Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001131640
Ethics application status
Approved
Date submitted
22/08/2023
Date registered
2/11/2023
Date last updated
2/11/2023
Date data sharing statement initially provided
2/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the Effect of Endocrine Therapy on Gut Bacteria in Estrogen Receptor-Positive Breast Cancer
Scientific title
The Gut Microbiome and Vasomotor Symptoms in Women with Estrogen Receptor-Positive Breast Cancer undergoing Endocrine Therapy
Secondary ID [1] 310441 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 331224 0
Hot flushes 331790 0
Anxiety 331791 0
Join pain and stiffness 331792 0
Condition category
Condition code
Cancer 328528 328528 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 326842 0
Prevention
Intervention code [2] 326843 0
Treatment: Drugs
Comparator / control treatment
Caregivers will not receive 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.
Control group
Active

Outcomes
Primary outcome [1] 335838 0
Gut microbiome profile assessed using shotgun metagenomic gene
sequencing of stool samples
Timepoint [1] 335838 0
Three time points (Immediately before, and during (at week 4-5 and week 12-13) endocrine therapy).
Primary outcome [2] 335839 0
Hot flushes will be assessed by the Hot Flushes Activity and Severity (HFAS) questionnaire.
Timepoint [2] 335839 0
Three time points Immediately before, and during (at week 4-5 and week 12-13) endocrine therapy).
Secondary outcome [1] 425856 0
- Anxiety will be assessed by the Generalized Anxiety Disorder 2-items (GAD-2).
Timepoint [1] 425856 0
Three time points (Immediately before, and during (at week 4-5 and week 12-13) endocrine therapy).
Secondary outcome [2] 427939 0
Joint pain and stiffness will be assessed by the Brief Pain Inventory-Short Form (BPI).
Timepoint [2] 427939 0
Three time points (Immediately before, and during (at week 4-5 and week 12-13) endocrine therapy).
Secondary outcome [3] 427940 0
Estrogen level: Super sensitive estradiol assay will be conducted with blood samples.
Timepoint [3] 427940 0
Three time points (Immediately before, and during (at week 4-5 and week 12-13) endocrine therapy).

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The relationships between the gut microbiome and AEs, QoL, cancer biomarkers and clinical outcomes will be analysed with a linear regression model controlling for sex, age, education level, antibiotic/NSAIDs use, tumour stages, and anti-cancer treatments (surgery, CTX, HT, RT and combined CTX-RT).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/11/2023
Actual
Date of last participant enrolment
Anticipated
31/08/2027
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25432 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 25433 0
Mater Sydney - North Sydney
Recruitment hospital [3] 25434 0
GenesisCare - St Leonards - St Leonards
Recruitment postcode(s) [1] 41174 0
2060 - North Sydney
Recruitment postcode(s) [2] 41173 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 314647 0
Government body
Name [1] 314647 0
Northern Sydney Local Health District- Innovation grant
Country [1] 314647 0
Australia
Funding source category [2] 314650 0
Other Collaborative groups
Name [2] 314650 0
ANZ Breast Cancer Trials Group (ANZ-BCTG)
Country [2] 314650 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Reserve Rd, St Leonards, NSW 2064
Country
Australia
Secondary sponsor category [1] 316612 0
Other Collaborative groups
Name [1] 316612 0
ANZ-BCTG
Address [1] 316612 0
PO Box 283 The Junction, NSW, 2291
Country [1] 316612 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313667 0
Northern Sydney Local Health District Human Research Ethics Office
Ethics committee address [1] 313667 0
Level 13, Kolling Building, 10 Westbourne St, St Leonards NSW 2065
Ethics committee country [1] 313667 0
Australia
Date submitted for ethics approval [1] 313667 0
Approval date [1] 313667 0
30/05/2023
Ethics approval number [1] 313667 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128946 0
A/Prof Byeongsang Oh
Address 128946 0
Northern Sydney Cancer Centre Level 1, ASB, Royal North Shore HospitalSt Leonards, NSW 2065
Country 128946 0
Australia
Phone 128946 0
+61 29465 8164
Fax 128946 0
Email 128946 0
byeongsang.oh@health.nsw.gov.au
Contact person for public queries
Name 128947 0
A/Prof Byeongsang Oh
Address 128947 0
Northern Sydney Cancer Centre Level 1, ASB, Royal North Shore HospitalSt Leonards, NSW 2065
Country 128947 0
Australia
Phone 128947 0
+61 29465 8164
Fax 128947 0
Email 128947 0
byeongsang.oh@health.nsw.gov.au
Contact person for scientific queries
Name 128948 0
A/Prof Byeongsang Oh
Address 128948 0
Northern Sydney Cancer Centre Level 1, ASB, Royal North Shore Hospital, St Leonards, NSW 2065
Country 128948 0
Australia
Phone 128948 0
+61 294631300
Fax 128948 0
Email 128948 0
byeong.oh@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.