Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT05417867

Conditions

Chemotherapy-Related Nausea and/or Vomiting

Early Stage Breast Carcinoma

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Questionnaire Administration

Study Details

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

Chemotherapy-Related Nausea and/or Vomiting

Early Stage Breast Carcinoma

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer AJCC v8

Study ID

NCT05417867

Start date

Apr 14, 2021

Status verified date

Mar, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

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 Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

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

Interventions

Biospecimen Collection

Undergo collection of stool and blood samples

Questionnaire Administration

Complete questionnaires

Primary outcome measure

  • Number of patients approached [ Time Frame: Up to 24 months ]
  • Number of patients enrolled [ Time Frame: Up to 24 months ]
  • Number of patients who completed the questionnaires at both assessments [ Time Frame: At baseline and 3-5 days after initiation of chemotherapy ]
  • Number of patients who provided stool samples at both assessments [ Time Frame: At baseline and 3-5 days after initiation of chemotherapy ]
  • Bacterial composition of stool samples [ Time Frame: Up to study completion ]
  • Differences in demographic between patients who do and do not report fatigue and CIN [ Time Frame: Up to study completion ]
  • Differences in clinical characteristics between patients who do and do not report CIN [ Time Frame: Up to study completion ]
  • Differences in comorbidities between patients who do and do not report CIN [ Time Frame: Up to study completion ]

Central Contacts and Locations

Locations

Mayo Clinic Health System in Albert Lea

Recruiting

Albert Lea, Minnesota, United States, 56007

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Mina Hanna, MD

Mayo Clinic Health System in Mankato

Recruiting

Mankato, Minnesota, United States, 56001

Contacts

Clinical Trials Referral Office

612-624-2620mayocliniccancerstudies@mayo.edu

Principal Investigator:

Amrit B. Singh, MBBS

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 31, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-31.