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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
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Scientific title
The Gut Microbiome and Vasomotor Symptoms in Women with Estrogen Receptor-Positive Breast Cancer undergoing Endocrine Therapy
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Secondary ID [1]
310441
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None
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Universal Trial Number (UTN)
None
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Trial acronym
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Linked study record
None
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Health condition
Health condition(s) or problem(s) studied:
Breast cancer
331224
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Hot flushes
331790
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Anxiety
331791
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Join pain and stiffness
331792
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Condition category
Condition code
Cancer
328528
328528
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0
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Breast
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
326842
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Prevention
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Intervention code [2]
326843
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Treatment: Drugs
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Gut microbiome profile assessed using shotgun metagenomic gene
sequencing of stool samples
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Assessment method [1]
335838
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Timepoint [1]
335838
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Three time points (Immediately before, and during (at week 4-5 and week 12-13) endocrine therapy).
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Primary outcome [2]
335839
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Hot flushes will be assessed by the Hot Flushes Activity and Severity (HFAS) questionnaire.
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Assessment method [2]
335839
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Timepoint [2]
335839
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Three time points Immediately before, and during (at week 4-5 and week 12-13) endocrine therapy).
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Secondary outcome [1]
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- Anxiety will be assessed by the Generalized Anxiety Disorder 2-items (GAD-2).
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Assessment method [1]
425856
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Timepoint [1]
425856
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Three time points (Immediately before, and during (at week 4-5 and week 12-13) endocrine therapy).
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Secondary outcome [2]
427939
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Joint pain and stiffness will be assessed by the Brief Pain Inventory-Short Form (BPI).
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Assessment method [2]
427939
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Timepoint [2]
427939
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Three time points (Immediately before, and during (at week 4-5 and week 12-13) endocrine therapy).
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Secondary outcome [3]
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Estrogen level: Super sensitive estradiol assay will be conducted with blood samples.
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Assessment method [3]
427940
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Timepoint [3]
427940
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Three time points (Immediately before, and during (at week 4-5 and week 12-13) endocrine therapy).
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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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)).
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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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).
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
7/11/2023
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Actual
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Date of last participant enrolment
Anticipated
31/08/2027
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Actual
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Date of last data collection
Anticipated
31/12/2027
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
25432
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [2]
25433
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Mater Sydney - North Sydney
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Recruitment hospital [3]
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GenesisCare - St Leonards - St Leonards
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Recruitment postcode(s) [1]
41173
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2065 - St Leonards
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Recruitment postcode(s) [2]
41174
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2060 - North Sydney
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Funding & Sponsors
Funding source category [1]
314647
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Government body
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Name [1]
314647
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Northern Sydney Local Health District- Innovation grant
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Address [1]
314647
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Northern Sydney Cancer Centre Level 1 ASB, Radiation Oncology Royal North Shore Hospital St Leonards NSW 2065
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Country [1]
314647
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Australia
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Funding source category [2]
314650
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Other Collaborative groups
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Name [2]
314650
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ANZ Breast Cancer Trials Group (ANZ-BCTG)
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Address [2]
314650
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PO Box 283 The Junction, NSW, 2291
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Country [2]
314650
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Australia
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Primary sponsor type
Hospital
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Name
Royal North Shore Hospital
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Address
Reserve Rd, St Leonards, NSW 2064
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Country
Australia
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Secondary sponsor category [1]
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Other Collaborative groups
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Name [1]
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ANZ-BCTG
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Address [1]
316612
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PO Box 283 The Junction, NSW, 2291
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Country [1]
316612
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313667
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Northern Sydney Local Health District Human Research Ethics Office
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Ethics committee address [1]
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Level 13, Kolling Building, 10 Westbourne St, St Leonards NSW 2065
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Ethics committee country [1]
313667
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Australia
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Date submitted for ethics approval [1]
313667
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Approval date [1]
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30/05/2023
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Ethics approval number [1]
313667
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Byeongsang Oh
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Address
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Northern Sydney Cancer Centre Level 1, ASB, Royal North Shore HospitalSt Leonards, NSW 2065
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Country
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Australia
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Phone
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+61 29465 8164
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Fax
128946
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Email
128946
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[email protected]
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Contact person for public queries
Name
128947
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A/Prof Byeongsang Oh
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Address
128947
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Northern Sydney Cancer Centre Level 1, ASB, Royal North Shore HospitalSt Leonards, NSW 2065
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Country
128947
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Australia
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Phone
128947
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+61 29465 8164
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Fax
128947
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Email
128947
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[email protected]
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Contact person for scientific queries
Name
128948
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A/Prof Byeongsang Oh
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Address
128948
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Northern Sydney Cancer Centre Level 1, ASB, Royal North Shore Hospital, St Leonards, NSW 2065
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Country
128948
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Australia
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Phone
128948
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+61 294631300
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Fax
128948
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Email
128948
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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