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Aerobic Exercise for Breast Cancer Survivors (ROME Trial)

N/A
Recruiting
Led By Laura Q Rogers, MD, MPH
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 1-year post-completion of primary treatment for breast cancer (chemotherapy and/or radiation)
No antibiotics for the past 90 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks after baseline
Awards & highlights

ROME Trial Summary

This trial will test how well exercise affects the gut microbiome (bacteria in the digestive system) and fatigue in breast cancer survivors.

Who is the study for?
This trial is for women aged 18-74 who are breast cancer survivors (stage 0, I, II, or III) and have been free from primary treatment for at least a year. Participants should not be taking probiotics or antibiotics recently, must be able to walk without help, have low exercise capacity, experience fatigue, and get medical clearance.Check my eligibility
What is being tested?
The study aims to explore how aerobic exercise affects the gut microbiome in breast cancer survivors and its potential link to reducing fatigue. Participants will either engage in an aerobic exercise program or be part of an attention control group that does not receive this intervention.See study design
What are the potential side effects?
While specific side effects are not listed for this type of non-drug intervention, participants may experience general discomforts associated with new exercise routines such as muscle soreness or increased fatigue initially.

ROME Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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It's been over a year since I finished my initial breast cancer treatment.
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I haven't taken any antibiotics in the last 90 days.
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I can walk on my own without help.
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I have felt quite tired, rating my fatigue 3 or higher out of 10, over the last week.
Select...
I am a woman aged 18-74 with a history of early to mid-stage breast cancer.

ROME Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks after baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks after baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composition of gut microbiota as measured by fecal samples
Secondary outcome measures
Electrocardiogram
Concentration of cortisol measured through hair sample
Fatigue
+2 more
Other outcome measures
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
Absorptiometry, X-Ray
FACT-B self-administered survey measuring quality of life
+5 more

ROME Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Aerobic Exercise TrainingExperimental Treatment1 Intervention
Progressive aerobic exercise training sessions supervised by exercise specialists who have experience training cancer survivors.
Group II: Attention ControlActive Control1 Intervention
The non-aerobic exercise attention control condition will control for the effects of attention with flexibility/toning activities.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,269 Total Patients Enrolled
938 Trials studying Breast Cancer
1,543,217 Patients Enrolled for Breast Cancer
University of Alabama at BirminghamLead Sponsor
1,571 Previous Clinical Trials
2,269,285 Total Patients Enrolled
31 Trials studying Breast Cancer
4,365 Patients Enrolled for Breast Cancer
Laura Q Rogers, MD, MPHPrincipal InvestigatorUniversity of Alabama at Birmingham
3 Previous Clinical Trials
96 Total Patients Enrolled
1 Trials studying Breast Cancer
49 Patients Enrolled for Breast Cancer

Media Library

Aerobic Exercise Training Clinical Trial Eligibility Overview. Trial Name: NCT04088708 — N/A
Breast Cancer Research Study Groups: Aerobic Exercise Training, Attention Control
Breast Cancer Clinical Trial 2023: Aerobic Exercise Training Highlights & Side Effects. Trial Name: NCT04088708 — N/A
Aerobic Exercise Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT04088708 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are enrolled in this research project?

"Affirmative. According to the clinicaltrials.gov website, this investigation is currently enrolling subjects; it was published on January 17th 2020 and most recently revised on November 14th 2022. 126 participants are being accepted at one medical site."

Answered by AI

Who qualifies for inclusion in this research endeavor?

"To be eligible to join this medical trial, subjects have to display symptoms of fatigue and fall between 18-74 years old. Presently, the researchers are seeking 126 individuals for participation."

Answered by AI

Are there still opportunities for volunteers to take part in this investigation?

"This experiment is currently seeking participants, and the information posted on clinicaltrials.gov was first made available on 17th January 2020 with edits as recent as 14th November 2022."

Answered by AI

Is enrollment open to seniors for this inquiry?

"This chance to participate in the trial is limited to individuals between 18 and 74 years of age. Comparatively, there are 99 trials open for those below eighteen while 2720 studies are available for seniors above 65."

Answered by AI
~32 spots leftby Aug 2025