Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors

Recruiting now

Conditions studied: Genitourinary Syndrome of Menopause (GSM), Breast Cancer, Vulvovaginal Atrophy, Genitourinary Syndrome of Menopause

In brief

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.

Key facts

Study ID: NCT07563621
Run by: Jessa Hospital
People needed: 264
Starts: 2026-03-05
Expected to finish: 2028-08-31
Last updated by the study team: 2026-05-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Women diagnosed with breast cancer stage 0, I, II, and III
Prior to CT/ET, receiving only one of both (no combination)
Age 18 years or above
Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis)
Dutch-speaking (be able to understand the informed consent and study-related questionnaires)
Signed informed consent

You may not qualify if…

Concomitant CT and ET treatment
Structural restorative therapies, such as photobiomodulation therapy (PBM) and fractional CO₂ laser treatment, are not permitted during the study period. During the study period, only symptomatic treatment of GSM (e.g., vaginal lubricants or moisturizers) will be allowed

Where it is running

Jessa Hospital — Hasselt, Limburg, Belgium (enrolling)

Full record on ClinicalTrials.gov

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