Evaluating the Effect of Endocrine Therapy on Gut Bacteria in Estrogen Receptor-Positive Breast Cancer

Not Applicable

• Conditions: Breast cancer; Hot flushes; Anxiety; Join pain and stiffness; Cancer - Breast

• Registration Number: ACTRN12623001131640
• Lead Sponsor: Royal North Shore Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-02
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Intervention group- breast cancer survivors:
•Postmenopausal women diagnosed with estrogen-positive breast cancer (BCa) and expecting to receive endocrine therapy.
•Life expectancy of >12 weeks.
•Patients able to provide biospecimens (stool and blood samples) and quality of life (QOL) data.
•Patients must be able to read and complete questionnaires in English.
•Capacity to understand the participant information sheet and consent form (PISCF) and the ability to provide written or electronic informed consent.

Control group- healthy participants;
•Caregivers at least 18 years of age; no upper age limit.
•Siblings or individuals cohabiting with the patient (e.g. roommate, partner), or a close friend.
• Able to read and complete questionnaires in English
•A carer is eligible to participate in this study regardless of whether the patient you are caring for is participating in the study or not.

Exclusion Criteria

Intervention group- breast cancer survivors:
•Patients unable to give informed consent.

Control group- heathy participants;
•Having taken antibiotics within 3 months prior to stool collection.
•Medical history of cancer.
•Current diagnosis/medication treatment for anxiety and/or depression.
•Diagnosis of irritable bowel syndrome/disease.
•Women who are pregnant.
•Diagnosis of a significant cognitive or developmental condition (e.g., Down syndrome, autism spectrum disorder (ASD)).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut microbiome profile assessed using shotgun metagenomic gene <br>sequencing of stool samples[ Three time points (Immediately before, and during (at week 4-5 and week 12-13) endocrine therapy).];Hot flushes will be assessed by the Hot Flushes Activity and Severity (HFAS) questionnaire.[ Three time points Immediately before, and during (at week 4-5 and week 12-13) endocrine therapy).]

Secondary Outcome Measures

Name	Time	Method
- Anxiety will be assessed by the Generalized Anxiety Disorder 2-items (GAD-2).<br><br><br>[ Three time points (Immediately before, and during (at week 4-5 and week 12-13) endocrine therapy).];Joint pain and stiffness will be assessed by the Brief Pain Inventory-Short Form (BPI).[ Three time points (Immediately before, and during (at week 4-5 and week 12-13) endocrine therapy).];Estrogen level: Super sensitive estradiol assay will be conducted with blood samples.[ Three time points (Immediately before, and during (at week 4-5 and week 12-13) endocrine therapy).]