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 Details — Status: Recruiting

Administrative data

• NCT number: NCT05417867
• Other study ID #: 20-009279
• Secondary ID: NCI-2022-01231
• Status: Recruiting
• Start date: April 14, 2021
• Est. completion date: October 15, 2024

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 15, 2024
• Est. primary completion date: April 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Exclusion Criteria:

• Metastatic disease
• Concurrent radiation therapy
• Concurrent antibiotic treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Early Stage Breast Carcinoma
• Nausea
• Vomiting

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of stool and blood samples

Other:
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients approached	Assessed using descriptive statistics.	Up to 24 months
Primary	Number of patients enrolled	Assessed using descriptive statistics.	Up to 24 months
Primary	Number of patients who completed the questionnaires at both assessments	Assessed using descriptive statistics.	At baseline and 3-5 days after initiation of chemotherapy
Primary	Number of patients who provided stool samples at both assessments	Assessed using descriptive statistics.	At baseline and 3-5 days after initiation of chemotherapy
Primary	Bacterial composition of stool samples	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.	Up to study completion
Primary	Differences in demographic between patients who do and do not report CIN	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.	Up to study completion
Primary	Differences in clinical characteristics between patients who do and do not report CIN	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.	Up to study completion
Primary	Differences in comorbidities between patients who do and do not report CIN	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.	Up to study completion

External Links

•   Mayo Clinic Clinical Trials