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

The Gut Microbiome and Vasomotor Symptoms in Women with Estrogen Receptor-Positive Breast Cancer undergoing Endocrine Therapy

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12623001131640

Enrollment

200

Registered

2023-11-02

Start date

2023-11-07

Completion date

2027-08-31

Last updated

2023-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to identify gut bacteria that are associated with vasomotor symptoms, such as hot flushes, that affect quality of life for women with breast cancer. Who is it for? You may be eligible for this study if you are a female who has either been diagnosed with estrogen-receptor positive breast cancer postmenopausally and are due to receive endocrine therapy, or are a carer for a breast cancer patient. Study details While breast cancer patients undergo the standard 5 to 10-year regimen of endocrine therapy, participants will be requested to provide blood and stool samples, along with completing questionnaires before and during the treatment (at week 4-5 and week 12). Healthy caregivers in the control group will not undergo any treatment, however, they will be requested to provide samples and complete questionnaires at a single time point before the individual under their care undergoes endocrine therapy. It is hoped that findings from this novel study will help to identify key gut bacteria associated with vasomotor symptoms to improve the quality of life and increase the survival of breast cancer survivors.

Interventions

Endocrine Therapy- oral tablet for 5 years - Tamoxifen 20 mg once daily or - Anastrozole 1 mg once daily or - Letrozole 2..5 mg once daily or - Exemestane 25mg once daily, The patient's doctor will choose a suitable drug from the options available, based on the individual's pathology report. Participants will be requested to complete a quality of life questionnaire and provide blood and/or stool samples three times: before treatment and during treatment at week 4-5 and week 12.

Study design

Allocation

Non-randomised trial

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

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)).

Outcome results