Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05417867 | RECRUITING | Chemotherapy-Related Nausea and/or Vomiting

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

Condition or disease

Chemotherapy-Related Nausea and/or Vomiting

Early Stage Breast Carcinoma

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer Ajc V8

Intervention/treatment

Biospecimen Collection

Questionnaire Administration

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
Estimated Enrollment : 70 participants
Official Title : Associations of Fatigue and Chemotherapy-Induced Nausea With Changes in Gut Microbiome Composition Profiles
Actual Study Start Date : 2021-04-14
Estimated Primary Completion Date : 2025-09
Estimated Study Completion Date : 2026-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 20 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Evaluating the Association Between Changes in the Gut Microbiome, Fatigue, and Chemotherapy-Induced Nausea in Early Stage Breast Cancer

Location Details

NCT05417867

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

SUSPENDED

United States, Arizona

Mayo Clinic in Arizona

Scottsdale, Arizona, United States, 85259

ACTIVE NOT RECRUITING

United States, Florida

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224-9980

RECRUITING

United States, Minnesota

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, United States, 56007

RECRUITING

United States, Minnesota

Mayo Clinic Health System in Mankato

Mankato, Minnesota, United States, 56001

SUSPENDED

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905