Aerobic Exercise for Breast Cancer Survivors
(ROME Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama at Birmingham
Must not be taking: Steroids, Antibiotics
Disqualifiers: Metastatic cancer, Unstable angina, Schizophrenia, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
This trial studies how exercise and a specific diet can change gut bacteria in breast cancer survivors to help reduce tiredness and improve health.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require that you do not change your usual medications during the study period.
What data supports the effectiveness of the treatment Aerobic Exercise Training for breast cancer survivors?
Is aerobic exercise safe for breast cancer survivors?
Aerobic exercise is generally safe for breast cancer survivors and can provide significant benefits, such as reducing fatigue and improving quality of life. However, exercise programs may need to be adjusted for individuals experiencing specific conditions like fatigue, nausea, or lymphedema (swelling due to lymph fluid).16789
How does aerobic exercise training differ from other treatments for breast cancer survivors?
Aerobic exercise training is unique because it focuses on improving physical fitness and quality of life through regular, moderate-intensity exercise sessions, which can help reduce fatigue, improve mood, and enhance overall well-being. Unlike traditional medical treatments, it emphasizes a holistic approach by incorporating enjoyable activities, social interaction, and skill development, tailored to the individual's needs and limitations.1571011
Eligibility Criteria
This trial is for women aged 18-74 who are breast cancer survivors (stage 0, I, II, or III) and have been free from primary treatment for at least a year. Participants should not be taking probiotics or antibiotics recently, must be able to walk without help, have low exercise capacity, experience fatigue, and get medical clearance.Inclusion Criteria
Physician medical clearance for study participation
English speaking
It's been over a year since I finished my initial breast cancer treatment.
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Exclusion Criteria
I have unstable chest pain.
I am planning to have surgery during the study.
You have dementia or a brain disorder.
See 17 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Exercise Training
Participants undergo 10 weeks of progressive aerobic exercise training supervised by exercise specialists
10 weeks
Regular supervised sessions
Follow-up
Participants are monitored for changes in gut microbiota, fatigue, and other physiological and psychosocial measures
5 weeks
Treatment Details
Interventions
- Aerobic Exercise Training (Behavioural Intervention)
- Attention Control (Behavioural Intervention)
Trial OverviewThe study aims to explore how aerobic exercise affects the gut microbiome in breast cancer survivors and its potential link to reducing fatigue. Participants will either engage in an aerobic exercise program or be part of an attention control group that does not receive this intervention.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Aerobic Exercise TrainingExperimental Treatment1 Intervention
Progressive aerobic exercise training sessions supervised by exercise specialists who have experience training cancer survivors.
Group II: Attention ControlActive Control1 Intervention
The non-aerobic exercise attention control condition will control for the effects of attention with flexibility/toning activities.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Alabama at BirminghamBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
National Cancer Institute (NCI)Collaborator
References
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.
Effects of a short-term differently dosed aerobic exercise on maximum aerobic capacity in breast cancer survivors: a pilot study. [2022]Regular physical activity and exercise improves quality of life and possibly reduces risk of disease relapse and prolongs survival in breast cancer survivors. The aim of this study was to evaluate the impact of a 3-week moderate intensity aerobic training, on aerobic capacity (VO2max) in breast cancer survivors.
Impact of a combined resistance and aerobic exercise program on motivational variables in breast cancer survivors: a randomized controlled trial. [2018]Short term exercise interventions have been shown to be beneficial for breast cancer survivors soon after treatments but longer term adherence is needed.
Exercise parameters in the management of breast cancer: a systematic review of randomized controlled trials. [2022]Previous systematic reviews have examined the efficacy of exercise in improving the quality of life for patients with, and survivors of, breast cancer. This review sets out to determine the parameters of exercise programmes used in randomized controlled trials.
[Aerobic endurance training for cancer patients]. [2019]With the increase in the number of patients who survive cancer, there is a growing need to attend to the physical and emotional effects of cancer and oncological treatment. Reduced physical performance, fatigue, nausea, weight gain, psychological distress, changes in body image, dependency, and reduced quality of life are some of the short- and long-term sequelae of cancer. We describe data from the literature about firstly the effects of aerobic exercise as an additive treatment for cancer patients, and about the feasibility of aerobic exercise secondly during oncological treatment, and thirdly in patients suffering from terminal cancer. The data from the literature support that exercise as an additive treatment may help to attenuate the physical limitations caused by cancer and oncological treatment and there by contribute to rehabilitation and quality of life of cancer patients. Feasibility of aerobic exercise has been demonstrated also for patients suffering from advanced cancer. Aerobic exercise has been shown to provide benefits to cancer patients. It enables these patients to recover their physical function and to return to an active lifestyle. Aerobic exercise seems to be an effective possibility to reduce sequelae of cancer and to increase quality of life.
Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: a phase II randomized trial. [2022]To evaluate the safety and efficacy of moderate-to-high intensity aerobic training in breast cancer patients receiving neoadjuvant chemotherapy.
The Cardiac Rehabilitation Model Improves Fitness, Quality of Life, and Depression in Breast Cancer Survivors. [2019]Exercise is a demonstrated, therapeutic strategy for cancer survivors to minimize many treatment-induced side effects and may decrease risk of recurrence. Nonetheless, structured programs that combine exercise and education are not yet standardized within cancer care. The Health, Exercise, Active Living, Therapeutic lifestyle (HEALTh) program is a clinical exercise program based on the established cardiac rehabilitation model, but customized for female breast cancer survivors. This study assessed the effects of a cardiac rehabilitation program on cardiorespiratory fitness, quality of life, and depressive symptoms in breast cancer survivors.
Exercise in the prevention and rehabilitation of breast cancer. [2021]Breast cancer is the most common type of cancer among women worldwide. Several epidemiological studies have shown an inverse relationship between the risk of breast cancer and physical activity levels, whereas exercise training has been recognized as a significant means in the rehabilitation process of breast cancer survivors. The relative risk reduction of breast cancer for women who engaged in moderate to vigorous physical activity for 3-5 days peek week ranged between 20-40 %. Furthermore, several studies demonstrated a 24-67 % reduction in the risk of total deaths and 50-53 % reduction in the risk of breast cancer deaths in women who are physically active after breast cancer diagnosis compared with sedentary women. Breast cancer survivors should be encouraged to participate in rehabilitation programs in order to obtain numerous physiological and psychological benefits. These include reductions in fatigue and improvements in immune function, physical functioning, body composition, and quality of life. Based on recent scientific evidence, a complete rehabilitation program for patients with breast cancer should combine both strength and aerobic exercise in order to maximize the expected benefits.
Effects of an aerobic exercise programme on fatigue for patients with breast cancer undergoing radiotherapy. [2018]This study was designed to evaluate the efficacy of an aerobic exercise programme on fatigue for Taiwanese breast cancer women under radiotherapy (RT).
Benefits of Aerobic Exercise for Breast Cancer Survivors: A Systematic Review of Randomized Controlled Trials. [2020]Physical exercise may be beneficial to breast cancer (BC) survivors. Here, we systematically summarized the effects of aerobic exercise in BC survivors. We conducted a systematic review of randomized controlled trials (RCTs).
Randomized trial of exercise therapy in women treated for breast cancer. [2022]To examine the effects of aerobic exercise therapy on quality of life (QoL) and associated outcomes in women treated for breast cancer. Evidence suggests that exercise may be beneficial, but no trial has included an exercise-placebo and a usual-care group to control for the attention effects that might be associated with aerobic exercise interventions in cancer patients.