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

Mayo Clinic

Status

Enrolling

Conditions

Chemotherapy-Related Nausea and/or Vomiting

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage I Breast Cancer AJCC v8

Early Stage Breast Carcinoma

Treatments

Procedure: Biospecimen Collection

Other: Questionnaire Administration

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT05417867

NCI-2022-01231 (Registry Identifier)

20-009279 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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