Actively Recruiting
Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors: a Cohort Study
Led by Jessa Hospital · Updated on 2026-05-04
264
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on breast cancer survivors who often experience menopause-related symptoms, especially Genitourinary Syndrome of Menopause (GSM), while undergoing endocrine therapy or chemotherapy. GSM is caused by lower estrogen levels, leading to vaginal and urinary symptoms like dryness, irritation, pain during intercourse, infections, and urinary urgency. The study aims to better understand how common and severe these symptoms are in breast cancer patients by comparing those on hormone therapy or chemotherapy with healthy women. The study involves three groups: breast cancer patients receiving endocrine therapy, those receiving chemotherapy, and healthy women without breast cancer as a control group. Participants complete questionnaires about GSM symptoms and related health aspects. Healthy controls fill out the questionnaires once, while breast cancer patients do so multiple times during treatment and follow-up. This design allows the researchers to see how symptoms change over time and differ by treatment type. Participants will be involved for up to 12 months, completing questionnaires that measure vaginal symptoms such as dryness, itching, discharge, bleeding, and burning sensations. Secondary measures include sexual functioning, sexual distress, quality of life, and mental health. The study carefully tracks symptom changes and their impact on wellbeing to understand the burden of GSM in breast cancer survivors.
CONDITIONS
Brief Title
Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women diagnosed with breast cancer stage 0, I, II, or III
- Receiving only chemotherapy or only endocrine therapy, not both combined
- Age 18 years or older
- No documented or observable psychiatric or neurological disorders interfering with participation
- Able to understand Dutch and complete study questionnaires
- Signed informed consent
You will not qualify if you...
- Receiving both chemotherapy and endocrine therapy at the same time
- Use of structural restorative therapies like photobiomodulation therapy or fractional CO2 laser treatment during study period
- Only symptomatic treatment of GSM such as vaginal lubricants or moisturizers allowed during study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants complete questionnaires to assess symptoms related to genitourinary syndrome of menopause and quality of life over time.
Regular questionnaire assessments from enrollment up to 12 months
Trial Site Locations
Total: 1 location
1
Jessa Hospital
Hasselt, Limburg, Belgium, 3500
Actively Recruiting
Research Team
J
Jeroen Mebis, Prof. Dr.
S
Sofie Van Duffel, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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