Status:
ACTIVE_NOT_RECRUITING
Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Gut Microbiome
Eligibility:
FEMALE
18-74 years
Phase:
NA
Brief Summary
The primary goal of this project is to determine the effects of exercise on the gut microbiome in breast cancer survivors and determine how these changes may relate to psychosocial symptoms such as fa...
Detailed Description
Cancer survivors are at increased risk of gut bacteria communities that can negatively impact health and energy level and it is possible that exercise can cause healthy changes in these communities. T...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Women ages 18 to 74 years with a history of breast cancer stage 0, I, II, or III,
- ≥ 1-year post-completion of primary treatment for breast cancer (chemotherapy and/or radiation),
- Average fatigue over the past week rated as ≥3 on a 1 to 10 Likert scale, cut point chosen because it is a clinically meaningful cutpoint,93
- English speaking,
- Physician medical clearance for study participation,
- Able to ambulate without assistance,
- No antibiotics for the past 90 days,
- Willing to avoid taking probiotics for the duration of the study
- Peak VO2 \<30 ml/kg/min (note: will measure peak VO2 if the participant meets all other criteria and consents to lab-based screening).
- Exclusion criteria:
- Metastatic or recurrent cancer
- Another diagnosis of cancer in the past 5 years (not including skin or cervical cancer in situ), 3)
- Unstable angina
- New York Heart Association class II, III, or IV congestive heart failure
- Uncontrolled asthma
- Interstitial lung disease
- Current steroid use
- Having been 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 (i.e., systemic lupus erythematosus, rheumatoid arthritis, amyloidosis, Reiter's syndrome, psoriatic arthritis, mixed connective tissue disease, Sjögren's syndrome, CREST syndrome, polymyositis, dermatomyositis, progressive systemic sclerosis, vasculitis, polymyalgia rheumatic, temporal arteritis)
- Anticipate elective surgery during the study period
- Anticipate changes in usual medications during the study period
- Plan to move residence out of the local area during the study period
- Plan to travel out of the local area for \>1 week during study participation
- Contraindication to engaging in moderate-to-vigorous intensity aerobic exercise
- Currently pregnant or anticipate pregnancy during study participation
- Live or work \>50 miles from study site or do not have transportation to study site
- BMI \>50
- Anticipate needing antibiotics during the study period
Exclusion
Key Trial Info
Start Date :
January 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT04088708
Start Date
January 17 2020
End Date
August 31 2026
Last Update
September 16 2025
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-001