Clinical trial NCT04088708: Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors
Official title: Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Gut Microbiome
Exercise
Fatigue
Keywords: breast cancer
fatigue
exercise
psychosocial outcomes
inflammation
gut microbiome
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-09-13
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
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: Composition of gut microbiota as measured by fecal samples
timeFrame: 15 weeks after baseline
Secondary outcomes:
measure: Systemic inflammation tested via blood biomarkers
timeFrame: Baseline
measure: Systemic inflammation tested via blood biomarkers
timeFrame: 5 weeks after baseline
measure: Systemic inflammation tested via biomarkers
timeFrame: 10 weeks after baseline
measure: Systemic inflammation tested via blood biomarkers
timeFrame: 15 weeks after baseline
measure: Autonomic nervous system measured through non-invasive ECG
timeFrame: Baseline
measure: Autonomic nervous system measured through non-invasive ECG
timeFrame: 5 weeks after baseline
measure: Autonomic nervous system measured through non-invasive ECG
timeFrame: 10 weeks after baseline
measure: Autonomic nervous system measured through non-invasive ECG
timeFrame: 15 weeks after baseline
measure: Concentration of cortisol measured through hair sample
timeFrame: Baseline
measure: Concentration of cortisol measured through hair sample
timeFrame: 5 weeks after baseline
measure: Concentration of cortisol measured through hair sample
timeFrame: 10 weeks after baseline
measure: Concentration of cortisol measured through hair sample
timeFrame: 15 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: Fatigue measured through fatigue specific questionnaire
timeFrame: 15 weeks after baseline
Other outcomes:
measure: Peak VO2 (oxygen consumption) measured via modified Balke treadmill protocol
timeFrame: Baseline
measure: Peak VO2 (oxygen consumption) measured via modified Balke treadmill protocol
timeFrame: 5 weeks after baseline
measure: Peak VO2 (oxygen consumption) measured via modified Balke treadmill protocol
timeFrame: 10 weeks after baseline
measure: Peak VO2 (oxygen consumption) measured via modified Balke treadmill protocol
timeFrame: 15 weeks after baseline
measure: Walking Economy measured via 6 minute treadmill test
timeFrame: Baseline
measure: Walking Economy measured via 6 minute treadmill test
timeFrame: 5 weeks after baseline
measure: Walking Economy measured via 6 minute treadmill test
timeFrame: 10 weeks after baseline
measure: Walking Economy measured via 6 minute treadmill test
timeFrame: 15 weeks after baseline
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: Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
timeFrame: 15 weeks after baseline
measure: Body composition using a dual energy x-ray absorptiometry
timeFrame: Baseline
measure: Body composition using a dual energy x-ray absorptiometry
timeFrame: 5 weeks after baseline
measure: Body composition using a dual energy x-ray absorptiometry
timeFrame: 10 weeks after baseline
measure: Body composition using a dual energy x-ray absorptiometry
timeFrame: 15 weeks after baseline
measure: FACT-B self-administered survey measuring quality of life
timeFrame: Baseline
measure: FACT-B self-administered survey measuring quality of life
timeFrame: 5 weeks after baseline
measure: FACT-B self-administered survey measuring quality of life
timeFrame: 10 weeks after baseline
measure: FACT-B self-administered survey measuring quality of life
timeFrame: 15 weeks after baseline
measure: Self-efficacy by self-administered survey
timeFrame: Baseline
measure: Self-efficacy by self-administered survey
timeFrame: 6 weeks after baseline
measure: Self-efficacy by self-administered survey
timeFrame: 10 weeks after baseline
measure: Self-efficacy by self-administered survey
timeFrame: 15 weeks after baseline
measure: Self-administered survey measuring mood and stress
timeFrame: Baseline
measure: Self-administered survey measuring mood and stress
timeFrame: 5 weeks after baseline
measure: Self-administered survey measuring mood and stress
timeFrame: 10 weeks after baseline
measure: Self-administered survey measuring mood and stress
timeFrame: 15 weeks after baseline
measure: Self-administered survey measuring memory
timeFrame: Baseline
measure: Self-administered survey measuring memory
timeFrame: 5 weeks after baseline
measure: Self-administered survey measuring memory
timeFrame: 10 weeks after baseline
measure: Self-administered survey measuring memory
timeFrame: 15 weeks after baseline
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Laura Q Rogers, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: