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Association Between Changes in the Gut Microbiome and Chemotherapy-Induced Nausea in Stage I-III Breast Cancer

Early Stage Breast Carcinoma Clinical Trial

Official title:
A Pilot Study of the Associations Between Chemotherapy-Induced Nausea in Breast Cancer Patients and Gut Microbiome Composition Profiles

Clinical Trial Summary

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

Clinical Trial 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 T1 to T2 that are associated with the occurrence of 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 CIN. OUTLINE: Patients undergo collection of stool and blood samples and complete questionnaires at baseline and 3-5 days following initiation of standard of care chemotherapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05417867
Study type Observational
Source Mayo Clinic
Contact
Status Recruiting
Phase
Start date April 14, 2021
Completion date October 15, 2024
View Details
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