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

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.

Study Overview

• Status: Recruiting
• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Early Stage Breast Carcinoma; Chemotherapy-Related Nausea and/or Vomiting
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Biospecimen Collection

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.

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Suspended
      • Mayo Clinic in Arizona
  • Florida
    • Jacksonville, Florida, United States, 32224-9980
      • Active, not recruiting
      • Mayo Clinic in Florida
  • Minnesota
    • Albert Lea, Minnesota, United States, 56007
      • Recruiting
      • Mayo Clinic Health System in Albert Lea
      • Principal Investigator: Mina Hanna, MD
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
    • Mankato, Minnesota, United States, 56001
      • Recruiting
      • Mayo Clinic Health System in Mankato
      • Contact: Clinical Trials Referral Office; Phone Number: 612-624-2620; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Amrit B. Singh, MBBS
    • Rochester, Minnesota, United States, 55905
      • Suspended
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 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

Exclusion Criteria:

• Metastatic disease
• Concurrent radiation therapy
• Concurrent antibiotic treatment

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational; Patients undergo collection of stool and blood samples and complete questionnaires on study.	Other: Questionnaire Administration; Complete questionnaires; Procedure: Biospecimen Collection; Undergo collection of stool and blood samples; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Brenda J. Ernst, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Signs and Symptoms, Digestive; Skin Diseases; Breast Diseases; Breast Neoplasms; Nausea; Vomiting; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling
• Other Study ID Numbers: 20-009279; NCI-2022-01231 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No