The effect of resistance training on muscle strength and physical function in older, postmenopausal breast cancer survivors: a randomized controlled trial

Introduction  

Older breast cancer survivors (BCS) report more falls and functional limitations than women with no cancer history. Exercise training could reduce risk factors for future falls and disability.     

Advanced cognitive training for breast cancer survivors: a randomized controlled trial

The purpose of this study was to evaluate the preliminary efficacy and satisfaction/acceptability of training in memory or speed of processing versus wait-list control for improving cognitive function in breast cancer survivors. 82 breast cancer survivors completed a three-group randomized, controlled trial. Primary outcomes were objective neuropsychological tests of memory and speed of processing. Secondary outcomes were perceived cognitive functioning, symptom distress (mood disturbance, anxiety, and fatigue), quality of life, and intervention satisfaction/acceptability. Data were collected at baseline, post-intervention, and 2-month follow-up. Using repeated-measures mixed-linear ANCOVA models, each intervention was compared to wait-list control while adjusting for age, education, and baseline measures. The effect sizes for differences in means and the reliable improvement percentage were reported. The results show that domain-specific effects were seen for both interventions: memory training improved memory performance at 2-month follow-up (p?=?0.036, d?=?0.59); speed of processing training improved processing speed post-intervention (p?=?0.040, d?=?0.55) and 2-month follow-up (p?=?0.016; d?=?0.67). Transfer effects to non-trained domains were seen for speed of processing training with improved memory post-intervention (p?=?0.007, d?=?0.75) and 2-month follow-up (p?=?0.004, d?=?0.82). Both interventions were associated with improvements in perceived cognitive functioning, symptom distress, and quality of life. Ratings of satisfaction/acceptability were high for both interventions. It was concluded that while both interventions appeared promising, speed of processing training resulted in immediate and durable improvements in objective measures of processing speed and verbal memory. Speed of processing training may have broader benefits in this clinical population.     

Yoga for persistent fatigue in breast cancer survivors: a randomized controlled trial

BACKGROUND:

Cancer‐related fatigue afflicts up to 33% of breast cancer survivors, yet there are no empirically validated treatments for this symptom.

METHODS:

The authors conducted a 2‐group randomized controlled trial to determine the feasibility and efficacy of an Iyengar yoga intervention for breast cancer survivors with persistent post‐treatment fatigue. Participants were breast cancer survivors who had completed cancer treatments (other than endocrine therapy) at least 6 months before enrollment, reported significant cancer‐related fatigue, and had no other medical conditions that would account for fatigue symptoms or interfere with yoga practice. Block randomization was used to assign participants to a 12‐week, Iyengar‐based yoga intervention or to 12 weeks of health education (control). The primary outcome was change in fatigue measured at baseline, immediately post‐treatment, and 3 months after treatment completion. Additional outcomes included changes in vigor, depressive symptoms, sleep, perceived stress, and physical performance. Intent‐to‐treat analyses were conducted with all randomized participants using linear mixed models.

RESULTS:

Thirty‐one women were randomly assigned to yoga (n = 16) or health education (n = 15). Fatigue severity declined significantly from baseline to post‐treatment and over a 3‐month follow‐up in the yoga group relative to controls (P = .032). In addition, the yoga group had significant increases in vigor relative to controls (P = .011). Both groups had positive changes in depressive symptoms and perceived stress (P < .05). No significant changes in sleep or physical performance were observed.

CONCLUSIONS:

A targeted yoga intervention led to significant improvements in fatigue and vigor among breast cancer survivors with persistent fatigue symptoms. Cancer 2012. © 2011 American Cancer Society.     

Managing menopausal symptoms in breast cancer survivors: results of a randomized controlled trial

BACKGROUND: Menopausal symptoms (e.g., hot flashes, vaginal dryness, and stress urinary incontinence) are very common in breast cancer survivors and cannot be managed with standard estrogen replacement therapy (ERT) in these patients. The purpose of this study was to test the efficacy of a comprehensive menopausal assessment (CMA) intervention program in achieving relief of symptoms, the improvement in quality of life (QOL), and sexual functioning in breast cancer survivors. METHODS: Using a two-group, randomized controlled design, we assigned 76 postmenopausal breast cancer survivors with at least one severe target symptom either to the intervention group or to a usual-care group. Seventy-two women were evaluable at the end of the study period. The CMA intervention, delivered by a nurse practitioner, focused on symptom assessment, education, counseling and, as appropriate, specific pharmacologic and behavioral interventions for each of the three target symptoms. Psychosocial symptoms were assessed with the use of a self-report screening instrument, and distressed women were referred for counseling if needed. The intervention took place over a 4-month period. Outcomes measured were scores on a composite menopausal symptom scale, the RAND Short Form Health Survey Vitality Scale, and the Cancer Rehabilitation Evaluation System (CARES) Sexual Functioning Scale at baseline and at 4-month follow-up. All statistical tests were two-sided and were performed at the alpha =. 05 significance level. RESULTS: Patients receiving the intervention demonstrated statistically significant improvement (P =.0004) in menopausal symptoms but no significant change in vitality (P =.77). Sexual functioning was statistically significantly improved (P =.04) in the treatment group compared with the usual-care group. CONCLUSIONS: A clinical assessment and intervention program for menopausal symptom management in breast cancer survivors is feasible and acceptable to patients, leading to reduction in symptoms and improvement in sexual functioning. Measurable improvement in a general QOL measure was not demonstrated.     

Randomized controlled trial of exercise training in postmenopausal breast cancer survivors: cardiopulmonary and quality of life outcomes.

PURPOSE: To determine the effects of exercise training on cardiopulmonary function and quality of life (QOL) in postmenopausal breast cancer survivors who had completed surgery, radiotherapy, and/or chemotherapy with or without current hormone therapy use. METHODS: Fifty-three postmenopausal breast cancer survivors were randomly assigned to an exercise (n = 25) or control (n = 28) group. The exercise group trained on cycle ergometers three times per week for 15 weeks at a power output that elicited the ventilatory equivalent for carbon dioxide. The control group did not train. The primary outcomes were changes in peak oxygen consumption and overall QOL from baseline to postintervention. Peak oxygen consumption was assessed by a graded exercise test using gas exchange analysis. Overall QOL was assessed by the Functional Assessment of Cancer Therapy-Breast scale. RESULTS: Fifty-two participants completed the trial. The exercise group completed 98.4% of the exercise sessions. Baseline values for peak oxygen consumption (P =.254) and overall QOL (P =.286) did not differ between groups. Peak oxygen consumption increased by 0.24 L/min in the exercise group, whereas it decreased by 0.05 L/min in the control group (mean difference, 0.29 L/min; 95% confidence interval [CI], 0.18 to 0.40; P <.001). Overall QOL increased by 9.1 points in the exercise group compared with 0.3 points in the control group (mean difference, 8.8 points; 95% CI, 3.6 to 14.0; P =.001). Pearson correlations indicated that change in peak oxygen consumption correlated with change in overall QOL (r = 0.45; P <.01). CONCLUSION: Exercise training had beneficial effects on cardiopulmonary function and QOL in postmenopausal breast cancer survivors.     

Osteoporosis and rate of bone loss among postmenopausal survivors of breast cancer

BACKGROUND: Breast cancer diagnosis and treatment may put women at higher risk for osteoporosis in later life. METHODS: In a subgroup of participants in the Women's Health Initiative Observational Study, authors of the current study investigated differences in bone mineral density (BMD, measured by dual-energy x-ray absorptiometry) between breast cancer survivors (n = 209) and a noncancer reference group (n = 5759). RESULTS: In comparison to the reference group, breast cancer survivors had significantly lower total body BMD value (0.989 vs. 1.013 g/cm(2), P = 0.001) and total hip BMD value (0.823 vs. 0.845 g/cm(2), P = 0.02) at baseline after adjustment for age, race/ethnicity, years since menopause, and clinical center. These lower BMD levels were largely explained by lower usage of hormone therapy (HT) among survivors: after additional statistical adjustment for HT, hip BMD values were 0.834 versus 0.844 g/cm(2) (P = 0.26), and total body values were 1.005 versus 1.013 g/cm(2) (P = 0.33) for survivors and reference women, respectively. More than 77% of survivors with osteoporosis were undiagnosed by their healthcare providers, and this was similar to the undiagnosed rate in the reference group (85.7%). Longitudinally, breast cancer survivors in this study did not demonstrate an accelerated rate of bone loss compared with the reference population. CONCLUSIONS: Associated with lower HT usage, postmenopausal survivors of breast cancer were more likely to have low BMD in comparison to other women of the same age; and many of these survivors with osteoporosis were undiagnosed.     

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 exercise training on fasting insulin, insulin resistance, insulin-like growth factors, and insulin-like growth factor binding proteins in postmenopausal breast cancer survivors: a randomized controlled trial.

Insulin, insulin-like growth factors (IGFs) I and II, and IGF binding proteins (IGFBPs) 1 and 3 have been implicated in breast cancer outcomes. We conducted a randomized controlled trial to determine the physiological effects of exercise training on changes in these biological markers in postmenopausal breast cancer survivors. Fifty-three postmenopausal breast cancer survivors were randomly assigned to an exercise (n = 25) or control group (n = 28). The exercise group trained on cycle ergometers three times per week for 15 weeks. The control group did not train. End points included changes in fasting insulin, glucose, insulin resistance, IGF-I, IGF-II, IGFBP-1, IGFBP-3, and IGF-I:IGFBP-3 molar ratio between baseline and week 15. All of the statistical tests were two-sided (alpha = 0.05). Fifty-two participants completed the trial. The exercise group completed 44.3 of 45 (98.4%) prescribed exercise sessions. Baseline hormone concentrations did not differ between groups except that IGF-II was higher in the exercise group (P = 0.011). No significant differences between groups were observed for changes in fasting insulin (+6.3 pmol/liter; P = 0.941), glucose (+0.09 mmol/liter; P = 0.824), insulin resistance (+0.4; P = 0.247), IGF-II (-40.7 ng/ml; P = 0.101), or IGFBP-1 (+1.4 ng/ml; P = 0.774). However, significant differences between groups were observed for changes in IGF-I (-7.4 ng/ml; P = 0.045), IGFBP-3 (+180.5 ng/ml; P = 0.021), and IGF-I:IGFBP-3 molar ratio (-0.006; P = 0.017). Exercise training had significant physiological effects on IGF-I, IGFBP-3, and IGF-I:IGFBP-3 molar ratio in postmenopausal breast cancer survivors. The clinical implications of these findings remain to be defined.     

Adherence to a randomized controlled trial of aerobic exercise in breast cancer survivors: the Yale exercise and survivorship study

Purpose  To examine predictors of exercise adherence in breast cancer survivors. Methods  Seventy-five breast cancer survivors were randomly assigned to exercise (n = 37) or usual care (n = 38). Demographic, prognostic, physiologic, and psychosocial information was collected at baseline and 6 months. The exercise goal was 30 min of exercise 5 days/week for 6 months. Results  Women randomized to exercise participated in moderate-intensity recreational exercise for 123 ± 52 min/week (81% of the prescribed 150 min/week) over 6 months. Baseline variables associated with better adherence were lower body mass index (BMI), smaller waist circumference, higher amounts of physical activity 6 months prior to enrollment, being in the preparation vs. contemplation Stage of Change and higher FACT-B breast cancer subscale score. After adjusting for these variables, lower BMI and higher Stage of Change continued to be associated with better adherence (p < 0.05). Conclusions  Future studies of exercise and breast cancer prognosis should target obese women for participation, as well as women just beginning to contemplate participation and its benefits after a cancer diagnosis.     

A pilot randomized trial to prevent sexual dysfunction in postmenopausal breast cancer survivors starting adjuvant aromatase inhibitor therapy

Purpose

A randomized pilot trial evaluated the hypothesis that early intervention lessens sexual dysfunction in the first year on aromatase inhibitors. A secondary aim was comparing the efficacy of two vaginal moisturizers.

Methods

Fifty-seven postmenopausal women with early stage breast cancer starting aromatase inhibitors were randomized to three treatment groups. All received a handout on managing sexual and other side effects. The Usual Care group received no additional therapy. The Active Treatment groups received a 6-month supply of a vaginal moisturizer (hyaluronic acid-based in Active Group-H and prebiotic in Active Group-P) and a vaginal lubricant and dilator, plus access to an educational website and phone coaching. Questionnaires completed at baseline, 6, and 12 months included the Female Sexual Function Index (FSFI), Menopausal Sexual Interest Questionnaire (MSIQ), Female Sexual Distress Scale-Revised (FSDS-R), and a menopausal symptom scale.

Results

Forty-nine women (86%) provided follow-up data. Mean age was 59 and 77% were non-Hispanic Caucasian. Sexual function was impaired at baseline, but remained stable over 12 months for all groups. The combined active treatment group had less dyspareunia (P = 0.07) and sexual distress (P = 0.02) at 6 months than the Usual Care group. At 6 months, the Active-H group improved significantly more than the Active-P group on FSFI total score (P = 0.04).

Conclusions

Sexual counseling helped women maintain stable sexual function on aromatase inhibitors. Active intervention resulted in better outcomes at 6 months.

Implications for Cancer Survivors

This promising pilot trial suggests a need for more research on preventive counseling to maintain sexual function during aromatase inhibitor treatment.

     

Fatigue reduction diet in breast cancer survivors: a pilot randomized clinical trial

Purpose

Fatigue is a prevalent and burdensome effect of breast cancer. Fatigue has been linked to chronic inflammation, and diets high in antioxidant nutrients have been associated with lesser prevalence and severity of fatigue. Studies are needed, however, to test if antioxidant-rich diets could improve fatigue.

Methods

Pilot, randomized, trial conducted between January 2014 and April 2015, to investigate if a 3-month diet rich in fruit, vegetables, whole grains, and omega-3 fatty acid-rich foods, named the fatigue reduction diet (FRD), improved fatigue and sleep compared to an attention control, named the general health curriculum (GHC). 30 stage 0 to III breast cancer survivors, who had completed cancer treatments, were randomized: 15 receiving the FRD and 15 the GHC. Primary outcome was change in fatigue, as measured by the brief fatigue Inventory, from baseline to 3 months analyzed using linear mixed models. Secondary analyses were changes in sleep quality, serum carotenoids, and fatty acids.

Results

From baseline to 3-month fatigue improved by 44 ± 39% in FRD compared to 8 ± 34% in GHC (p = 0.01); sleep quality improved by 2.5 ± 3.3 points in FRD, and diminished by 0.9 ± 2.3 in GHC (p = 0.03); serum total carotenoids (p < 0.01), β-cryptoxanthin (p = 0.02), lutein (p = 0.05), zeaxanthin (p = 0.01), lycopene (p = 0.05), omega-3 fatty acids (p < 0.01), and ratio of omega-3:omega-6 fatty acids (p = 0.02) were significantly increased, and percent saturated fatty acids were decreased (p = 0.04) in FRD; γ-tocopherol was significantly increased in GHC (p = 0.03), and there was a significant visit by group difference for α-carotene between the study groups (p = 0.05).

Conclusions

The FRD intervention improved fatigue and sleep in breast cancer survivors compared to the GHC. FRD diet could provide a non-toxic treatment strategy for persistent fatigue.

     

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.     

Adjuvant tamoxifen in postmenopausal breast cancer: Preliminary results of a randomized trial

Summary Between May 1978 and March 1982, 179 postmenopausal women with operable breast cancer were randomized to receive either adjuvant tamoxifen, 40 mg daily for three years (TAM group), or no further treatment (controls).The difference in five-year survival rates (61% in the control group, 72% in the TAM group) was not statistically significant. However, there was a significant improvement in disease-free survival in the TAM group (61%) relative to the controls (44%) (p = 0.008). In estrogen receptor positive patients, tamoxifen improved both the disease-free rate (47% controls, 80% with tamoxifen) and the survival rate (63% to 83%). Similar results were observed in progesterone receptor positive patients. In patients that were estrogen receptor negative, tamoxifen modified neither the survival rate nor the disease-free interval.     

Effect of soy phytoestrogens on hot flashes in postmenopausal women with breast cancer: a randomized, controlled clinical trial.

PURPOSE: Vasomotor symptoms, such as hot flashes and night sweats, in breast cancer survivors are often worsened by chemotherapy and tamoxifen, and/or the discontinuation of hormone replacement therapy at diagnosis. This study evaluated the acceptability and effectiveness of a soy beverage containing phytoestrogens as a treatment for hot flashes in postmenopausal women with breast cancer. METHODS: A randomized, placebo-controlled, double-blind clinical trial was conducted in postmenopausal women with moderate hot flashes who were previously treated for early-stage breast cancer. Women were stratified for tamoxifen use and randomized to a soy beverage (n = 59) containing 90 mg of isoflavones or to a placebo rice beverage (n = 64). Women recorded the number and severity of hot flashes daily with a daily menopause diary for 4 weeks at baseline and for 12 weeks while consuming 500 mL of a soy or placebo beverage. RESULTS: There were no significant differences between the soy and placebo groups in the number of hot flashes or hot flash scores. However, presumably because of a strong placebo effect, both groups had significant reductions in hot flashes. Mild gastrointestinal side effects were experienced by both groups but occurred with greater frequency and severity with soy. The mean serum genistein concentration at 6 weeks was significantly higher in women who consumed soy (0.61 +/- 0.43 micromol/L) compared with placebo (0.43 +/- 0.37 micromol/L) (P =.02). Overall acceptability and compliance were high and similar in both groups. CONCLUSION: The soy beverage did not alleviate hot flashes in women with breast cancer any more than did a placebo. Future research into other compounds is recommended to identify safe and effective therapies for hot flashes in breast cancer survivors.