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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 74 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized controlled trial
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)
Masking Description
Assessors will be blinded to participant study group allocation

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Aerobic Exercise Training 		Progressive aerobic exercise training sessions supervised by exercise specialists who have experience training cancer survivors.
  • Other: Aerobic Exercise Training
    Each session will last 20 to 60 minutes depending on the stage of progression (shorter duration in the first few weeks). Sessions will occur on nonconsecutive days of the week. Moderate-intensity, continuous aerobic exercise will be used to target large muscle groups (e.g., legs) with the principal goal of increasing cardiorespiratory fitness. Exercise intensity will be gradually increased. To mitigate stagnation and support continued improvement of cardiorespiratory fitness, high-intensity interval exercise will be added in later weeks of the intervention.
Active Comparator
Attention Control 		The non-aerobic exercise attention control condition will control for the effects of attention with flexibility/toning activities.
  • Other: Attention Control
    The flexibility/toning control condition will be delivered using the same frequency as the aerobic condition (i.e., 3 times per week) and use light resistance bands of least difficulty. The flexibility/toning sessions will last about 40 minutes, be led by trained exercise specialists. Flexibility/toning activities will target the head/neck, shoulder, elbow/forearm, hand/wrist, trunk/hip, and ankle/foot. The progression of activities over the 10-week period will involve performing additional exercises and sets along with using progressively thicker elastic resistance bands (i.e., Thera-bands) that provide minimal resistance.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294-001
Contact:
Laura Q Rogers, MD, MPH
(205) 934-9735
rogersl@uab.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Laura Q Rogers, MD, MPH
(205) - 934 - 9735
rogersl@uab.edu

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. 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.