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

NCT05417867 | Recruiting

• 1 other identifier: 20-009279
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 5

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 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.

Conditions

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

Outcome Measures

Primary Outcomes (8)

• Number of patients approached

  Assessed using descriptive statistics.

  Up to 24 months

• Number of patients enrolled

  Assessed using descriptive statistics.

  Up to 24 months

• Number of patients who completed the questionnaires at both assessments

  Assessed using descriptive statistics.

  At baseline and 3-5 days after initiation of chemotherapy

• Number of patients who provided stool samples at both assessments

  Assessed using descriptive statistics.

  At baseline and 3-5 days after initiation of chemotherapy

• 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 fatigue or chemotherapy-induced nausea (CIN) at T2 as measured by questionnaire.

  Up to study completion

• Differences in demographic between patients who do and do not report fatigue and 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 fatigue and CIN will be evaluated.

  Up to study completion

• 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.

  Up to study completion

• 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.

  Up to study completion

Study Arms (1)

Observational

Patients undergo collection of stool and blood samples and complete questionnaires on study.

Procedure: Biospecimen Collection; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of stool and blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Observational

Questionnaire Administration OTHER

Complete questionnaires

Observational

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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, Minnesota, and Mayo Clinic Florida.

You may qualify if:

• 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

You may not qualify if:

• Metastatic disease
• Concurrent radiation therapy
• Concurrent antibiotic treatment

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (5)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

SUSPENDED

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

ACTIVE NOT RECRUITING

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, 56007, United States

RECRUITING

Mayo Clinic Health System in Mankato

Mankato, Minnesota, 56001, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

SUSPENDED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Brenda J. Ernst, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 14, 2022
• Study Start: April 14, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (5)