TERMINATED

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study evaluates the relationship between alterations in the GI microbiome and GI inflammation on symptom burden in women with breast cancer receiving chemotherapy.

Official Title

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

Quick Facts

Study Start:2024-03-22

Study Completion:2024-11-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06238986

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Female with a new diagnosis of breast cancer (stage I-III) * Age 20 or older * Able to read and write in English * Chemotherapy naive and beginning the first cycle of moderately or highly emetogenic chemotherapy (For example, Taxotere + cyclophosphamide treatment +/- trastuzumab). Patients who have not received chemotherapy for five years or more are considered chemotherapy naive	* Metastatic disease * Cognitive impairment, based on clinician assessment, that would prevent completing measures * Concurrent radiation therapy or radiation therapy within the last three months * GI co-morbidities (i.e., irritable bowel syndrome, gastroesophageal reflux disease) or bowel surgery within the last three months * A stoma preventing stool collection from the large intestine (i.e., ileostomy)

Inclusion Criteria

Exclusion Criteria

* Female with a new diagnosis of breast cancer (stage I-III)
* Age 20 or older
* Able to read and write in English
* Chemotherapy naive and beginning the first cycle of moderately or highly emetogenic chemotherapy (For example, Taxotere + cyclophosphamide treatment +/- trastuzumab). Patients who have not received chemotherapy for five years or more are considered chemotherapy naive

* Metastatic disease
* Cognitive impairment, based on clinician assessment, that would prevent completing measures
* Concurrent radiation therapy or radiation therapy within the last three months
* GI co-morbidities (i.e., irritable bowel syndrome, gastroesophageal reflux disease) or bowel surgery within the last three months
* A stoma preventing stool collection from the large intestine (i.e., ileostomy)

Contacts and Locations

Principal Investigator

Komal P. Singh, PhD, RN

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259

United States

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Komal P. Singh, PhD, RN, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-22

Study Completion Date2024-11-18

Study Record Updates

Study Start Date2024-03-22

Study Completion Date2024-11-18

Terms related to this study

Additional Relevant MeSH Terms

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