Clinical trial NCT05000502: Exercise, Gut Microbiome, and Breast Cancer: Increasing Reach to Underserved Populations
Official title: Exercise, Gut Microbiome, and Breast Cancer: Increasing Reach to Underserved Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Breast Cancer
Keywords: Exercise
Gut Microbiome
Breast Cancer
Cancer
Aerobic Exercise
Microbiome
Female Breast Cancer
Flexibility Exercise
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed description: Forty physically inactive breast cancer survivors will be randomized into 10-week conditions of home-based aerobic exercise training or standard attention control. All participants will be asked to maintain their pre-study diet and attempt to maintain their body weight while participating in the study. Assessments will occur at baseline, week 5 (mid-intervention), and week 10 (post-intervention) by videoconference platform. Study feasibility and changes in the gut microbiome will be assessed.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* Breastfeeding, pregnant or anticipate pregnancy during the study
* Plan to move residence during the study
* Plan to travel for more than 1 week during the study
* Anticipate trouble attending the weekly study videoconference calls
* History of bariatric surgery
* Body weight greater than 440 lbs
* Any social, psychological, or physical condition that interferes with the participant's ability to complete study activities or unduly increases study risk

Primary outcomes:
measure: Feasibility - Recruitment
timeFrame: Baseline
measure: Feasibility - Adherence to study protocol activities
timeFrame: Throughout 10 week study period
measure: Feasibility - Attrition rates
timeFrame: Throughout 10 week study period
measure: Feasibility - Adverse events
timeFrame: Throughout 10 week study period
measure: Feasibility - Participant satisfaction
timeFrame: At conclusion of 10 week study period
Secondary outcomes:
measure: Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
timeFrame: Baseline
measure: Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
timeFrame: 5 weeks after baseline
measure: Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
timeFrame: 10 weeks after baseline
measure: Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale
timeFrame: Baseline
measure: Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale
timeFrame: 5 weeks after baseline
measure: Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale
timeFrame: 10 weeks after baseline
measure: Muscle mass analysis using a Tanita bioelectrical impedance analysis scale
timeFrame: Baseline
measure: Muscle mass analysis using a Tanita bioelectrical impedance analysis scale
timeFrame: 5 weeks after baseline
measure: Muscle mass analysis using a Tanita bioelectrical impedance analysis scale
timeFrame: 10 weeks after baseline
measure: Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale
timeFrame: Baseline
measure: Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale
timeFrame: 5 weeks after baseline
measure: Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale
timeFrame: 10 weeks after baseline
measure: Change in physical performance
timeFrame: Baseline
measure: Change in physical performance
timeFrame: 5 weeks after baseline
measure: Change in physical performance
timeFrame: 10 weeks after baseline
measure: Composition of gut microbiota as measured by fecal samples
timeFrame: Baseline
measure: Composition of gut microbiota as measured by fecal samples
timeFrame: 5 weeks after baseline
measure: Composition of gut microbiota as measured by fecal samples
timeFrame: 10 weeks after baseline
measure: Fatigue measured through fatigue specific questionnaire
timeFrame: Baseline
measure: Fatigue measured through fatigue specific questionnaire
timeFrame: 5 weeks after baseline
measure: Fatigue measured through fatigue specific questionnaire
timeFrame: 10 weeks after baseline
measure: Depression and Anxiety measured through specific questionnaire
timeFrame: Baseline
measure: Depression and Anxiety measured through specific questionnaire
timeFrame: 5 weeks after baseline
measure: Depression and Anxiety measured through specific questionnaire
timeFrame: 10 weeks after baseline
measure: Sleep dysfunction measured through specific questionnaire
timeFrame: Baseline
measure: Sleep dysfunction measured through specific questionnaire
timeFrame: 5 weeks after baseline
measure: Sleep dysfunction measured through specific questionnaire
timeFrame: 10 weeks after baseline
measure: Pain measured through Patient Reported Outcomes Measurement Information System [PROMIS®]
timeFrame: Baseline
measure: Pain measured through Patient Reported Outcomes Measurement Information System [PROMIS®]
timeFrame: 5 weeks after baseline
measure: Pain measured through Patient Reported Outcomes Measurement Information System [PROMIS®]
timeFrame: 10 weeks after baseline
measure: Post-traumatic stress measured through specific questionnaire
timeFrame: Baseline
measure: Post-traumatic stress measured through specific questionnaire
timeFrame: 5 weeks after baseline
measure: Post-traumatic stress measured through specific questionnaire
timeFrame: 10 weeks after baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Laura Rogers, MD
role: PRINCIPAL_INVESTIGATOR
References: