Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    EMBRACE | cancer | Birmingham, Alabama, U.S.
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05000502
Recruitment Status : Recruiting
First Posted : August 11, 2021
Last Update Posted : October 21, 2021
Sponsor:
Information provided by (Responsible Party):
Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Female Breast Cancer Behavioral: Home-based exercise intervention Not Applicable

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 receive an energy-balanced, standardized diet. Assessments will occur at baseline and week 10 (post-intervention) by videoconference platform. Feasibility and changes in the gut microbiome will be assessed.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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 receive an energy-balanced, standardized diet.
Masking: Single (Outcomes Assessor)
Masking Description: Staff doing assessments will be masked to study group allocation
Primary Purpose: Other
Official Title: Exercise, Gut Microbiome, and Breast Cancer: Increasing Reach to Underserved Populations
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Home-based aerobic exercise training
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
A 10-week home-based exercise intervention including weekly video conferences with exercise specialists.

Active Comparator: Home-based standard attention flexibility/toning control
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
A 10-week home-based exercise intervention including weekly video conferences with exercise specialists.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women
  • Age 18-70 years
  • History of breast cancer stage I, II, or III
  • ≥1 year post-primary cancer treatment completion
  • English speaking
  • Physician medical clearance
  • 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.)

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
  • Participating in >20 minutes of exercise on ≥2 days/week in the past six months
  • Anticipate elective surgery, medication changes or antibiotics during the study
  • Contraindication to ≥moderate intensity aerobic exercise
  • Pregnant or anticipate pregnancy during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05000502


Contacts
Layout table for location contacts
Contact: Laura Rogers, MD 2059349735 lqrogers@uabmc.edu

Locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Victoria Roughsedge, RD       vlroughsedge@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Layout table for investigator information
Principal Investigator: Laura Rogers, MD University of Alabama at Birmingham
Layout table for additonal information
Responsible Party: Laura Q. Rogers, MD, MPH, Professor, Med - Preventive Medicine, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT05000502    
Other Study ID Numbers: 300007016
First Posted: August 11, 2021    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share participant data.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham:
Exercise
Gut Microbiome
Breast Cancer
Cancer
Aerobic Exercise
Microbiome
Female Breast Cancer
Flexibility Exercise
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases