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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT05417867
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of stool and blood samples
  • Questionnaire Administration — OTHER
    Complete questionnaires

Study Details

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.

Key Dates

Start date
Apr 14, 2021
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
70 participants (estimated)

Arms

  • Arm: Observational
    Patients undergo collection of stool and blood samples and complete questionnaires on study.

Primary Outcome Measure

Number of patients approached [ Time Frame: Up to 24 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259-
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
Mayo Clinic Health System in Albert LeaAlbert LeaMinnesota56007
Clinical Trials Referral Office
[email protected]
855-776-0015
Mina Hanna, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Health System in MankatoMankatoMinnesota56001
Clinical Trials Referral Office
[email protected]
612-624-2620
Amrit B. Singh, MBBS (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905-

Find similar trials in Scottsdale, AZ

By research site
Mayo Clinic in Arizona· Scottsdale, AZMayo Clinic in Florida· Jacksonville, FLMayo Clinic Health System in Albert Lea· Albert Lea, MNMayo Clinic Health System in Mankato· Mankato, MNMayo Clinic in Rochester· Rochester, MN

Related Studies