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

Recruiting

• Conditions: Chemotherapy-Related Nausea and/or Vomiting; Early Stage Breast Carcinoma
• Interventions: Procedure: Biospecimen Collection; Other: Questionnaire Administration

• Registration Number: NCT05417867
• Lead Sponsor: Mayo Clinic

Brief 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.

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 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 Timeline

• Study Start: 2021-04-14
• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-06-10
• Study First Posted: 2022-06-14
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-26
• Primary Completion: 2025-09
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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, Arizona 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

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Exclusion Criteria

• Metastatic disease
• Concurrent radiation therapy
• Concurrent antibiotic treatment

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (survey, biospecimen collection)	Questionnaire Administration	Patients undergo collection of stool samples over 10 minutes and complete questionnaires over 60 minutes at baseline and 3-5 days following initiation of standard of care chemotherapy.
Observational (survey, biospecimen collection)	Biospecimen Collection	Patients undergo collection of stool samples over 10 minutes and complete questionnaires over 60 minutes at baseline and 3-5 days following initiation of standard of care chemotherapy.

Primary Outcome Measures

Name	Time	Method
Bacterial composition of stool samples	Up to study completion	All stool samples will be processed for deoxyribonucleic acid extraction. The hypervariable regions V3 and V4 of the bacterial 16S ribosomal ribonucleic acid (rRNA) gene will be sequenced to determine bacterial composition. After quality control, 16S rRNA reads will be analyzed to determine operational taxonomic units (OTU) for T1 and T2 samples using QIIME software. Alpha (within sample) diversity and beta (between sample) diversity will be analyzed using nonmetric multidimensional scaling ordination and the effect size for changes in OTUs in gut microbiome composition profiles from T1 to T2 in patients who do and do not report chemotherapy-induced nausea (CIN) at T2 as measured by questionnaire, will be determined using linear discriminant analysis effect size.
Number of patients who completed the questionnaires at both assessments	At baseline and 3-5 days after initiation of chemotherapy	Assessed using descriptive statistics.
Number of patients who provided stool samples at both assessments	At baseline and 3-5 days after initiation of chemotherapy	Assessed using descriptive statistics.
Differences in demographic between patients who do and do not report CIN	Up to study completion	Evaluated using parametric and non-parametric tests. The changes in gastrointestinal and neuropsychological symptoms, food intake as well as exercise from T1 to T2 associated with the occurrence of CIN will be evaluated using Kruskal-Wallis tests.
Differences in clinical characteristics between patients who do and do not report CIN	Up to study completion	Evaluated using parametric and non-parametric tests. The changes in gastrointestinal and neuropsychological symptoms, food intake as well as exercise from T1 to T2 associated with the occurrence of CIN will be evaluated using Kruskal-Wallis tests.
Differences in comorbidities between patients who do and do not report CIN	Up to study completion	Evaluated using parametric and non-parametric tests. The changes in gastrointestinal and neuropsychological symptoms, food intake as well as exercise from T1 to T2 associated with the occurrence of CIN will be evaluated using Kruskal-Wallis tests.
Number of patients approached	Up to 24 months	Assessed using descriptive statistics.
Number of patients enrolled	Up to 24 months	Assessed using descriptive statistics.

Trial Locations

Locations (3)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States