RECRUITING

Oral Aromatase Inhibitors Modify the Gut Microbiome

Conditions

Breast Cancer Gut microbiome Circulating sex hormone metabolite concentrations

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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

The purpose of this research is to study the bacteria in participants' gut before receiving a medicine called an aromatase inhibitor for breast cancer and after participants receive medicine for breast cancer.

Official Title

Oral Aromatase Inhibitors Modify the Gut Microbiome Effecting Estrogen Bioavailability

Quick Facts

Study Start:2022-03-29

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05030038

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:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Pathologic diagnosis in situ or invasive breast cancer for which initiating aromatase inhibitors therapy is recommended or initiating aromatase inhibitors for risk reduction. * ECOG performance status 0,1, 2, 3. * Age ≥ 18 years * HER2+ breast cancer is allowed if patients are on a monoclonal antibody therapy for which a change is not anticipated while on study (12 weeks) and they have been on the monoclonal antibody therapy for at least 4 weeks. * Ability to read, understand and evaluate study materials and willingness to sign a written informed consent document.	* Have been on antibiotics within 4 weeks of enrollment. * Administered chemotherapy less than 4 weeks prior to enrollment. * Hormone replacement (defined as only estrogen and/or progesterone replacement) or anti-estrogen therapy within 4 weeks of starting aromatase inhibitors * Use of antibody drug conjugate (HER2+ breast cancer) * Male breast cancer * Any serious and/or unstable pre-existing medical, psychiatric, or other existing condition that would prevent compliance with the trial or consent process

Inclusion Criteria

Exclusion Criteria

* Pathologic diagnosis in situ or invasive breast cancer for which initiating aromatase inhibitors therapy is recommended or initiating aromatase inhibitors for risk reduction.
* ECOG performance status 0,1, 2, 3.
* Age ≥ 18 years
* HER2+ breast cancer is allowed if patients are on a monoclonal antibody therapy for which a change is not anticipated while on study (12 weeks) and they have been on the monoclonal antibody therapy for at least 4 weeks.
* Ability to read, understand and evaluate study materials and willingness to sign a written informed consent document.

* Have been on antibiotics within 4 weeks of enrollment.
* Administered chemotherapy less than 4 weeks prior to enrollment.
* Hormone replacement (defined as only estrogen and/or progesterone replacement) or anti-estrogen therapy within 4 weeks of starting aromatase inhibitors
* Use of antibody drug conjugate (HER2+ breast cancer)
* Male breast cancer
* Any serious and/or unstable pre-existing medical, psychiatric, or other existing condition that would prevent compliance with the trial or consent process

Contacts and Locations

Study Contact

Study Coordinator

CONTACT

336-713-5435

jriley@wakehealth.edu

Principal Investigator

Katherine Ansley, MD

PRINCIPAL_INVESTIGATOR

Wake Forest Baptist Health Sciences

Study Locations (Sites)

Wake Forest Baptist Health Sciences

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Katherine Ansley, MD, PRINCIPAL_INVESTIGATOR, Wake Forest Baptist Health Sciences

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 Date2022-03-29

Study Completion Date2024-12

Study Record Updates

Study Start Date2022-03-29

Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

Gut microbiome
Circulating sex hormone metabolite concentrations

Additional Relevant MeSH Terms

Breast Cancer