Breast Cancer Clinical Trial
Exercise, Gut Microbiome, and Breast Cancer: Increasing Reach to Underserved Populations
Summary
Understanding the impact exercise has on a cancer survivor's gut microbiome can improve the health and well-being of cancer survivors by enhancing treatments targeting the gut microbiome. Although scientific studies support a link between exercise and the gut microbiome, rigorous randomized trials needed to confirm this causal link are limited and usually involve supervised exercise. Hence, this proposal tests feasibility of a home-based, remote-only research protocol that is more accessible to cancer survivors unable to attend supervised exercise including but not limited to rural populations. This study will also determine if exercise effects on the gut microbiome differ by factors such as race.
Full Description
Forty physically inactive breast cancer survivors will be randomized into 10-week conditions of home-based aerobic exercise training or standard attention control. All participants will receive an energy-balanced, standardized diet. Assessments will occur at baseline and week 10 (post-intervention) by videoconference platform. Feasibility and changes in the gut microbiome will be assessed.
Eligibility Criteria
Inclusion Criteria:
Women
Age 18-70 years
History of breast cancer stage 0, I, II, or III
≥1 year post-primary cancer treatment completion
English speaking
Ambulates without assistance
No antibiotics in past 90 days
Willing to avoid taking probiotics during the study
Has access to a safe place to perform aerobic exercise (e.g., willing to walk in neighborhood or has gym membership or owns relevant exercise equipment at home, etc.)
Weigh < 440 pounds
Exclusion Criteria:
Metastatic or recurrent cancer
Another cancer diagnosis in the past 5 years (not including skin or cervical cancer in situ)
Diabetes
History of bariatric surgery
Unstable angina
New York Heart Association class II, III, or IV congestive heart failure
Uncontrolled asthma
Interstitial lung disease
Current steroid use
Told by a physician to only do exercise prescribed by a physician
Dementia or organic brain syndrome
Schizophrenia or active psychosis
Connective tissue or rheumatologic disease
Participating in >30 minutes of exercise on ≥3 days/week in the past six months
Anticipate elective surgery, medication changes or antibiotics during the study
Contraindication to ≥moderate intensity aerobic exercise
Physical limitations that prevent engaging in ≥moderate intensity aerobic exercise
Breastfeeding, pregnant or anticipate pregnancy during the study
Plan to move residence during the study
Plan to travel for more than 1 week during the study
Anticipate trouble attending the weekly study videoconference calls
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