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Exercise Therapy for Breast Cancer

N/A
Recruiting
Led By Jessica Scott, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Exercise intolerance (i.e., patients must have a VO2peak below the predicted for active age and sex-matched individuals. (+/- the technical error of 1.32 mL/kg/min). Note: Normative values are available up to 80 years of age)
Female
Must not have
Any of the following absolute contraindications to cardiopulmonary exercise testing: Acute myocardial infarction within 3-5 days of any planned study procedures, Unstable angina, Uncontrolled arrhythmia causing symptoms or hemodynamic compromise, Recurrent syncope, Active endocarditis, Acute myocarditis or pericarditis, Symptomatic severe aortic stenosis, Uncontrolled heart failure, Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures, Thrombosis of lower extremities, Suspected dissecting aneurysm, Uncontrolled asthma, Pulmonary edema, Respiratory failure, Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (e.g., infection, renal failure, thyrotoxicosis), Presence of any other concurrent, actively treated malignancy, History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer), Presence of distant metastatic disease (i.e., stage IV), Room air desaturation at rest ≤ 85%, Mental impairment leading to inability to cooperate, Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 32 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of different amounts of aerobic exercise on cardiorespiratory fitness.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Aerobic exercise is generally safe but can include muscle soreness, fatigue, joint pain or discomfort during activity. Rarely, it may trigger underlying heart conditions in susceptible individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My exercise capacity is lower than expected for my age and sex.
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I am female.
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I am between 21 and 80 years old.
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I had surgery for early stage (I-III) breast cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I don't have any major heart, lung, recent cancer, or other health issues that would make exercise testing unsafe for me.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~32 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 32 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
peak oxygen consumption (VO2peak; ml O2.kg-1.min) response rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,111,928 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,979 Previous Clinical Trials
599,686 Total Patients Enrolled
Jessica Scott, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
688 Total Patients Enrolled

Media Library

Aerobic Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT04458532 — N/A
~16 spots leftby Jul 2025
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