Actively Recruiting
Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors
Led by Jessa Hospital · Updated on 2026-05-04
264
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Breast cancer survivors (BCS) often face unique challenges during and after treatment, including the onset of menopause-related symptoms. Genitourinary Syndrome of Menopause (GSM) is a common concern in BCS undergoing endocrine therapy (ET). It is a chronic condition caused by estrogen deficiency, leading to vaginal and urinary symptoms such as dryness, irritation, pain during intercourse, recurrent infections, and urinary urgency. The prevalence of GSM in BCS varies widely depending on factors such as the type of ET, individual patient characteristics, and the duration of treatment. As such, the prevalence of GSM in BCS can range from 13% to 95.2%. A recent systematic review performed by part of the investigators of this study concludes that GSM is a significant problem for breast cancer patients. However, most studies lack a control group, limiting the results' validity. Therefore, this study aims to determine the extent of the GSM burden in BCS using a prospective, controlled cohort study. This study will compare breast cancer patients receiving endocrine therapy (ET) with those undergoing chemotherapy (CT), as CT may also induce GSM-like symptoms. In addition, a comparison will be made with healthy controls. For this study, two groups of participants are included: women with breast cancer and a healthy control group without breast cancer. Within the breast cancer group, a distinction is made between women receiving chemotherapy only and women undergoing hormone therapy only. All participants complete questionnaires. The control group completes these questionnaires once, whereas women with breast cancer are asked to complete the same questionnaires at multiple time points during their treatment and follow-up. This longitudinal approach allows us to assess how potential symptoms evolve over the course of treatment. By comparing responses between both groups, a clearer understanding of which symptoms occur more frequently in women with breast cancer as a consequence of their treatment can be obtained.
CONDITIONS
Official 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, and III
- Receiving only chemotherapy or endocrine therapy (not both) prior to treatment
- Age 18 years or above
- No documented or observable psychiatric or neurological disorders that might interfere 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 simultaneously
- Use of structural restorative therapies such as photobiomodulation therapy or fractional CO2 laser treatment during the study
- Only symptomatic treatment for GSM (e.g., vaginal lubricants or moisturizers) allowed during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jessa Hospital
Hasselt, Limburg, Belgium, 3500
Actively Recruiting
Research Team
J
Jeroen Mebis, Prof. Dr.
CONTACT
S
Sofie Van Duffel, MSc
CONTACT
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here