Exercise Program for Breast Cancer Fatigue
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Virtua Health, Inc.
Disqualifiers: Psychotic disorders, Dementia, Chronic fatigue, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?Assess feasibility of home exercise in reducing fatigue in subjects with breast cancer receiving curative intent chemotherapy. Subjects are randomized to control (no exercise) or intervention group (exercise). The PRO-CTCAE tool and FACIT Fatigue Scale are used to collect patient reported outcomes. Subjects submit data via mobile phone, tablet or computer. Assessments are weekly during chemotherapy (10-20 wks), at end of chemotherapy and 1, 3 and 6 months after chemotherapy.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training for managing fatigue in breast cancer patients?
Research shows that exercise can significantly reduce fatigue in breast cancer patients. Studies have found that a home-based moderate-intensity walking program can effectively lower fatigue levels during cancer treatment.
12345Is exercise safe for breast cancer patients experiencing fatigue?
Exercise programs, including aerobic and resistance exercises, have been studied in breast cancer patients and are generally considered safe. These programs can help reduce fatigue and improve physical function without significant safety concerns.
25678How does the exercise treatment for breast cancer fatigue differ from other treatments?
The exercise program for breast cancer fatigue is unique because it focuses on physical activity, which can improve both physical and psychological health by being enjoyable, skill-developing, and socially interactive. Unlike medications, this treatment involves moderate-intensity aerobic and resistance exercises, which can be tailored to individual needs and conditions, such as fatigue and nausea, to enhance overall well-being.
2691011Eligibility Criteria
This trial is for English-speaking women over 18 with breast cancer, planning to undergo at least 4 chemotherapy cycles. They must be able to exercise (if cleared by a cardiologist), have an ECOG score <3, and own a device like a smartphone for reporting. It's not for those with exercise contraindications or certain medical/psychiatric conditions.Inclusion Criteria
I can take care of myself but may not be able to do heavy physical work.
English-speaking with sufficient vision/hearing or family support
I am older than 18 years.
+4 more
Exclusion Criteria
I have heart artery disease not approved by a heart doctor.
You have a reason that makes it unsafe for you to exercise.
Medical or psychiatric conditions (beyond those related to breast cancer and its treatment) that would impair our ability to test study hypotheses (psychotic disorders, dementia, inability to give informed consent or follow instructions)
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Chemotherapy
Participants receive curative-intent chemotherapy while being assessed weekly for cancer-related fatigue and other symptoms
10-20 weeks
Weekly assessments via mobile phone, tablet, or computer
Follow-up
Participants are monitored for safety and effectiveness after chemotherapy, with assessments at 1, 3, and 6 months
6 months
Assessments at 1, 3, and 6 months post-chemotherapy
Participant Groups
The study tests if home exercises can reduce fatigue in breast cancer patients during chemotherapy. Participants are randomly assigned to either control (no exercise) or intervention (exercise) groups, and they report their fatigue levels using specific tools online throughout the treatment period.
2Treatment groups
Experimental Treatment
Active Control
Group I: ExerciseExperimental Treatment1 Intervention
Intervention: Subject will be assessed by a Physical Therapist. Based on the assessment, the Physical Therapist will provide the patient with a home-based exercise program including core exercises as follows: Core Stabilization, core extension, leg extensions, squats with and without weights, shoulder and arm exercises. Patients will be asked to complete a symptom survey weekly via a web-based platform for tracking cancer and treatment-related symptoms and fatigue.
Group II: ControlActive Control1 Intervention
Subject will not be provided an exercise program but will be asked to complete the symptom survey weekly via a web-based platform for tracking cancer and treatment-related symptoms and fatigue.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Virtua HealthVoorhees, NJ
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Who Is Running the Clinical Trial?
Virtua Health, Inc.Lead Sponsor
Carevive Systems, Inc.Industry Sponsor
References
Effects of exercise interventions on cancer-related fatigue in breast cancer patients: an overview of systematic reviews. [2023]This overview of systematic reviews aims to critically appraise and consolidate evidence from current systematic reviews (SRs)/meta-analyses on the effects of exercise interventions on cancer-related fatigue (CRF) in breast cancer patients.
Baseline fatigue in early breast cancer survivors: understanding its prevalence in community-based exercise. [2022]Examine baseline fatigue levels in early-breast cancer survivors (EBCS) compared to inactive controls (CON) and identify associated physical and psychosocial factors with fatigue prior to community-based exercise.
Supervised exercise reduces cancer-related fatigue: a systematic review. [2022]Does supervised physical activity reduce cancer-related fatigue?
Exercise manages fatigue during breast cancer treatment: a randomized controlled trial. [2022]Fatigue is the most prevalent and debilitating symptom experienced by breast cancer patients receiving adjuvant chemotherapy or radiation therapy and few evidence-based treatments are available to manage this distressing side-effect. The purpose of this multi-institutional randomized controlled trial was to determine the effects of exercise on fatigue levels during treatment for breast cancer. Sedentary women (N=119) with Stage 0-III breast cancer receiving outpatient adjuvant chemotherapy or radiation therapy were randomized to a home-based moderate-intensity walking exercise program or to usual care for the duration of their cancer treatment. Of participants randomized to exercise, 72% adhered to the exercise prescription; 61% of the usual care group adhered. The intention-to-treat analysis revealed no group differences in part because of a dilution of treatment effect as 39% of the usual care group exercised and 28% of the exercise group did not. When exercise participation was considered using the data analysis method of instrumental variables with principal stratification, a clinically important and statistically significant (p=0.03) effect of exercise on pretest-to-posttest change in fatigue levels was demonstrated. Adherence to a home-based moderate-intensity walking exercise program may effectively mitigate the high levels of fatigue prevalent during cancer treatment.
Exercise for fatigue in breast cancer patients: An umbrella review of systematic reviews. [2022]To evaluate evidence from published systematic reviews about the effectiveness of exercise interventions on fatigue management in breast cancer patients.
Effects of an 18-week exercise programme started early during breast cancer treatment: a randomised controlled trial. [2022]Exercise started shortly after breast cancer diagnosis might prevent or diminish fatigue complaints. The Physical Activity during Cancer Treatment (PACT) study was designed to primarily examine the effects of an 18-week exercise intervention, offered in the daily clinical practice setting and starting within 6 weeks after diagnosis, on preventing an increase in fatigue.
Brief Hospital Supervision of Exercise and Diet During Adjuvant Breast Cancer Therapy Is Not Enough to Relieve Fatigue: A Multicenter Randomized Controlled Trial. [2021]Supervised exercise dietary programs are recommended to relieve cancer-related fatigue and weight increase induced by adjuvant treatment of early breast cancer (EBC). As this recommendation lacks a high level of evidence, we designed a multicenter randomized trial to evaluate the impact of an Adapted Physical Activity Diet (APAD) education program on fatigue. We randomized 360 women with EBC who were receiving adjuvant chemotherapy and radiotherapy to APAD or usual care at eight French cancer institutions. Data were collected at baseline, end of chemotherapy, end of radiotherapy, and 6 months post-treatment. The primary endpoint was the general cancer-related fatigue score using the MFI-20 questionnaire. Fatigue correlated with the level of precariousness, but we found no significant difference between the two groups in terms of general fatigue (p = 0.274). The APAD arm has a smaller proportion of patients with confirmed depression at the end of follow-up (p = 0.052). A transient modification in physical activity levels and dietary intake was reported in the experimental arm. However, a mixed hospital- and home-based APAD education program is not enough to improve fatigue caused by adjuvant treatment of EBC. Cancer care centers should consider integrating more proactive diet-exercise supportive care in this population, focusing on precarious patients.
Home-based exercise to alleviate fatigue and improve functional capacity among breast cancer survivors. [2022]This pilot study examined the efficacy of two home-based exercise programs on alleviating fatigue and improving functional capacity in breast cancer survivors. Participants were randomly assigned into one of three groups: aerobic exercise (AE), resistance exercise (RE), or usual care control (CON). After receiving individualized instruction and training, participants assigned to the AE and RE groups were asked to perform the prescribed exercise(s) 3 times per week for 12 weeks at home. Both groups were instructed to keep their perceived exercise intensity in the "fairly light" to "somewhat hard" range using the Borg Perceived Exertion Scale. All participants completed the revised Piper Fatigue Scale (PFS) and the 6-minute walk test (6MWT) at baseline and 12-week post-exercise program. Analysis of pre- and post-training data revealed a significant reduction in fatigue levels on the PFS among participants in the AE group (Z=2.521, one-tailed P=0.006), and a significant improvement in the distance of the 6MWT for the RE group (Z=2.366, one-tailed P=0.009) at the end of 12-week study period. No significant changes in fatigue or functional status were observed in the CON group. Findings provide preliminary support for RE as a viable strategy for improving functional capacity in breast cancer survivors, while AE may be more effective in attenuating cancer-related fatigue. Incorporating RE training for future research may help advance the growing body of knowledge in symptom management for breast cancer survivors.
Does participation in therapeutic exercise programs after finishing oncology treatment still ensure an adequate health status for long-term breast cancer survivors? A ≥ 5 years follow-up study. [2023]The aims of this study were to evaluate whether the effects of two therapeutic exercise programs are sustained over time (≥ 5 years) in long-term breast cancer survivors (LTBCS). Second, to determine the influence of the current level of physical activity (PA) performed on cancer-related fatigue (CRF) that these patients may present ≥5 years later.
Can a multimodal mind-body program enhance the treatment effects of physical activity in breast cancer survivors with chronic tumor-associated fatigue? A randomized controlled trial. [2014]Background. Chronic fatigue is one of the most restricting symptoms following primary breast cancer treatment, but clinical studies on symptom management are rare. The objective was to evaluate the impact of a multimodal mind-body program (MMMT), including moderate physical activity as compared with a walking intervention alone, on chronic fatigue symptoms of women with stage I to IIIA breast cancer.
Exercise for breast cancer survivors: research evidence and clinical guidelines. [2010]Exercise can have significant benefits for breast cancer survivors during and after treatment. The general aerobic prescription is for moderate-intensity activity (50% to 75% heart rate reserve), 3 to 5 days per week, 20 to 60 minutes per session. Resistance training should also be incorporated into the programs. Psychological health is optimized by exercise that is enjoyable, develops new skills, incorporates social interaction, and takes place in a mind- and spirit-stimulating environment. Conditions that warrant prescription modification include fatigue and nausea, cytopenias, lymphedema, and bone metastasis. Postcancer exercise is facilitated by instilling a positive attitude toward exercise, confidence in overcoming barriers, and a supportive social environment.