Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors

Not Applicable

Recruiting

• Conditions: Gut Microbiome; Exercise; Fatigue; Breast Cancer
• Interventions: Other: Aerobic Exercise Training; Other: Attention Control

• Registration Number: NCT04088708
• Lead Sponsor: University of Alabama at Birmingham

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 fatigue.

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.

Study Timeline

• Study First Submitted: 2019-08-03
• Study First Submitted QC: 2019-09-10
• Study First Posted: 2019-09-13
• Study Start: 2020-01-17
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 126

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobic Exercise Training	Aerobic Exercise Training	Progressive aerobic exercise training sessions supervised by exercise specialists who have experience training cancer survivors.
Attention Control	Attention Control	The non-aerobic exercise attention control condition will control for the effects of attention with flexibility/toning activities.

Primary Outcome Measures

Name	Time	Method
Composition of gut microbiota as measured by fecal samples	15 weeks after baseline	Using standard diversity and taxa comparison metrics

Secondary Outcome Measures

Name	Time	Method
Autonomic nervous system measured through non-invasive ECG	15 weeks after baseline	Using a Actiheart 5 to measure heart rate variability and impedance cardiography while resting quietly
Systemic inflammation tested via biomarkers	10 weeks after baseline	Blood samples will be analyzed for markers of inflammation (IL-6, IL-10)
Systemic inflammation tested via blood biomarkers	15 weeks after baseline	Blood samples will be analyzed for markers of inflammation (IL-6, IL-10)
Concentration of cortisol measured through hair sample	15 weeks after baseline	Hormone change that is associated with stress
Fatigue measured through fatigue specific questionnaire	15 weeks after baseline	Fatigue Symptom Inventory which contains 13 items (fatigue intensity = mean of 4 items, 1 to 10 scale; fatigue interference = mean of 7 items, 0 to 10 scale; 2 general fatigue items = 0 to 7 scale and 1 to 10 scale); higher score indicates greater fatigue

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States