Breast CancerROMENCT04088708
Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors
A study testing Aerobic Exercise Training in people with Breast Cancer and Gut Microbiome, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years, women only
- Conditions the study is for
- Breast Cancer, Gut Microbiome, Exercise
- What is being tested?
- Aerobic Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2020to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294-001
About this study
Official title: Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME Study)
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.
Read the 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.
- Conditions
- Breast Cancer, Gut Microbiome, Exercise, Fatigue
- Being tested
- Aerobic Exercise Training, Attention Control
- Keywords
- breast cancer, fatigue, exercise, psychosocial outcomes, inflammation, gut microbiome
- Medical subject headings
- Breast Neoplasms, Motor Activity, Fatigue, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise TrainingOther
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 ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Training | Experimental | Progressive aerobic exercise training sessions supervised by exercise specialists who have experience training cancer survivors. Receives: Other: Aerobic Exercise Training |
| Attention Control | Active comparator | The non-aerobic exercise attention control condition will control for the effects of attention with flexibility/toning activities. Receives: Other: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition of gut microbiota as measured by fecal samples
Using standard diversity and taxa comparison metrics
Measured: Baseline
Composition of gut microbiota as measured by fecal samples
Using standard diversity and taxa comparison metrics
Measured: 5 weeks after baseline
Composition of gut microbiota as measured by fecal samples
Using standard diversity and taxa comparison metrics
Measured: 10 weeks after baseline
Composition of gut microbiota as measured by fecal samples
Using standard diversity and taxa comparison metrics
Measured: 15 weeks after baseline
Secondary outcomes (16)
Systemic inflammation tested via blood biomarkers
Blood samples will be analyzed for markers of inflammation (IL-6, IL-10)
Measured: Baseline
Systemic inflammation tested via blood biomarkers
Blood samples will be analyzed for markers of inflammation (IL-6, IL-10)
Measured: 5 weeks after baseline
Systemic inflammation tested via biomarkers
Blood samples will be analyzed for markers of inflammation (IL-6, IL-10)
Measured: 10 weeks after baseline
Systemic inflammation tested via blood biomarkers
Blood samples will be analyzed for markers of inflammation (IL-6, IL-10)
Measured: 15 weeks after baseline
Autonomic nervous system measured through non-invasive ECG
Using a Actiheart 5 to measure heart rate variability and impedance cardiography while resting quietly
Measured: Baseline
Autonomic nervous system measured through non-invasive ECG
Using a Actiheart 5 to measure heart rate variability and impedance cardiography while resting quietly
Measured: 5 weeks after baseline
Autonomic nervous system measured through non-invasive ECG
Using a Actiheart 5 to measure heart rate variability and impedance cardiography while resting quietly
Measured: 10 weeks after baseline
Autonomic nervous system measured through non-invasive ECG
Using a Actiheart 5 to measure heart rate variability and impedance cardiography while resting quietly
Measured: 15 weeks after baseline
Concentration of cortisol measured through hair sample
Hormone change that is associated with stress
Measured: Baseline
Concentration of cortisol measured through hair sample
Hormone change that is associated with stress
Measured: 5 weeks after baseline
Concentration of cortisol measured through hair sample
Hormone change that is associated with stress
Measured: 10 weeks after baseline
Concentration of cortisol measured through hair sample
Hormone change that is associated with stress
Measured: 15 weeks after baseline
Fatigue measured through fatigue specific questionnaire
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
Measured: Baseline
Fatigue measured through fatigue specific questionnaire
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
Measured: 5 weeks after baseline
Fatigue measured through fatigue specific questionnaire
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
Measured: 10 weeks after baseline
Fatigue measured through fatigue specific questionnaire
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
Measured: 15 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start17 Jan 2020
- Primary completion5 Sep 2025
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham
- Investigators
- Laura Q Rogers, MD, MPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088708
- Sponsor's protocol ID
- IRB-30000320
- Other IDs
- R01CA235598
- Acronym
- ROME
- Status last verified
- Sep 2025
- First submitted
- 3 Aug 2019
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Any data collected with National Institutes of Health (NIH) funding and made public through publication in a peer-reviewed format will thereafter be available on request to faculty of institutions with Public Health Service (PHS) assurance. For sharing data and specimens from individual human subjects, the investigators will comply with all relevant policies including the "Standards for Privacy of Individually Identifiable Health Information" rule of the Health Insurance Portability and Accountability Act (HIPAA). For sharing data, the investigators will comply with the requirements of the Final NIH Statement on Sharing Research Data (NOT-OD-03-032), the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) (NOT-OD-07-088), the NIH Genomic Data Sharing Policy (NOT-OD-14-124), and all other existing, updated, and new requirements as stated by NIH policy.
Publications
Little RB, Carter SJ, Motl RW, Hunter G, Cook A, Liu N, Krontiras H, Lefkowitz EJ, Turan B, Schleicher E, Rogers LQ. Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME) study: protocol for a randomised controlled trial. BMJ Open. 2024 May 3;14(5):e081660. doi: 10.1136/bmjopen-2023-081660.
PubMed 38702085
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME Study)
- ClinicalTrials.gov ID
- NCT04088708
- Acronym / sponsor ID
- ROME / IRB-30000320
- Conditions
- Breast Cancer, Gut Microbiome, Exercise, Fatigue
- Keywords
- breast cancer, fatigue, exercise, psychosocial outcomes, inflammation, gut microbiome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 13 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Training | Experimental | Other: Aerobic Exercise TrainingProgressive aerobic exercise training sessions supervised by exercise specialists who have experience training cancer survivors. |
| Attention Control | Active comparator | Other: Attention ControlThe non-aerobic exercise attention control condition will control for the effects of attention with flexibility/toning activities. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise TrainingEach 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. | Other | Aerobic Exercise Training |
| Attention ControlThe 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. | Other | Attention Control |
Primary outcome
Composition of gut microbiota as measured by fecal samples
Time frame: Baseline
Using standard diversity and taxa comparison metrics
Composition of gut microbiota as measured by fecal samples
Time frame: 5 weeks after baseline
Using standard diversity and taxa comparison metrics
Composition of gut microbiota as measured by fecal samples
Time frame: 10 weeks after baseline
Using standard diversity and taxa comparison metrics
Composition of gut microbiota as measured by fecal samples
Time frame: 15 weeks after baseline
Using standard diversity and taxa comparison metrics
16 secondary outcomes
Systemic inflammation tested via blood biomarkers
Time frame: Baseline
Systemic inflammation tested via blood biomarkers
Time frame: 5 weeks after baseline
Systemic inflammation tested via biomarkers
Time frame: 10 weeks after baseline
Systemic inflammation tested via blood biomarkers
Time frame: 15 weeks after baseline
Autonomic nervous system measured through non-invasive ECG
Time frame: Baseline
Autonomic nervous system measured through non-invasive ECG
Time frame: 5 weeks after baseline
Autonomic nervous system measured through non-invasive ECG
Time frame: 10 weeks after baseline
Autonomic nervous system measured through non-invasive ECG
Time frame: 15 weeks after baseline
Concentration of cortisol measured through hair sample
Time frame: Baseline
Concentration of cortisol measured through hair sample
Time frame: 5 weeks after baseline
Concentration of cortisol measured through hair sample
Time frame: 10 weeks after baseline
Concentration of cortisol measured through hair sample
Time frame: 15 weeks after baseline
Fatigue measured through fatigue specific questionnaire
Time frame: Baseline
Fatigue measured through fatigue specific questionnaire
Time frame: 5 weeks after baseline
Fatigue measured through fatigue specific questionnaire
Time frame: 10 weeks after baseline
Fatigue measured through fatigue specific questionnaire
Time frame: 15 weeks after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Derived from this study: PubMed 38702085Little RB, Carter SJ, Motl RW, Hunter G, Cook A, Liu N, Krontiras H, Lefkowitz EJ, Turan B, Schleicher E, Rogers LQ. Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME) study: protocol for a randomised controlled trial. BMJ Open. 2024 May 3;14(5):e081660. doi: 10.1136/bmjopen-2023-081660.
- Individual participant dataSharing planned: Yes. Any data collected with National Institutes of Health (NIH) funding and made public through publication in a peer-reviewed format will thereafter be available on request to faculty of institutions with Public Health Service (PHS) assurance. For sharing data and specimens from individual human subjects, the investigators will comply with all relevant policies including the "Standards for Privacy of Individually Identifiable Health Information" rule of the Health Insurance Portability and Accountability Act (HIPAA). For sharing data, the investigators will comply with the requirements of the Final NIH Statement on Sharing Research Data (NOT-OD-03-032), the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) (NOT-OD-07-088), the NIH Genomic Data Sharing Policy (NOT-OD-14-124), and all other existing, updated, and new requirements as stated by NIH policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Q Rogers, MD, MPH principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise Training in people with Breast Cancer and Gut Microbiome, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composition of gut microbiota as measured by fecal samples (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04088708, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.