Actively Recruiting

Age: 20Years +
All Genders
NCT05417867

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

Led by Mayo Clinic · Updated on 2026-03-31

70

Participants Needed

5

Research Sites

311 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of early stage breast cancer and planning to receive moderate to highly emetogenic chemotherapy
  • At least 20 years old
  • Last chemotherapy was more than 3 years ago
  • Scheduled to receive moderate to highly emetogenic chemotherapy with or without targeted therapies including immunotherapies
Not Eligible

You will not qualify if you...

  • Presence of metastatic disease
  • Receiving concurrent radiation therapy
  • Receiving concurrent antibiotic treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Mayo Clinic in Arizona

Scottsdale, Arizona, United States, 85259

Suspended

2

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224-9980

Active, Not Recruiting

3

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, United States, 56007

Actively Recruiting

4

Mayo Clinic Health System in Mankato

Mankato, Minnesota, United States, 56001

Actively Recruiting

5

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Suspended

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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