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Aerobic Exercise for Breast Cancer Survivors (ROME Trial)
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.
ROME Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowROME Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ROME Trial Design
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Who is running the clinical trial?
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- I have unstable chest pain.I am planning to have surgery during the study.You have dementia or a brain disorder.I expect to need antibiotics during the study.I have not been diagnosed with any cancer other than skin or cervical cancer in situ in the past 5 years.I have heart failure that affects my daily activities.I live or work more than 50 miles away from the study site or I can't get there.My BMI is over 50.I am currently taking steroids.My cancer has spread or come back.It's been over a year since I finished my initial breast cancer treatment.I haven't taken any antibiotics in the last 90 days.I can walk on my own without help.You have a health condition that makes it unsafe for you to do intense aerobic exercise.You have schizophrenia or are currently experiencing hallucinations or delusions.Your peak VO2 (a measure of how well your body uses oxygen) is below 30 ml/kg/min.I have felt quite tired, rating my fatigue 3 or higher out of 10, over the last week.My asthma is not well-managed.I have interstitial lung disease.I am a woman aged 18-74 with a history of early to mid-stage breast cancer.I have a diagnosed connective tissue or rheumatologic disease.
- Group 1: Aerobic Exercise Training
- Group 2: Attention Control
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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