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Completed

NCT Number: NCT05000502

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

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.

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Key information

Conditions

Female Breast Cancer Behavior Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Home-based exercise intervention

Behavioral

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

Primary outcomes

  1. Feasibility - Recruitment

    Time frame: Baseline

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

  2. Feasibility - Adherence to study protocol activities

    Time frame: Throughout 10 week study period

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

  3. Feasibility - Attrition rates

    Time frame: Throughout 10 week study period

    Feasibility measure of the number of participants who dropout or are withdrawn

  4. Feasibility - Adverse events

    Time frame: Throughout 10 week study period

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

  5. Feasibility - Participant satisfaction

    Time frame: At conclusion of 10 week study period

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

Secondary outcomes

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

    Time frame: Baseline

    Motion sensor measures physical activity not observed during intervention activities

  2. 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

  3. 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

  4. Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale

    Time frame: Baseline

    Measurement of body fat percentage (0-100%) where a lower percentage is better.

  5. Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale

    Time frame: 5 weeks after baseline

    Measurement of body fat percentage (0-100%) where a lower percentage is better.

  6. Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale

    Time frame: 10 weeks after baseline

    Measurement of body fat percentage (0-100%) where a lower percentage is better.

  7. Muscle mass analysis using a Tanita bioelectrical impedance analysis scale

    Time frame: Baseline

    Measurement of muscle mass (0 - max body weight in kilograms) where having more muscle mass can be considered positive.

  8. Muscle mass analysis using a Tanita bioelectrical impedance analysis scale

    Time frame: 5 weeks after baseline

    Measurement of muscle mass (0 - max body weight in kilograms) where having more muscle mass can be considered positive.

  9. Muscle mass analysis using a Tanita bioelectrical impedance analysis scale

    Time frame: 10 weeks after baseline

    Measurement of muscle mass (0 - max body weight in kilograms) where having more muscle mass can be considered positive.

  10. Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale

    Time frame: Baseline

    Measurement of height (m) and weight (kg) to assess body mass index, where a higher body mass index is worse.

  11. Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale

    Time frame: 5 weeks after baseline

    Measurement of height (m) and weight (kg) to assess body mass index, where a higher body mass index is worse.

  12. Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale

    Time frame: 10 weeks after baseline

    Measurement of height (m) and weight (kg) to assess body mass index, where a higher body mass index is worse.

  13. Change in physical performance

    Time frame: Baseline

    Participants will complete a 2-minute step test measured by study staff through videoconference

  14. Change in physical performance

    Time frame: 5 weeks after baseline

    Participants will complete a 2-minute step test measured by study staff through videoconference

  15. Change in physical performance

    Time frame: 10 weeks after baseline

    Participants will complete a 2-minute step test measured by study staff through videoconference

  16. Composition of gut microbiota as measured by fecal samples

    Time frame: Baseline

    Using standard diversity and taxa comparison metrics

  17. Composition of gut microbiota as measured by fecal samples

    Time frame: 5 weeks after baseline

    Using standard diversity and taxa comparison metrics

  18. Composition of gut microbiota as measured by fecal samples

    Time frame: 10 weeks after baseline

    Using standard diversity and taxa comparison metrics

  19. 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

  20. 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

  21. 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

  22. Depression and Anxiety measured through specific questionnaire

    Time frame: Baseline

    Hospital Anxiety and Depression Scale [HADS] which contains 14 items (depression = total of 7 items, 0 to 3 scale; anxiety = total of 7 items, 0 to 3 scale) higher scores indicate greater depression and/or anxiety

  23. Depression and Anxiety measured through specific questionnaire

    Time frame: 5 weeks after baseline

    Hospital Anxiety and Depression Scale [HADS] which contains 14 items (depression = total of 7 items, 0 to 3 scale; anxiety = total of 7 items, 0 to 3 scale) higher scores indicate greater depression and/or anxiety

  24. Depression and Anxiety measured through specific questionnaire

    Time frame: 10 weeks after baseline

    Hospital Anxiety and Depression Scale [HADS] which contains 14 items (depression = total of 7 items, 0 to 3 scale; anxiety = total of 7 items, 0 to 3 scale) higher scores indicate greater depression and/or anxiety

  25. Sleep dysfunction measured through specific questionnaire

    Time frame: Baseline

    Pittsburgh Sleep Quality Index which contains 7 components (sleep dysfunction = total of 7 components, 0 to 3 scale) higher score indicates worse sleep quality

  26. Sleep dysfunction measured through specific questionnaire

    Time frame: 5 weeks after baseline

    Pittsburgh Sleep Quality Index which contains 7 components (sleep dysfunction = total of 7 components, 0 to 3 scale) higher score indicates worse sleep quality

  27. Sleep dysfunction measured through specific questionnaire

    Time frame: 10 weeks after baseline

    Pittsburgh Sleep Quality Index which contains 7 components (sleep dysfunction = total of 7 components, 0 to 3 scale) higher score indicates worse sleep quality

  28. Pain measured through Patient Reported Outcomes Measurement Information System [PROMIS®]

    Time frame: Baseline

    PROMIS® is a set of person-centered measures that evaluates and monitors physical health in adults (T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population) a higher score (higher SD) indicates greater pain

  29. Pain measured through Patient Reported Outcomes Measurement Information System [PROMIS®]

    Time frame: 5 weeks after baseline

    PROMIS® is a set of person-centered measures that evaluates and monitors physical health in adults (T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population) a higher score (higher SD) indicates greater pain

  30. Pain measured through Patient Reported Outcomes Measurement Information System [PROMIS®]

    Time frame: 10 weeks after baseline

    PROMIS® is a set of person-centered measures that evaluates and monitors physical health in adults (T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population) a higher score (higher SD) indicates greater pain

  31. Post-traumatic stress measured through specific questionnaire

    Time frame: Baseline

    Post-traumatic Stress Disorder Checklist (PCL) which contains 20 items (PTSD intensity = total of 20 items, 0 to 4 scale) higher score indicates greater PTSD

  32. Post-traumatic stress measured through specific questionnaire

    Time frame: 5 weeks after baseline

    Post-traumatic Stress Disorder Checklist (PCL) which contains 20 items (PTSD intensity = total of 20 items, 0 to 4 scale) higher score indicates greater PTSD

  33. Post-traumatic stress measured through specific questionnaire

    Time frame: 10 weeks after baseline

    Post-traumatic Stress Disorder Checklist (PCL) which contains 20 items (PTSD intensity = total of 20 items, 0 to 4 scale) higher score indicates greater PTSD

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Acronym: EMBRACE

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 11, 2021
Registry last updated
Mar 22, 2024

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.

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