NCT07563621 Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors
| NCT ID | NCT07563621 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jessa Hospital |
| Condition | Genitourinary Syndrome of Menopause (GSM) |
| Study Type | OBSERVATIONAL |
| Enrollment | 264 participants |
| Start Date | 2026-03-05 |
| Primary Completion | 2028-03-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 264 participants in total. It began in 2026-03-05 with a primary completion date of 2028-03-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07563621 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Genitourinary Syndrome of Menopause (GSM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07563621 currently recruiting?
Yes, NCT07563621 is actively recruiting participants. Contact the research team at jeroen.mebis@jessazh.be for enrollment information.
Where is the NCT07563621 trial being conducted?
This trial is being conducted at Hasselt, Belgium.
Who is sponsoring the NCT07563621 clinical trial?
NCT07563621 is sponsored by Jessa Hospital. The trial plans to enroll 264 participants.