Exercise, Gut Microbiome, and Breast Cancer: Increasing Reach to Underserved Populations

NCT05000502 | Completed

• 2 other identifiers: 300007016BCRFA
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Female Breast Cancer

Keywords

Exercise; Gut Microbiome; Breast Cancer; Cancer; Aerobic Exercise; Microbiome; Female Breast Cancer; Flexibility Exercise

Outcome Measures

Primary Outcomes (5)

• Feasibility - Recruitment

  Number of participants excluded or not agreeing to participate will be measured

  Baseline

• Feasibility - Adherence to study protocol activities

  Feasibility measure (e.g. percent of assessments and intervention sessions completed

  Throughout 10 week study period

• Feasibility - Attrition rates

  Feasibility measure of the number of participants who dropout or are withdrawn

  Throughout 10 week study period

• Feasibility - Adverse events

  Feasibility measure of the number of adverse events recorded by staff during the study period

  Throughout 10 week study period

• Feasibility - Participant satisfaction

  Self-Administered survey given to the participant at the conclusion of the 10 week study period

  At conclusion of 10 week study period

Secondary Outcomes (33)

• Accelerometer Measured Free-living physical activity (e.g., minutes of activity)

  Baseline

• Accelerometer Measured Free-living physical activity (e.g., minutes of activity)

  5 weeks after baseline

• Accelerometer Measured Free-living physical activity (e.g., minutes of activity)

  10 weeks after baseline

• Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale

  Baseline

• Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale

  5 weeks after baseline

Study Arms (2)

Home-based aerobic exercise training

EXPERIMENTAL

home-based aerobic exercise condition will receive a fitness bracelet (with heart rate measurement capability) and weekly exercise counseling from an exercise trainer (i.e., exercise physiologist) by videoconference. The weekly counseling will be guided by the fitness bracelet data (both participant and exercise trainer will share the same log in information). The aerobic exercise progression will gradually increase duration and intensity of aerobic exercise with the goal of improving cardiorespiratory fitness.

Behavioral: Home-based exercise intervention

Home-based standard attention flexibility/toning control

ACTIVE COMPARATOR

Home-based standard attention flexibility/toning control will receive light resistance bands, stretching/toning log book, and weekly videoconference counseling from an exercise trainer.

Behavioral: Home-based exercise intervention

Interventions

Home-based exercise intervention BEHAVIORAL

A 10-week home-based exercise intervention including weekly video conferences with exercise specialists.

Home-based aerobic exercise training; Home-based standard attention flexibility/toning control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-Hispanic white or black 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.)
• Has access to good internet and WIFI and device capable of videoconferencing (the study has limited resources to loan tablets and hotspots)

You may not qualify if:

• Metastatic or recurrent cancer
• Another cancer diagnosis in the past 5 years (not including skin or cervical cancer in situ)
• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Motor Activity; Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Behavior; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Laura Rogers, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Staff doing assessments will be masked to study group allocation
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Med - Preventive Medicine

Model Details: 40 breast cancer survivors will be randomized (like flipping a coin) to one of two study conditions: 1) home-based aerobic exercise training (with aerobic exercise progression targeting improved cardiorespiratory fitness) or 2) standard attention control (stretching exercises). All participants will be asked to maintain their usual diet and avoid change in body weight during the study.

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 11, 2021
• Study Start: September 1, 2021
• Primary Completion: January 22, 2024
• Study Completion: January 31, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)