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NCT05417867 · ClinicalTrials.gov registry record
Evaluating the Association Between Changes in the Gut Microbiome, Fatigue, and Chemotherapy-Induced Nausea in Early Stage Breast Cancer
A clinical trial of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- 70
- Enrollment target
- 5
- Study locations
NCT05417867: Recruiting study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, sponsored by Mayo Clinic.
NCT05417867 is a study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8 that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 70 participants, below the 355-participant average among 73 other Anatomic Stage II Breast Cancer AJCC v8 trials with a reported enrollment target (80% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05417867, a study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- 70 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
Assessed using descriptive statistics.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Questionnaire Administration
Study Locations (5)
Minnesota
- Mayo Clinic Health System in Albert Lea - Albert Lea
- Mayo Clinic Health System in Mankato - Mankato
- Mayo Clinic in Rochester - Rochester
Arizona
- Mayo Clinic in Arizona - Scottsdale
Florida
- Mayo Clinic in Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2021-04-14 |
| Est. Completion | 2027-03 |
What NCT05417867 shows while recruiting
NCT05417867 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 355-participant average among 73 other Anatomic Stage II Breast Cancer AJCC v8 trials with a reported enrollment target (80% lower).
The record links to 4 conditions, with Anatomic Stage II Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which Biospecimen Collection is the first listed.
NCT05417867 lists 5 locations in 3 states (Minnesota, Arizona, Florida).
Frequently Asked Questions
What is clinical trial NCT05417867 about?
NCT05417867 is a clinical study titled "Evaluating the Association Between Changes in the Gut Microbiome, Fatigue, and Chemotherapy-Induced Nausea in Early Stage Breast Cancer". 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 ...
What is the current status of trial NCT05417867?
This trial is currently recruiting. The enrollment target is 70 participants. The study started on 2021-04-14. Estimated completion is 2027-03.
What conditions does trial NCT05417867 study?
This clinical trial studies the following conditions: Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Early Stage Breast Carcinoma, Chemotherapy-Related Nausea and/or Vomiting.
What interventions are being tested in trial NCT05417867?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Questionnaire Administration (OTHER).
Who is sponsoring clinical trial NCT05417867?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05417867 being conducted?
This trial has 5 study locations across Arizona, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05417867's enrollment target sits among peer trials
70 40th of 73 higher than 34 of 73 other Anatomic Stage II Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage II Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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