Complementary medicine for fatigue and cortisol variability in breast cancer survivors: a randomized controlled trial

BACKGROUND:

Fatigue is a chief complaint in cancer patients, and warrants effective treatment. Biofield therapies are complementary medicine approaches used by cancer populations. There is little information about their efficacy.

METHODS:

This blinded, randomized controlled trial examined the effects of 4 weeks (eight 1‐hour sessions) of biofield healing compared with mock healing and a waitlist control group on fatigue in 76 fatigued breast cancer survivors (stages I‐IIIa). Secondary outcomes were diurnal cortisol variability (via estimates of cortisol slope), depression, and quality of life (QOL). Treatment belief was assessed to explore whether belief predicted outcomes. Data were analyzed via hierarchical linear modeling.

RESULTS:

There were no significant differences between biofield healing and mock healing on belief; 75% thought they received biofield healing. Compared with controls, biofield healing significantly decreased total fatigue (P < .0005, Cohen's d = 1.04), as did mock healing (P = .02, Cohen's d = 0.68), with no significant differences between biofield healing and mock healing. Cortisol slope significantly decreased for biofield healing versus both mock healing and control (P < .04 in both cases; Cohen's d = 0.58). Belief predicted changes in QOL over and above group (P = .004, Cohen's d = 0.84). Belief did not impact fatigue or cortisol variability.

CONCLUSIONS:

Nonspecific factors are important in responses to biofield interventions for fatigue. Belief predicts QOL responses but not fatigue or cortisol variability. Biofield therapies increase cortisol variability independent of belief and other nonspecific factors. There is a need to further examine the effects of specific processes of biofield healing on outcomes for cancer populations. Cancer 2012;. © 2011 American Cancer Society.     

Effects of resistance exercise on fatigue and quality of life in breast cancer patients undergoing adjuvant chemotherapy: A randomized controlled trial

Multiple exercise interventions have shown beneficial effects on fatigue and quality of life (QoL) in cancer patients, but various psychosocial interventions as well. It is unclear to what extent the observed effects of exercise interventions are based on physical adaptations or rather on psychosocial factors associated with supervised, group‐based programs. It needs to be determined which aspects of exercise programs are truly effective. Therefore, we aimed to investigate whether resistance exercise during chemotherapy provides benefits on fatigue and QoL beyond potential psychosocial effects of group‐based interventions. One‐hundred‐one breast cancer patients starting chemotherapy were randomly assigned to resistance exercise (EX) or a relaxation control (RC) group. Both interventions were supervised, group‐based, 2/week over 12 weeks. The primary endpoint fatigue was assessed with a 20‐item multidimensional questionnaire, QoL with the EORTC QLQ‐C30/BR23. Analyses of covariance for individual changes from baseline to Week 13 were calculated. In RC, total and physical fatigue worsened during chemotherapy, whereas EX showed no such impairments (between‐group p = 0.098 and 0.052 overall, and p = 0.038 and 0.034 among patients without severe baseline depression). Differences regarding affective or cognitive fatigue were not significant. Benefits of EX were also seen to affect role and social function. Effect sizes were between 0.43 and 0.48. Explorative analyses indicated significant effect modification by thyroxin use (p‐interaction = 0.044). In conclusion, resistance exercise appeared to mitigate physical fatigue and maintain QoL during chemotherapy beyond psychosocial effects inherent to supervised group‐based settings. Thus, resistance exercise could be an integral part of supportive care for breast cancer patients undergoing chemotherapy.     

Impact of two nurse‐led interventions targeting diet among breast cancer survivors: Results from a randomized controlled trial

Breast cancer is the most common neoplasm among women worldwide. Improvements in early detection and treatment have resulted in improved survival rates; however, the continuation of unhealthy behaviours after diagnosis can increase the risk of second primary tumours. The aim of the study was to evaluate the effectiveness of two nurse‐led health education interventions aiming at improving dietary behaviours among women diagnosed with breast cancer. Participants (n = 492) were included in a double‐blind randomized controlled trial with three arms: a control group received usual care; women in the first intervention group received a booklet containing dietary advice; women in the second intervention group received the same booklet plus a tailored telephone intervention delivered by a trained nurse. One year after the intervention, women in both intervention groups were more likely to adhere to the recommendation of decreasing the consumption of animal fats compared with the control group (OR:5.0; 95% CI:1.5–16.9 and OR:6.6; 95% CI:2.0–22.6, respectively). Moreover, compared with the control group, the adjusted probability of eating the recommended amount of fruit and vegetables was higher in the second intervention group (OR:2.7; 95% CI:1.4–5.3). In summary, the booklet containing dietary advice for breast cancer survivors, either alone or supplemented with a nurse‐led telephone intervention, was effective in promoting adherence to diet recommendations.     

A randomized controlled trial to evaluate the effectiveness of a brief, behaviorally oriented intervention for cancer-related fatigue

BACKGROUND: It has been shown that nonpharmacologic interventions are effective management techniques for cancer-related fatigue (CRF) in cancer survivors. However, few studies have investigated their effectiveness in patients who are receiving chemotherapy. In this study, the authors tested the effectiveness of a brief behaviorally oriented intervention in reducing CRF and improving physical function and associated distress in individuals who were receiving chemotherapy. METHODS: For this randomized controlled trial, 60 patients with cancer were recruited and received either usual care or the intervention. The intervention was delivered on an individual basis on 3 occasions over a period from 9 weeks to 12 weeks, and the objective of the intervention was to alter fatigue-related thoughts and behavior. Primary outcomes were assessed as follows: CRF using the Visual Analogue Scale-Global Fatigue; physical functioning using the European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 Questionnaire, and CRF-associated distress using the Fatigue Outcome Measure. Assessments were made on 4 occasions: at baseline (T0), at the end of chemotherapy (T1), 1 month after chemotherapy (T2), and 9 months after recruitment (T3). Normally distributed data were analyzed using t tests and random-slope/random-intercept mixed models. RESULTS: The intervention demonstrated a trend toward improved CRF, although this effect was reduced once confounders had been controlled statistically. There was a significant improvement in physical functioning (coefficient, 10.0; 95% confidence interval, 2.5-17.5; P = .009), and this effect remained once the confounding effects of mood disturbance and comorbid disorders were controlled statistically. No decrease in fatigue-related distress was detected. CONCLUSIONS: The behaviorally oriented intervention brought about significant improvements in physical functioning, indicated a trend toward improved CRF, but detected no effect for fatigue-related distress.     

Resistance training improves fatigue and quality of life in previously sedentary breast cancer survivors: a randomised controlled trial

The primary aim of this study was to evaluate the benefits of resistance training (RT) on quality of life (QOL) and fatigue in breast cancer survivors as an adjunct to usual care. We recruited 39 women who had survived breast cancer [mean age (y) 51.9 ± 8.8; time since diagnosis (m) 11.6 ± 13.2]. Primary outcomes were fatigue as assessed by the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT) scale and QOL as assessed by the Functional Assessment of Cancer Therapy – General (FACT‐G) scale. ANCOVA was used to assess the change in the primary outcomes while controlling for baseline values, with effect sizes (ES) displayed as partial Eta squared. The experimental group received supervised RT 3 days per week in a university clinic for 16 weeks. Perceptions of fatigue improved significantly in the RT group compared to controls [mean (SD) 6.7 (7.5) points vs. 1.5 (3.7) points], (P = 0.006, ES = 0.20) as did QOL [6.9 (8.5) points vs. 1.6 (4.4) points], (P = 0.015, ES = 0.16). We demonstrated both statistically and clinically important improvements in fatigue and QOL in response to RT in breast cancer survivors.     

负载自体热休克凋亡癌细胞抗原的DC治疗三阴性乳腺癌的随机对照多中心临床试验

评价自体热休克凋亡肿瘤细胞抗原负载DC对Ⅰ到Ⅳ期ER、PR、Her2三阴性乳腺癌（triple-negative breast cancer, TNBC）患者治疗的疗效和患者对该治疗的耐受性。方法：入选南京、常州、无锡三地3个医院的TNBC患者168例,按照2∶1的比例使用随机数字表将患者随机分组为DC免疫组112例、对照组56例。DC疫苗治疗每周1次,4次为1个疗程,疗程间间隔1个月,共3个疗程。疫苗治疗前、后检测患者外周血中细胞因子谱（IL-2、IL-10、IL-12、TNF-α和IFN-γ）水平和肿瘤特异性CD8+IFNγ+T细胞比例以及进行DTH试验。末次治疗后每3个月随访1次,随访2年,统计患者疾病无进展生存率（PFSR）。结果：Ⅰ~Ⅲ期TNBC患者DC免疫治疗1个疗程后,IL-2、TNF-α和IFN-γ水平即较治疗前（基线）显著升高（PIL-2=0.038 4、PTNF-α=0023 7、PIFN-γ=0.022 1）,且随疗程增加其水平不断升高;而Ⅳ期TNBC患者治疗3个疗程后细胞因子水平均无明显提高。Ⅰ~Ⅲ期TNBC患者外周血CD8+IFN-γ+T细胞比例提升速度与幅度较为缓慢,3个疗程后提升幅度才显示有统计学意义（P<0.05）。患者的DTH试验阳性率伴随疗程数的增加而提升,两者呈正相关关系（r=0.973）;早期（Ⅰ期和Ⅱ期）TNBC患者DTH平均阳性率明显高于中晚期患者（Ⅲ期和Ⅳ期）。2年随访期内Ⅰ~Ⅱ期TNBC患者病情均较稳定,生存率100%;Ⅲ~Ⅳ期TNBC患者DC治疗组PFSR明显高于对照组（71.43% vs 32.73%,P<0.05）。Ⅰ~Ⅳ期DTH阳性患者的PFSR明显高于DTH阴性患者（87.30% vs 51.02%,P<0.05）。治疗组112例TNBC患者对DC治疗耐受良好,未发现Ⅱ级以上不良反应。结论：自体热休克凋亡肿瘤细胞抗原负载DC可有效诱导早期TNBC患者产生Th1型免疫应答反应,分泌高水平Th1型抗瘤因子,3个疗程后可激发明显的肿瘤抗原特异性CTL反应,DTH试验可作为DC免疫有效性的评价指标之一。该DC免疫治疗方法可抑制晚期TNBC患者疾病进展,从而提高PFSR,患者耐受性良好。     

Prolonged impact of chemotherapy on fatigue in breast cancer survivors: a longitudinal comparison with radiotherapy-treated breast cancer survivors and noncancer controls

BACKGROUND:

In this study, the authors examined the influence of prior treatment on the course of fatigue in breast cancer survivors. Patients who received chemotherapy were expected to have greater fatigue than patients who received radiotherapy and noncancer controls 6 months after the completion of treatment, but they were expected to recover to levels similar to those of the other 2 groups 3 years later.

METHODS:

Patients with stage 0 through II breast cancer completed the Fatigue Symptom Inventory (FSI) and the Profile of Mood States Fatigue Scale (POMS‐FAT) 6 months (T1) and 42 months (T2) after completing chemotherapy with or without radiotherapy (the CT group; n = 103) or radiotherapy only (the RT group; n = 102). An age‐matched group of women with no history of cancer (the NC group; n = 193) was assessed over a similar interval.

RESULTS:

A significant (P = .041) group × time effect for FSI severity scores revealed that fatigue worsened over time in the CT group but remained stable and lower in the RT and NC groups. There also were significant group effects for FSI days (P < .001) and POMS‐FAT (P = .010) scores, indicating that fatigue was significantly greater across time in the CT group than in the NC group (POMS‐FAT) or the RT and NC groups (FSI days).

CONCLUSIONS:

Contrary to expectations, fatigue did not diminish over time in patients with breast cancer who received chemotherapy. This finding has important implications for patient education and for fatigue monitoring during follow‐up. The authors concluded that future research should seek to examine possible mechanisms to explain the apparent prolonged impact of chemotherapy on fatigue in breast cancer survivors. Cancer 2012. © 2011 American Cancer Society.     

Increased breast cancer screening and downstaging in Colombian women: A randomized trial of opportunistic breast‐screening

The lack of breast cancer screening in low and middle‐income countries results in later stage diagnosis and worsened outcomes for women. A cluster randomized trial was performed in Bogotá, Colombia between 2008 and 2012 to evaluate effects of opportunistic breast cancer screening. Thirteen clinics were randomized to an intervention arm and 13 to a control arm. Physicians in intervention clinics were instructed to perform clinical breast examination on all women aged 50–69 years attending clinics for non‐breast health issues, and then refer them for mammographic screening. Physicians in control clinics were not explicitly instructed to perform breast screening or mammography referrals, but could do so if they thought it indicated (“usual care”). Women were followed for 2‐years postrandomization. 7,436 women were enrolled and 7,419 (99.8%) screened in intervention clinics, versus 8,419 enrolled and 1,108 (13.1%) screened in control clinics. Incidence ratios (IR) of early, advanced and all breast cancers were 2.9 (95% CI 1.1–9.2), 1.0 (0.3–3.5) and 1.9 (0.9–4.1) in the first (screening) year of the trial, and the cumulative IR for all breast cancers converged to 1.4 (0.7–2.8) by the end of follow‐up (Year 2). Eighteen (69.2%) of 26 women with early stage disease had breast conservation surgery (BCS) versus 6 (42.5%) of 14 women with late‐stage disease (p = 0.02). Fifteen (68.2%) of 22 women with breast cancer in the intervention group had BCS versus nine (50.0%) of 18 women in the control group (p = 0.34). Well‐designed opportunistic clinic‐based breast cancer screening programs may be useful for early breast cancer detection in LMICs.     

Health management of breast cancer survivors

Breast cancer is defined as a chronic disease. Increasing amounts of attention have been paid to the health management of breast cancer survivors. An important issue is how to find the most appropriate method of follow-up in order to detect long-term complications of treatment, local recurrence and distant metastasis and to administer appropriate treatment to the survivors with recurrence in a timely fashion. Different oncology organizations have published guidelines for following up breast cancer survivors. However, there are few articles on this issue in China. Using the published follow-up guidelines, we analyzed their main limitations and discussed the content, follow-up interval and economic benefits of following up breast cancer survivors in an effort to provide suggestions to physicians. Based on a large number of clinical trials, we discussed the role of physical examination, mammography, liver echograph, chest radiography, bone scan and so on. We evaluated the effects of the above factors on detection of distant disease, survival time, improvement in quality of life and time to diagnosis of recurrence. The results of follow-up carried out by oncologists and primary health care physicians were compared. We also analyzed the correlation factors for the cost of such follow-up. It appears that follow-up for breast cancer survivors can be carried out effectively by trained primary health care physicians. If anything unusual arises, the patients should be transferred to specialists.     

Physical exercise for cancer patients with advanced disease: a randomized controlled trial

Background.

Physical exercise can improve cancer patients'' functioning and reduce their symptom levels. A randomized, controlled trial was launched to test the hypothesis that physical exercise reduces fatigue and improves physical performance in cancer patients with advanced and incurable disease.

Methods.

Cancer patients (n = 231) with a life expectancy ≤2 years were randomized to a physical exercise group (PEG, n = 121) or a control usual care group (UCG, n = 110). The PEG exercised under supervision 60 minutes twice a week for 8 weeks. Assessments were performed before and after the intervention. The primary outcome was physical fatigue (PF) measured by the Fatigue Questionnaire. Physical performance was a secondary outcome measured by the Shuttle Walk Test (SWT) and hand grip strength (HGS) test. Analyses were performed after multiple imputations for missing data. The trial is registered with ClinicalTrials.gov (identifier, {"type":"clinical-trial","attrs":{"text":"NCT00397774","term_id":"NCT00397774"}}NCT00397774).

Findings.

Thirty-six percent of the PEG were lost to follow-up compared with 23% of the UCG, primarily as a result of disease progression. Seventy-eight PEG and 85 UCG patients completed the intervention. Analyses showed no significant between-group effects in PF. However, clinically and statistically significant between-group effects were found for the SWT and HGS test.

Interpretation.

Fatigue was not reduced but physical performance (SWT and HGS test) was significantly improved after 8 weeks of physical exercise. Physical exercise might therefore be a suitable approach for maintaining physical capacity in cancer patients with incurable and advanced disease.