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

NCT05417867 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2026-03-31

No results posted yet for this study

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.

Conditions

  • Chemotherapy-Related Nausea and/or Vomiting
  • Early Stage Breast Carcinoma
  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of stool and blood samples

OTHER

Questionnaire Administration

Complete questionnaires

Sponsors & Collaborators

Principal Investigators

  • Brenda J. Ernst, MD · Mayo Clinic

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-14
Primary Completion
2026-09-30
Completion
2027-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05417867 on ClinicalTrials.gov