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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 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.

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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.

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

FieldValue
Enrollment Target 70 participants
Start Date 2021-04-14
Est. Completion 2027-03

Sponsor

Mayo Clinic

2,844 total trials

What the Registry Record Tells You About NCT05417867

The ClinicalTrials.gov registry entry for NCT05417867 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 355-participant average among 73 other Anatomic Stage II Breast Cancer AJCC v8 trials with a reported enrollment target (80% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

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 reports 5 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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