Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors (ROME)

The University of Alabama at Birmingham

Status: Active, not recruiting

Conditions: Breast Cancer; Gut Microbiome; Fatigue; Exercise

Treatments: Other: Attention Control; Other: Aerobic Exercise Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04088708

R01CA235598 (U.S. NIH Grant/Contract)

IRB-30000320

Details and patient eligibility

About

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 fatigue.

Full 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. Through careful design, this study will use a controlled-feeding diet and 10 weeks of exercise training to determine exercise effects on the number, distribution, and types of bacteria in the gut of breast cancer survivors. These changes will then be linked to fatigue and physiologic effects of exercise to determine how the information can be used to enhance exercise benefits and identify new treatment strategies leveraging changes in gut bacteria communities.

Enrollment: 126 estimated patients

Sex: Female

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 2 patient groups

Aerobic Exercise Training

Experimental group

Description:

Progressive aerobic exercise training sessions supervised by exercise specialists who have experience training cancer survivors.

Treatment:

Other: Aerobic Exercise Training

Attention Control

Active Comparator group

Description:

The non-aerobic exercise attention control condition will control for the effects of attention with flexibility/toning activities.

Treatment:

Other: Attention Control