candidiasis was greater in the DEX group (16.2% versus 0%, p < 0.001).
Systemic corticosteroids were associated with a lower incidence of more severe hand-foot syndrome but also associated with a higher incidence of oral candidiasis in this group of patients.
Prophylactic oral DEX was associated with reduced fatigue and incidence of hand-foot syndrome in patients receiving regorafenib. Systemic DEX may reduce some treatment side effects but was also associated with the development of oral candidiasis. Effectiveness of prophylactic DEX and associated adverse effects warrant further investigation. Nurses need to be aware of the potential infectious complications of patients receiving systemic corticosteroids, and the effects of long-term use needs to be investigated.
Fukui, S., Ogawa, K., Ohtsuka, M., & Fukui, N. (2008). A randomized study assessing the efficacy of communication skill training on patients' psychologic distress and coping: Nurses' communication with patients just after being diagnosed with cancer. Cancer, 113, 1462–1470.
To investigate whether a communication skill training program for nurses would reduce psychological distress and improve coping among patients newly diagnosed with cancer
The communication skill training (CST) program involved two workshops, one at the start of the study and the other after three months. Workshops lasted six hours and were structured in a six-step approach (SPIKES) involving (1) setting up the interview, (2) assessing the patient’s perception of his or her illness, (3) obtaining a patient invitation to disclose information, (4) giving information and knowledge to the patient, (5) addressing the patient's emotion with empathic responses, and (6) strategy and summary. The program involved a large group meeting on theoretic content followed by small facilitated group work in which nurses worked through various scenarios using the SPIKES steps. Study patients were randomly assigned to be interviewed three times by nurses who attended the CST program (experimental group) or interviewed the same three times by nurses in the control group. Interviews were scheduled on the day of diagnosis, and one week and one month after diagnosis. Study measurements were done at one week after diagnosis (T1), one month after diagnosis (T2), and three months after (T3). Nurses were randomly assigned to either CST or usual care provision.
Patients were undergoing the diagnostic phase of care.
A randomized controlled trial design was used.
There was a significant different in HADS depression and total scores over time associated with group (p = 0.03). These scores declined over time in both groups; however, the decline was greater for the experimental group. There was no group interaction or for anxiety. There were no significant changes in any other HADS data. MAC score changes over time showed mixed results. The only consistent directional change in the experimental group, as compared to the control group, was in the area of fatalism, with decline over time in the experimental group and increase over time in the control group (p = 0.04).
CST appears to have a positive effect on psychological distress and some areas of coping for patients newly diagnosed with cancer.
Study findings support the idea that providing information, support, and empathic responses to patients can positively influence patient coping and emotional distress, and suggest that nurse training in communication skills of this nature can be useful. Further research in this area needs to demonstrate actual differences in communications between nurses and patients as a result of such training. It would be useful to see if such training can be beneficial in various groups of nurses based on differences in nursing education level and experience.
Fujii, H., Iihara, H., Ishihara, M., Takahashi, T., Yoshida, K., & Itoh, Y. (2013). Improvement of adherence to guidelines for antiemetic medication enhances emetic control in patients with colorectal cancer receiving chemotherapy of moderate emetic risk. Anticancer Research, 33, 5549–5556.
To determine whether an intervention could improve antiemetic guideline adherence and the control of chemotherapy-induced nausea and vomiting (CINV)
Evidence-based antiemetic medication information was provided as notification to physicians in a view format. The description of the intervention was not clear, and it was presumed that the notification was provided in some manner through the electronic medical record system. CINV control after the intervention was compared to CINV control in a cohort of patients treated prior to the intervention.
Cohort comparison
The dosage of oxaliplatin or irinotecan was higher in the intervention group (p < 0.01). In the observational group, adherence to guidelines was 100% in the acute phase and 6.6% in the delayed phase. Nonadherence was caused by the lack of a prescription of dexamethasone on days 2 and 3. After the intervention, adherence to the administration of dexamethasone was 89%. In the intervention group, the complete protection rate was 20% higher after the intervention (p < 0.05), but adherence during the acute phase dropped and was significantly lower in the intervention group (p < 0.01). The incidence of leukopenia was higher in the intervention group (42.2% versus 23%, p = 0.024). There were no other differences in toxicity.
The intervention used in this study had mixed results in terms of adherence to CINV antiemetic guidelines and control of CINV in acute and delayed phases.
In this study, an organizational intervention had mixed results in improving adherence to antiemetic guidelines and patient CINV outcomes. The findings were limited by the lack of detail regarding the specific intervention used, but it appears to have been a notification in the medical record with no other action. Organizational initiatives to improve practice are not all created equally, and such studies need to provide sufficient detail about the actual intervention to determine if approaches that are effective in creating practice changes and improvements in patient outcomes.
Fuccio, L., Guido, A., Eusebi, L. H., Laterza, L., Grilli, D., Cennamo, V., … Bazzoli, F. (2009). Effects of probiotics for the prevention and treatment of radiation-induced diarrhea. Journal of Clinical Gastroenterology, 43(6), 506–513.
To evaluate the effectiveness of probiotic supplementation for the prevention and treatment of radiation-induced diarrhea
Databases searched were PubMed, EMBASE, Cochrane Library, Google Scholar, and online clinical trials registers (Cochrane Central Register of Conrolled Trials, metaRegister of Controlled Trials, National Institutes of Health) until January 2009. Other relevant trials were identified from the reference list of selected articles. Abstracts presented up to 2008 at the United European Gastroenterology Week meetings, American Society for Therapeutic Radiology and Oncology Annual Meetings, and American Gastroenterological Association Digestive Disease Week were searched manually.
Search keywords were diarrhea, probiotics, radiotherapy, radiation therapy, Lactobacilli, Bifidobacteria, Enterococci, VSL no. 3, pelvic tumors, and abdominal tumors.
Studies were included in the review if they were randomized, controlled trials with at least two parallel groups that evaluated the effectiveness of probiotic supplementation to prevent or treat radiation-induced diarrhea.
Studies were excluded if they were review articles, involved nonradiation-induced diarrhea, or covered radiation-induced gastrointestinal (GI) symptoms other than diarrhea.
The abstracts of 58 articles were reviewed. Fifty evaluated the effects of probiotic supplementation for conditions other than radiation therapy and were eliminated. Of the remaining eight, three were duplicate reports and one studied radiation-induced chronic bowel discomfort rather than diarrhea.
The remaining four studies were selected for this review. Three were randomized controlled trials evaluating probiotic supplementation for the prevention of radiation-induced diarrhea, and one trial evaluated probiotic supplementation for the treatment of radiation-induced diarrhea.
Three studies evaluated the use of probiotic supplementation to prevent radiation-induced diarrhea. A total of 632 individuals initially were randomized to the studies; the final sample sizes were 21, 85, and 482. The study using probiotic supplementation to treat radiation-induced diarrhea had a sample size of 205 patients, with 102 receiving the intervention and 103 receiving a placebo.
The few available studies on the use of probiotics to prevent or treat radiation-induced diarrhea do not allow for firm conclusions to be drawn regarding the benefits of this intervention.
The studies included in the systematic review and meta-analysis used different single strains and different doses of probiotics.
More studies using preparations containing several strains of probiotics and studies looking at comparisons between different probiotics are needed.
Fuccio, L., Guido, A., Laterza, L., Eusebi, L.H., Busutti, L., Bunkheila, F., . . . Bazzoli, F. (2011). Randomised clinical trial: Preventive treatment with topical rectal beclomethasone dipropionate reduces post-radiation risk of bleeding in patients irradiated for prostate cancer. Alimentary Pharmacology & Therapeutics, 34(6), 628–637.
To determine the effectiveness of topical rectal beclomethasone dipropionate (BDP) in the prevention of rectal proctopathy, which can lead to rectal bleeding, in patients undergoing radiation therapy for prostate cancer
The treatment arm consisted of a 3 mg BDP enema each evening before radiotherapy treatments and two 3 mg BDP suppositories (one in the morning and one in the evening daily) over four weeks. The placebo arm consisted of an identical looking enema and suppository given at the same intervals without medication. Time points for clinical evaluation were before radiotherapy, one month after completion of the treatment, and every three months thereafter. Time points for endoscopic evaluation were before treatment, at three months, and at 12 months postradiotherapy. The patients self-administered the treatment, and they were asked to hold the medication in for as long as they could and return the unused materials at the end of the study to assess compliance.
Double-blind, placebo-controlled, randomized trial
With respect to bleeding rate, the BDP group showed a statistically significant lower amount of blood in stools (OR = 0.38; 95% CI 0.17–0.86). The patients in the BDP arm showed a later onset of blood in stools overall (p = 0.032). The quality of life IBDQ score was significantly lower in patients randomized to BDP who reported rectal bleeding (p < 0.001). Severe hemorrhagic proctopathy, defined as anemia with a drop in hemoglobin of at least 1.5 g/dL, was found in 10 patients (four in the BDP group and six in the placebo group).
The BDP therapy arm of this study seemed to fair better with respect to bleeding risk postradiation and the prevention of some of the mucosal changes that lead to significant complications. It does not seem to affect other quality of life issues like continence and diarrhea. Changing the formulation of the BDP and/or its frequency of usage may improve outcomes for patients. Since the treatment did not cause harm to patients, it seems to be a good recommendation for patients to try.
It would be best for nurses to train patients on the usage of BDP during and following radiation therapy. A nursing study to evaluate methods of application and quality of life for patients would be the next step to further improve this research.
Fu, M.R., Axelrod, D., Guth, A.A., Cartwright, F., Qiu, Z., Goldberg, J.D., . . . Haber, J. (2014). Proactive approach to lymphedema risk reduction: A prospective study. Annals of Surgical Oncology, 21, 3481–3489.
To evaluate the safety, feasibility, and acceptability of the Optimal-Lymph-Flow™ program for patients with breast cancer and to evaluate its benefit when introduced presurgically
The Optimal-Lymph-Flow™ (OLF) program is a patient self-care program designed to reduce the development of lymphedema through specific exercises and behaviors to improve lymph flow and reduce or maintain body mass index (BMI). Participants were recruited preoperatively and followed prospectively for 12 months after surgery. Trained nurses provided each participant with the study intervention through a 30-minute face-to-face meeting. Participants were trained in various exercise techniques and then did a return demonstration (shoulder, breathing, and pumping exercises). They also were instructed in a nutrition-balanced and portion-appropriate diet to maintain preoperative BMI. Participants’ limb volume was measured with a Perometer, and BMI was measured with bioimpedance presurgery, two to four weeks after surgery, and at 6–12 months. Any patient with a limb volume measurement ≥ 10% was referred for complete decongestive therapy. If a 5% increase in limb volume occurred, patients were instructed to increase OLF activities, and limb volume was rechecked a few weeks later.
Prospective, longitudinal, quasi-experimental design with repeated measures
One-hundred and thirty-four participants completed the study. At each follow-up visit, no participants reported injury or discomfort associated with the OLF program, making it safe. It took about 30 minutes for the trained nurses to deliver the program, making it feasible. Greater than 90% of the patients reported that the OLF program helped them reduce their fear and anxiety of developing lymphedema, making it acceptable.
The majority (97%) of patients maintained or improved their preoperative limb volumes and BMIs at the study endpoint of 12 months following surgery.
All four women who experienced a 10% lymph volume increase two to four weeks post-surgery and at six months decreased their lymph volume to less 5% at the 12-month visit. BMI did not change significantly. No control group was used, so the benefits of this treatment could not be determined.
This educational and behavioral program may be effective to enhance lymphedema risk reduction. The study provided initial evidence for an emerging change in lymphedema care from treatment focus to proactive risk reduction.
Studies with more rigorous research designs (i.e., randomized, controlled trials) are needed to replicate the findings from this study, evaluate the effectiveness of the OLF program, and determine the dosage and contribution of individual components of the program.
Frisk, J., Källström, A. C., Wall, N., Fredrikson, M., & Hammar, M. (2012). Acupuncture improves health-related quality-of-life (HRQoL) and sleep in women with breast cancer and hot flushes. Supportive Care in Cancer, 20, 715–724.
To evaluate the effectiveness of electroacupuncture (EA) and hormone therapy (HT) on health-related quality of life (HRQoL) and sleep in breast cancer survivors with vasomotor symptoms.
Women who had completed treatment for breast cancer were randomized to receive EA for 12 weeks or HT for 24 months. They completed the Psychological and General Wellbeing Index (PGWI) and Women’s Health Questionnaire (WHQ) pretreatment for vasomotor symptoms; during treatment; and at 6, 9, 12, 18, and 24 months after the start of treatment.
Women were excluded if they were receiving ongoing breast cancer treatment other than tamoxifen; had other malignancies; or had a history of thromboembolic, cereverbrovascular, or liver disease; porphyria; or active cardiovascular disease.
The study was a multicenter, randomized, prospective trial.
Nineteen women completed 12 weeks of EA. Eleven women were excluded due to changes in treatment. About 40% of the patients had no other treatment. The HT group had 11 women complete the 24 months of treatment. In both groups, reduction of hot flushes was noted. The EA group had a decrease in the median number of flushes/24 hours of 55% (p < 0.001) after 12 weeks. The decrease was 29% (p = 0.026) after 24 months. In the HT group, the median number of hot flushes/24 hours decreased by 100% (p = 0.001) after 12 weeks of treatment with no further changes. Sleep parameters improved significantly in both groups from baseline, with a WHQ sleep score in the EA group at baseline of 0.50 and at 24 months 0.33; in the HT group, the baseline score of 0.33 to declined 0.00 at 24 months.
The study showed improvement in sleep scores of both groups up to 21 months. The numbers of hours slept per night did not increase, but the numbers of flushes and distress caused by them decreased, resulting in fewer times woken, with overall improvement in HRQoL. Both groups also showed a significant decrease in the number of HF experienced, which was maintained up to 21 months after treatment was stopped.
EA, compared to HT for management of hot flashes in breast cancer survivors, shows some potential benefit in reducing numbers of hot flashes/24 hours, improving overall WHQ scores.
HT is not recommended as a safe treatment for vasomotor symptoms for breast cancer survivors. Thus, the value of using that group to compare with a group that received EA is of concern. EA needs further investigation in larger sample sizes. Further research is needed for efficacy of EA in hot flash management for breast cancer survivors and in women treated with aromatase inhibitors experiencing hot flash distress, as this study did not address that phenomenon.
Frisk, J. (2010). Managing hot flushes in men after prostate cancer--a systematic review. Maturitas, 65(1), 15-22.
To describe hot flushes in men with prostate cancer and their treatment methods.
TYPE OF STUDY Systematic review
DATABASES MEDLINE, ISI Web of Knowledge, Cinahl & PsycINFO
KEYWORDS Prostate cancer, androgen deprivation therapy, vasomotor symptoms, hot flashes treatment
INCLUSION CRITERIA All studies were randomized controlled studies (RCT) that addressed hot flashes (HF) in men with any stage of prostate cancer, treated with androgen deprivation therapy either medically or surgically. The studies addressed treatment for hot flashes where the main outcomes were frequency of hot flushes, distress from hot flushes, or hot flash score.
EXCLUSION CRITERIA Studies were limited to human studies and publications appearing between 1966 - 2009. Excluded were reviews & meta-analysis.
TOTAL REFERENCES RETRIEVED: 252
METHOD OF STUDY EVALUATION The Jadad score was used to assess the quality of the randomized controlled trial (RCT), on a five-point scale, and the QUORUM guidelines for systematic review were considered.
This summary did not include the measures that were used by the participants in reporting their hot flashes: i.e, diaries, skin temperature measurements, QOL surveys.
FINAL NUMBER STUDIED INCLUDED; N = 5 TOTAL SAMPLE SIZE: N = : 328 men were analyzed. SAMPLE RANGE ACROSS STUDIES : Sample sizes ranged from 12 - 177.
KEY SAMPLE CHARACTERISTICS: Samples included men with prostate cancer who had undergone surgical or medical castration and were currently experiencing hot flushes.
PHASE OF CARE Active Treatment
APPLICATIONS Late Effects and Survivorship; Elderly Care
In the five studies analyzed, the treatments that were studied included cyproterone acetate (CA), megestrol acetate (MA), gabapentin, transdermal clonidine, and diethylstilbestrol (DES). Unfortunately, none of the studies analyzed the same treatment. Because the studies looked at different interventions to relieve hot flushes (HF) in castrated men with prostate cancer, it was not possible to combine the studies to strengthen the outcomes. The studies' outcomes demonstrated varying degrees of success in relieving the hot flushes: Cyproterone acetate 100 mg, once per day, yielded 75% fewer HF than placebo (p<0.001), and 100% of men on CA had a 50% or greater reduction of mean number of HF, compared to placebo group. Megestrol acetate 20 mg, twice per day, yielded an 80% reduction of the median number of HF compared to a 19% reduction in the placebo group (p<0.001), an 87% reduction of median HF score vs. a 16% reduction for placebo (p<0.001), and a 50% or greater reduction of median number of HF (p<0.001) reported by 79% of MA group and 12% of placebo group. Gabapentin (4 schedules) achieved a 45.5% reduction of the median number of HF with 900mg gabapentin per day vs. 21.5% with placebo (p=0.02). Transdermal clonidine demonstrated no difference between the treated group and placebo. Diethylstilbestrol (1 mg) yielded a 100% reduction in the median number of HF vs.13% with placebo. 100% of DES and 14% of placebo reported a 50% or greater reduction of the median number of HF.
The systematic review of studies on treatment approaches to managing hot flushes in men after castration for prostate cancer showed very few such studies. Only five RCT studies were identified, and none of them analyzed the same treatment approach. Several of the studies that were presented demonstrated successful treatment approaches, including DES as the most effective, followed closely by MA and CA. However, these medications are linked to side effects that are not well tolerated by all patients.
Only five RCT studies were identified, and none of them analyzed the same treatment approach.
Large randomized placebo controlled studies are needed to clarify the data and provide clearer direction to managing HF in men who have been castrated as a treatment for prostate cancer. The summary, although providing insight for possible medical management, addressed only briefly the drop-out rates due to side effects. Further investigations of the drop-out subgroup could explore correlations among the medications to reveal unacceptable side effects in managing the participants’ hot flash symptoms. Further investigations comparing medications used and providing more specific information about measurements of QOL and hot flash reporting by participants are warranted.
Frisk, J., Carlhall, S., Kallstrom, A.C., Lindh-Astrand, L., Malmstrom, A., & Hammar, M. (2008). Long-term follow-up of acupuncture and hormone therapy on hot flushes in women with breast cancer: A prospective, randomized, controlled multicenter trial. Climacteric, 11, 166–174.
To evaluate the effects of electro-acupuncture (EA) and hormone therapy (HT) on vasomotor symptoms in women with a history of breast cancer
Twenty-seven women were randomized to EA for 12 weeks, 18 received HT for 24 months. The total population was 45.
This was an international, multicenter study, HABITS19, involving patients from three centers in Sweden between April 1998 and December 2002.
Randomized, controlled study
The patients were monitored with daily entries made in a log book, recording the numbers of hot flashes during day and night and how disturbing they were (range 0 for no distress to 10 for worst possible distress). The log books were completed daily for 1–3 weeks before treatment, continuously during the first 12 weeks of treatment, and thereafter for 1 week per month; altogether for 24 months. The measuring points were baseline, the 12th week of treatment, and at 1 week and 6, 9, 12, 18, and 24 months after start of treatment.
In 19 women who completed 12 weeks of EA, the median number of hot flashes per 24 hours decreased from 9.6 at baseline to 4.3 at 12 weeks of treatment. At 12 months after start of treatment, 14 women with only the initial 12 weeks of EA had a median number of flashes per 24 hours of 4.9, and at 24 months 7. Women with no other treatment than EA had 2.1 hot flashes per 24 hours.
Limitations included small sample size and relatively large attrition rate.