Trial Summary
What is the purpose of this trial?This study will compare the effects on cardiorespiratory fitness (CRF) of aerobic exercise in different amounts (number of minutes/session) over different periods of time (number of weeks). Aerobic exercise is physical activity of light-to-moderate intensity that uses the large muscle groups (muscles in your legs, buttocks, back, and chest) and can be performed for at least 10 minutes.
The researchers will study the effects of different exercise programs on how well the study participants' bodies use oxygen, how well their heart pumps blood, how well their lungs function, and how healthy their blood vessels are.
Is aerobic training a promising treatment for breast cancer?Yes, aerobic training is a promising treatment for breast cancer. It can improve upper limb function, heart and lung health, and overall quality of life for breast cancer patients. It helps patients recover physically and return to an active lifestyle, reducing the negative effects of cancer and its treatment.12567
What safety data exists for exercise therapy in breast cancer treatment?Several studies have evaluated the safety of aerobic exercise in breast cancer patients. A systematic review and meta-analysis explored its feasibility in mitigating cardiotoxicity from breast cancer therapy. A randomized controlled trial assessed the feasibility and safety of aerobic training in metastatic breast cancer patients, while another phase II trial evaluated its safety and efficacy in operable breast cancer patients receiving neoadjuvant chemotherapy. Overall, these studies suggest that aerobic exercise is a feasible and safe adjunct therapy for breast cancer patients, helping to mitigate treatment side effects and improve quality of life.13458
What data supports the idea that Exercise Therapy for Breast Cancer is an effective treatment?The available research shows that Exercise Therapy, specifically aerobic exercise, is effective for breast cancer patients. It helps improve upper limb function, heart and lung health, and overall quality of life after breast cancer surgery. Studies also indicate that aerobic exercise can reduce the negative side effects of chemotherapy and support recovery. Compared to other treatments, aerobic exercise is a safe and beneficial option for improving physical function and promoting rehabilitation in breast cancer patients.12356
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial investigators for more details.
Eligibility Criteria
This trial is for post-menopausal women aged 21-80 who have completed treatment for early stage (I-III) breast cancer within the last 1-5 years. Participants should be able to perform a baseline exercise test without high-risk heart issues and must have lower than expected fitness levels for their age.Inclusion Criteria
My exercise capacity is lower than expected for my age and sex.
I am female.
I am between 21 and 80 years old.
I had surgery for early stage (I-III) breast cancer.
Exclusion Criteria
I don't have any major heart, lung, recent cancer, or other health issues that would make exercise testing unsafe for me.
Treatment Details
The study tests how different amounts and durations of aerobic exercise affect cardiovascular health in participants. It measures oxygen use, heart function, lung capacity, and blood vessel health through various exercise programs.
4Treatment groups
Experimental Treatment
Active Control
Group I: (C) breast cancer after completion of chemoExperimental Treatment1 Intervention
300 min/wk for 32 weeks.
Group II: (B) breast cancer after completion of chemoExperimental Treatment1 Intervention
150 min/wk for 32 weeks.
Group III: (A) breast cancer after completion of chemoExperimental Treatment1 Intervention
300 min/wk for 16 weeks, followed by 16 weeks of usual care.
Group IV: (D) breast cancer after completion of chemoActive Control1 Intervention
150 min/wk for 16 weeks, followed by 16 weeks of usual care.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Hartford Healthcare Cancer Institute @ Hartford Hospital (Data Collection Only)Hartford, CT
Memorial Sloan Kettering Cancer CenterNew York, NY
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
[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.
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.
Modulation of circulating angiogenic factors and tumor biology by aerobic training in breast cancer patients receiving neoadjuvant chemotherapy. [2021]Aerobic exercise training (AET) is an effective adjunct therapy to attenuate the adverse side-effects of adjuvant chemotherapy in women with early breast cancer. Whether AET interacts with the antitumor efficacy of chemotherapy has received scant attention. We carried out a pilot study to explore the effects of AET in combination with neoadjuvant doxorubicin-cyclophosphamide (AC+AET), relative to AC alone, on: (i) host physiology [exercise capacity (VO2 peak), brachial artery flow-mediated dilation (BA-FMD)], (ii) host-related circulating factors [circulating endothelial progenitor cells (CEP) cytokines and angiogenic factors (CAF)], and (iii) tumor phenotype [tumor blood flow ((15)O-water PET), tissue markers (hypoxia and proliferation), and gene expression] in 20 women with operable breast cancer. AET consisted of three supervised cycle ergometry sessions/week at 60% to 100% of VO2 peak, 30 to 45 min/session, for 12 weeks. There was significant time × group interactions for VO2 peak and BA-FMD, favoring the AC+AET group (P 0.05). Whole-genome microarray tumor analysis revealed significant differential modulation of 57 pathways (P
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.
Feasibility, safety, and efficacy of aerobic training in pretreated patients with metastatic breast cancer: A randomized controlled trial. [2023]The investigation of exercise training in metastatic breast cancer has received minimal attention. This study determined the feasibility and safety of aerobic training in metastatic breast cancer.
Effectiveness of aerobic exercise on upper limb function following breast cancer treatment: a systematic review and meta-analysis. [2021]Aerobic exercise is currently considered to be an effective method of rehabilitation in breast cancer patients. Studies have shown that aerobic exercise after breast cancer surgery can improve upper limb function, cardiopulmonary function, and quality of life. Breast cancer rehabilitation guidelines encourage patients to actively participate in aerobic exercise to promote rehabilitation, the current study is to evaluate the effectiveness of aerobic exercise on upper limb muscle strength and range of motion (ROM) following breast cancer treatment.
Impact of community-based exercise program participation on aerobic capacity in women with and without breast cancer. [2021]Evidence for exercise as an efficacious strategy to improve aerobic capacity of breast cancer survivors (BCS) has come largely from intervention studies conducted in laboratory settings. There is an increasing need to translate to community-type settings, but the efficacy of those interventions using gold standard evaluation is not well-established.
Feasibility of Aerobic Exercise Training to Mitigate Cardiotoxicity of Breast Cancer Therapy: A Systematic Review and Meta-Analysis. [2023]Current anticancer treatments for breast cancer (BC) may cause cardiotoxicity. This study aimed to investigate the effectiveness of aerobic exercise in mitigating cardiotoxicity caused by BC therapy.