Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04088708

Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Exercise Fatigue Gut Microbiome Inflammation Motor Activity Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294-001, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic exercise training

Other

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.

Attention Control

Other

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.

Primary outcomes

  1. Composition of gut microbiota as measured by fecal samples

    Time frame: Baseline

    Using standard diversity and taxa comparison metrics

  2. Composition of gut microbiota as measured by fecal samples

    Time frame: 5 weeks after baseline

    Using standard diversity and taxa comparison metrics

  3. Composition of gut microbiota as measured by fecal samples

    Time frame: 10 weeks after baseline

    Using standard diversity and taxa comparison metrics

  4. Composition of gut microbiota as measured by fecal samples

    Time frame: 15 weeks after baseline

    Using standard diversity and taxa comparison metrics

Secondary outcomes

  1. Systemic inflammation tested via blood biomarkers

    Time frame: Baseline

    Blood samples will be analyzed for markers of inflammation (IL-6, IL-10)

  2. Systemic inflammation tested via blood biomarkers

    Time frame: 5 weeks after baseline

    Blood samples will be analyzed for markers of inflammation (IL-6, IL-10)

  3. Systemic inflammation tested via biomarkers

    Time frame: 10 weeks after baseline

    Blood samples will be analyzed for markers of inflammation (IL-6, IL-10)

  4. Systemic inflammation tested via blood biomarkers

    Time frame: 15 weeks after baseline

    Blood samples will be analyzed for markers of inflammation (IL-6, IL-10)

  5. Autonomic nervous system measured through non-invasive ECG

    Time frame: Baseline

    Using a Actiheart 5 to measure heart rate variability and impedance cardiography while resting quietly

  6. Autonomic nervous system measured through non-invasive ECG

    Time frame: 5 weeks after baseline

    Using a Actiheart 5 to measure heart rate variability and impedance cardiography while resting quietly

  7. Autonomic nervous system measured through non-invasive ECG

    Time frame: 10 weeks after baseline

    Using a Actiheart 5 to measure heart rate variability and impedance cardiography while resting quietly

  8. Autonomic nervous system measured through non-invasive ECG

    Time frame: 15 weeks after baseline

    Using a Actiheart 5 to measure heart rate variability and impedance cardiography while resting quietly

  9. Concentration of cortisol measured through hair sample

    Time frame: Baseline

    Hormone change that is associated with stress

  10. Concentration of cortisol measured through hair sample

    Time frame: 5 weeks after baseline

    Hormone change that is associated with stress

  11. Concentration of cortisol measured through hair sample

    Time frame: 10 weeks after baseline

    Hormone change that is associated with stress

  12. Concentration of cortisol measured through hair sample

    Time frame: 15 weeks after baseline

    Hormone change that is associated with stress

  13. Fatigue measured through fatigue specific questionnaire

    Time frame: 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

  14. Fatigue measured through fatigue specific questionnaire

    Time frame: 5 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

  15. Fatigue measured through fatigue specific questionnaire

    Time frame: 10 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

  16. Fatigue measured through fatigue specific questionnaire

    Time frame: 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

Other outcomes

  1. Peak VO2 (oxygen consumption) measured via modified Balke treadmill protocol

    Time frame: Baseline

    Cardiorespiratory fitness test on a treadmill

  2. Peak VO2 (oxygen consumption) measured via modified Balke treadmill protocol

    Time frame: 5 weeks after baseline

    Cardiorespiratory fitness test on a treadmill

  3. Peak VO2 (oxygen consumption) measured via modified Balke treadmill protocol

    Time frame: 10 weeks after baseline

    Cardiorespiratory fitness test on a treadmill

  4. Peak VO2 (oxygen consumption) measured via modified Balke treadmill protocol

    Time frame: 15 weeks after baseline

    Cardiorespiratory fitness test on a treadmill

  5. Walking Economy measured via 6 minute treadmill test

    Time frame: Baseline

    Fitness test on a treadmill

  6. Walking Economy measured via 6 minute treadmill test

    Time frame: 5 weeks after baseline

    Fitness test on a treadmill

  7. Walking Economy measured via 6 minute treadmill test

    Time frame: 10 weeks after baseline

    Fitness test on a treadmill

  8. Walking Economy measured via 6 minute treadmill test

    Time frame: 15 weeks after baseline

    Fitness test on a treadmill

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

    Time frame: Baseline

    Motion sensor measures physical activity not observed during intervention activities

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

    Time frame: 5 weeks after baseline

    Motion sensor measures physical activity not observed during intervention activities

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

    Time frame: 10 weeks after baseline

    Motion sensor measures physical activity not observed during intervention activities

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

    Time frame: 15 weeks after baseline

    Motion sensor measures physical activity not observed during intervention activities

  13. Body composition using a dual energy x-ray absorptiometry

    Time frame: Baseline

    Measurement of body composition

  14. Body composition using a dual energy x-ray absorptiometry

    Time frame: 5 weeks after baseline

    Measurement of body composition

  15. Body composition using a dual energy x-ray absorptiometry

    Time frame: 10 weeks after baseline

    Measurement of body composition

  16. Body composition using a dual energy x-ray absorptiometry

    Time frame: 15 weeks after baseline

    Measurement of body composition

  17. FACT-B self-administered survey measuring quality of life

    Time frame: Baseline

    Functional Assessment of Cancer Therapy (FACT) - Breast quality of life scale (37 items; 0 to 4 scale; range is 0 to 148); higher score indicates better quality of life

  18. FACT-B self-administered survey measuring quality of life

    Time frame: 5 weeks after baseline

    Functional Assessment of Cancer Therapy (FACT) - Breast quality of life scale (37 items; 0 to 4 scale; range is 0 to 148); higher score indicates better quality of life

  19. FACT-B self-administered survey measuring quality of life

    Time frame: 10 weeks after baseline

    Functional Assessment of Cancer Therapy (FACT) - Breast quality of life scale (37 items; 0 to 4 scale; range is 0 to 148); higher score indicates better quality of life

  20. FACT-B self-administered survey measuring quality of life

    Time frame: 15 weeks after baseline

    Functional Assessment of Cancer Therapy (FACT) - Breast quality of life scale (37 items; 0 to 4 scale; range is 0 to 148); higher score indicates better quality of life

  21. Self-efficacy by self-administered survey

    Time frame: Baseline

    Self-efficacy measured with 15 items (barriers self-efficacy = 9 items and walking self-efficacy = 6 items, mean of 0% to 100% Scale, range is 0% to 100%); higher score indicates higher self-efficacy.

  22. Self-efficacy by self-administered survey

    Time frame: 6 weeks after baseline

    Self-efficacy measured with 15 items (barriers self-efficacy = 9 items and walking self-efficacy = 6 items, mean of 0% to 100% Scale, range is 0% to 100%); higher score indicates higher self-efficacy.

  23. Self-efficacy by self-administered survey

    Time frame: 10 weeks after baseline

    Self-efficacy measured with 15 items (barriers self-efficacy = 9 items and walking self-efficacy = 6 items, mean of 0% to 100% Scale, range is 0% to 100%); higher score indicates higher self-efficacy.

  24. Self-efficacy by self-administered survey

    Time frame: 15 weeks after baseline

    Self-efficacy measured with 15 items (barriers self-efficacy = 9 items and walking self-efficacy = 6 items, mean of 0% to 100% Scale, range is 0% to 100%); higher score indicates higher self-efficacy.

  25. Self-administered survey measuring mood and stress

    Time frame: Baseline

    Measurement of mood and stress after a traumatic experience, Civilian PTSD ( total of 17 items, 1 to 5 scale; range of 17 to 85) higher scores indicate greater PTSD. Perceived Stress Scale - 10 (10 items, 1 to 5 scale; 10 to 50 range) higher score indicates greater perceived stress.

  26. Self-administered survey measuring mood and stress

    Time frame: 5 weeks after baseline

    Measurement of mood and stress after a traumatic experience, Civilian PTSD ( total of 17 items, 1 to 5 scale; range of 17 to 85) higher scores indicate greater PTSD. Perceived Stress Scale - 10 (10 items, 1 to 5 scale; 10 to 50 range) higher score indicates greater perceived stress.

  27. Self-administered survey measuring mood and stress

    Time frame: 10 weeks after baseline

    Measurement of mood and stress after a traumatic experience, Civilian PTSD ( total of 17 items, 1 to 5 scale; range of 17 to 85) higher scores indicate greater PTSD. Perceived Stress Scale - 10 (10 items, 1 to 5 scale; 10 to 50 range) higher score indicates greater perceived stress.

  28. Self-administered survey measuring mood and stress

    Time frame: 15 weeks after baseline

    Measurement of mood and stress after a traumatic experience, Civilian PTSD ( total of 17 items, 1 to 5 scale; range of 17 to 85) higher scores indicate greater PTSD. Perceived Stress Scale - 10 (10 items, 1 to 5 scale; 10 to 50 range) higher score indicates greater perceived stress.

  29. Self-administered survey measuring memory

    Time frame: Baseline

    Measurement of memory through frequency of forgetting scale (total of 10 items, 1 to 7 scale; range of 10 to 70) higher score indicate lower frequency of forgetting and higher level of memory.

  30. Self-administered survey measuring memory

    Time frame: 5 weeks after baseline

    Measurement of memory through frequency of forgetting scale (total of 10 items, 1 to 7 scale; range of 10 to 70) higher score indicate lower frequency of forgetting and higher level of memory.

  31. Self-administered survey measuring memory

    Time frame: 10 weeks after baseline

    Measurement of memory through frequency of forgetting scale (total of 10 items, 1 to 7 scale; range of 10 to 70) higher score indicate lower frequency of forgetting and higher level of memory.

  32. Self-administered survey measuring memory

    Time frame: 15 weeks after baseline

    Measurement of memory through frequency of forgetting scale (total of 10 items, 1 to 7 scale; range of 10 to 70) higher score indicate lower frequency of forgetting and higher level of memory.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME Study)

Acronym: ROME

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Sep 13, 2019
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.