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Observational Study on Gut Microbiome, Fatigue, and Nausea in Early Breast Cancer

This study is looking at how changes in the bacteria in your gut (gut microbiome) might be linked to feeling tired (fatigue) and having nausea caused by chemotherapy in people with early-stage breast cancer. Many people experience fatigue or nausea during chemotherapy, but we don't fully understand why some people have it more than others. Researchers believe that changes in your gut microbiome could play a role. If you have early-stage breast cancer and are planning to receive chemotherapy, you might be able to join. The study involves collecting stool and blood samples, and filling out questionnaires. The main goal is to see how many people can be recruited and stay in the study, and to estimate how much the gut microbiome changes in relation to fatigue and nausea.

Study design
This is an observational study aiming to enroll 70 participants. It will look at how changes in the gut microbiome are associated with fatigue and chemotherapy-induced nausea.
What's involved
You would provide stool and blood samples and complete questionnaires at the start of chemotherapy and again 3-5 days after starting chemotherapy.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the number of patients approached and enrolled for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05417867

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

Recruiting
Not specifiedAges 20+Observational
Mayo Clinic
~70 participants
Updated 2026-03-31 on ClinicalTrials.gov
What's tested:Biospecimen CollectionQuestionnaire Administration

At a glance

Recruiting sites
2 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients approached
Measured over Up to 24 months
+7 more outcomes measured

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

Explore related trials

Breast Carcinoma

Where it's being run

5 sites across 3 states
Minnesota3
Arizona1
Florida1

Study leadership

  • Brenda J. Ernst, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Eligibility criteria

Inclusion

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

Metastatic disease
Concurrent radiation therapy
Concurrent antibiotic treatment

What this trial measures

  • Number of patients approachedUp to 24 months

    Assessed using descriptive statistics.

  • Number of patients enrolledUp to 24 months

    Assessed using descriptive statistics.

  • Number of patients who completed the questionnaires at both assessmentsAt baseline and 3-5 days after initiation of chemotherapy

    Assessed using descriptive statistics.

  • Number of patients who provided stool samples at both assessmentsAt baseline and 3-5 days after initiation of chemotherapy

    Assessed using descriptive statistics.

  • Bacterial composition of stool samplesUp to study completion

    All stool samples will be processed for deoxyribonucleic acid extraction. The hypervariable regions V3 and V4 of the bacterial 16S ribosomal ribonucleic acid (rRNA) gene will be sequenced to determine bacterial composition. After quality control, 16S rRNA reads will be analyzed to determine operational taxonomic units (OTU) for T1 and T2 samples using QIIME software. Alpha (within sample) diversity and beta (between sample) diversity will be analyzed using nonmetric multidimensional scaling ordination and the effect size for changes in OTUs in gut microbiome composition profiles from T1 to T2 in patients who do and do not report fatigue or chemotherapy-induced nausea (CIN) at T2 as measured by questionnaire.

  • Differences in demographic between patients who do and do not report fatigue and CINUp to study completion

    Evaluated using parametric and non-parametric tests. The changes in gastrointestinal and neuropsychological symptoms, food intake as well as exercise from T1 to T2 associated with the occurrence of fatigue and CIN will be evaluated.

  • Differences in clinical characteristics between patients who do and do not report CINUp to study completion

    Evaluated using parametric and non-parametric tests. The changes in gastrointestinal and neuropsychological symptoms, food intake as well as exercise from T1 to T2 associated with the occurrence of CIN will be evaluated.

  • Differences in comorbidities between patients who do and do not report CINUp to study completion

    Evaluated using parametric and non-parametric tests. The changes in gastrointestinal and neuropsychological symptoms, food intake as well as exercise from T1 to T2 associated with the occurrence of CIN will be evaluated.