Ignite Creation Date:
2025-12-25 @ 12:30 AM
Ignite Modification Date:
2025-12-31 @ 12:48 PM
Study NCT ID:
NCT05417867
Status:
RECRUITING
Last Update Posted:
2025-10-27
First Post:
2022-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Association Between Changes in the Gut Microbiome, Fatigue, and Chemotherapy-Induced Nausea in Early Stage Breast Cancer
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Associations of Fatigue and Chemotherapy-Induced Nausea With Changes in Gut Microbiome Composition Profiles
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2022-01231 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |