Recruiting

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

ClinicalTrials.gov IDNCT05417867

PhaseNot Applicable

Enrollment70

SponsorMayo Clinic

Age20 Years

SexALL

I'm interested View official listing

Conditions studied

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

About this study

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.

Interventions

Procedure: Biospecimen Collection — Undergo collection of stool and blood samples
Other: Questionnaire Administration — Complete questionnaires

Primary outcomes

Number of patients approached (Up to 24 months)
Number of patients enrolled (Up to 24 months)
Number of patients who completed the questionnaires at both assessments (At baseline and 3-5 days after initiation of chemotherapy)
Number of patients who provided stool samples at both assessments (At baseline and 3-5 days after initiation of chemotherapy)
Bacterial composition of stool samples (Up to study completion)
Differences in demographic between patients who do and do not report fatigue and CIN (Up to study completion)
Differences in clinical characteristics between patients who do and do not report CIN (Up to study completion)
Differences in comorbidities between patients who do and do not report CIN (Up to study completion)

Eligibility information

Inclusion Criteria: * Subjects with a diagnosis of early stage breast cancer planning to receive moderate to highly emetogenic chemotherapy will be recruited at Mayo Clinic Health Systems including Mankato and Albert Lea; Mayo Clinic Arizona; Mayo Clinic Rochester (Minnesota); and Mayo Clinic Florida * At least 20 years of age * Last chemotherapy more than 3 years ago * Scheduled to receive moderate to highly emetogenic chemotherapy with or without targeted therapies including immunotherapies Exclusion Criteria: * Metastatic disease * Concurrent radiation therapy * Concurrent antibiotic treatment

Study locations

Mayo Clinic in Arizona, Scottsdale, Arizona 85259 United States
Mayo Clinic in Florida, Jacksonville, Florida 32224-9980 United States
Mayo Clinic Health System in Albert Lea, Albert Lea, Minnesota 56007 United States
Mayo Clinic Health System in Mankato, Mankato, Minnesota 56001 United States
Mayo Clinic in Rochester, Rochester, Minnesota 55905 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.