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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-14

Study Completion Date

2027-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Relationship Between Alterations in the GI Microbiome and GI Inflammation on Symptom Burden in Women With Breast Cancer Receiving Chemotherapy

NCT06238986

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8

TERMINATED

Effects of Chemotherapy on Intestinal Bacteria in Patients With Newly Diagnosed Breast Cancer

NCT02370277

Ductal Breast Carcinoma In Situ Invasive Breast Carcinoma Stage I Breast Cancer +3 more

COMPLETED

Relationship Between Gut Microbiome and Adjuvant Chemotherapy in Patients With Early Breast Cancer

NCT03702868

Breast Cancer Adjuvant Chemotherapy

TERMINATED

Gut Microbiome Components Predict Response to Neoadjuvant Therapy in HER2-positive Breast Cancer Patients : A Prospective Study

NCT05444647

Breast Cancer

UNKNOWN

Gut and Intratumoral Microbiome Effect on the Neoadjuvant Chemotherapy-induced Immunosurveillance in Triple Negative Breast Cancer

NCT03586297

Triple Negative Breast Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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 Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Observational

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

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of stool and blood samples

Questionnaire Administration

Intervention Type OTHER

Complete questionnaires

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biospecimen Collection

Undergo collection of stool and blood samples

Intervention Type PROCEDURE

Questionnaire Administration

Complete questionnaires

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Biological Sample Collection Biospecimen Collected Specimen Collection

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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