NCT05417867

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Evaluate the feasibility of patient recruitment and retention, as well as specimen collection. II. Estimate the effect size for changes in gut microbiome composition profiles and metabolites in stool as well as blood from time of first stool sample collection prior to chemotherapy (T1) to time of second stool sample collection after chemotherapy (T2) that are associated with the occurrence of fatigue and CIN. III. Evaluate associations between patient reported demographic and clinical characteristics, comorbidities at T1, and changes in gastrointestinal and neuropsychological symptoms, food intake as well as exercise from T1 to T2 with the occurrence of fatigue and CIN. OUTLINE: This is an observational study. Patients undergo collection of stool and blood samples and complete questionnaires on study.

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

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of stool and blood samples
OTHER	Questionnaire Administration	Complete questionnaires

Timeline

• Start date: 2021-04-14
• Primary completion: 2026-09-30
• Completion: 2027-03-31
• First posted: 2022-06-14
• Last updated: 2026-03-31

Locations

5 sites across 1 country: United States