RecruitingNCT05417867

Evaluating the Association Among Changes in Gut Microbiome, Fatigue, and Chemotherapy-Induced Nausea in Early Stage Breast Cancer

Associations of Fatigue and Chemotherapy-Induced Nausea With Changes in Gut Microbiome Composition Profiles


Sponsor

Mayo Clinic

Enrollment

70 participants

Start Date

Apr 14, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

This pilot study seeks to understand how changes in the bacteria composition (microbiome) of the gut may be associated with the occurrence of fatigue and chemotherapy-induced nausea (CIN) in women undergoing chemotherapy for early stage breast cancer. Patients undergoing chemotherapy may experience fatigue or nausea as a result of their treatment. Known risk factors for fatigue and CIN do not explain the differences in fatigue and CIN occurrence between patients, but changes in the functions of the gut microbiome may be related to the occurrence of fatigue and CIN. This study collects stool samples from breast cancer patients before and after chemotherapy to evaluate how changes in the microbiome may be associated with fatigue and CIN.


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether changes in the gut microbiome (the community of bacteria in the digestive tract) are linked to nausea and fatigue during chemotherapy in people with early-stage breast cancer. Understanding this connection may help develop ways to reduce these distressing side effects. **You may be eligible if...** - You have been diagnosed with early-stage breast cancer - You are scheduled to receive chemotherapy that has a moderate to high risk of causing nausea (emetogenic chemotherapy) - You are being treated at a Mayo Clinic site **You may NOT be eligible if...** - You have received prior chemotherapy for breast cancer - You have a chronic gastrointestinal condition (like Crohn's disease or IBS) - You have taken antibiotics recently (usually within 30 days) - You use probiotics regularly - You are pregnant Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo collection of stool and blood samples

OTHERQuestionnaire Administration

Complete questionnaires


Locations(5)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, United States

Mayo Clinic Health System in Mankato

Mankato, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

View Full Details on ClinicalTrials.gov

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NCT05417867


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