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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Metastatic disease

Concurrent radiation therapy

Concurrent antibiotic treatment

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of stool and blood samples

  • Questionnaire Administration

    Other intervention

    Complete questionnaires

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: Observational2 interventions

Trial outcomes

Primary outcomes

1

Number of patients approached

Assessed using descriptive statistics.

Time frame
Up to 24 months
2

Number of patients enrolled

Assessed using descriptive statistics.

Time frame
Up to 24 months
3

Number of patients who completed the questionnaires at both assessments

Assessed using descriptive statistics.

Time frame
At baseline and 3-5 days after initiation of chemotherapy
4

Number of patients who provided stool samples at both assessments

Assessed using descriptive statistics.

Time frame
At baseline and 3-5 days after initiation of chemotherapy

Secondary outcomes

Other outcomes

Sponsors and contacts

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