Burden of vaginal and urinary menopause symptoms in breast cancer survivors
Official title: Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors: a Cohort Study
Run by Jessa Hospital · NCT07563621 · Data updated 2026-11-12
This study will see how common and how severe genitourinary menopause symptoms are in breast cancer survivors receiving single-mode cancer treatment compared with controls.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 264 (estimated) |
| Sponsor | Jessa Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hasselt, Limburg) |
| Status | Recruiting |
| Started | March 5, 2026 |
| Main results expected | March 6, 2028 |
| Study ends | August 31, 2028 |
| Registry record updated | May 4, 2026 |
| Trial ID | NCT07563621 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women age 18 or older with stage 0–III breast cancer who are Dutch-speaking, able to consent, and receiving only one mode of treatment (either chemotherapy or endocrine therapy alone) are ideal candidates.
✕Probably not a fit
Women receiving concurrent chemotherapy and endocrine therapy, those undergoing structural restorative GSM therapies during the study, or non-Dutch speakers are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, controlled cohort study at Jessa Hospital that enrolls women with stage 0–III breast cancer who are receiving either chemotherapy or endocrine therapy alone. Participants complete validated questionnaires (NRS, DASS-21, EORTC QLQ-C30, EORTC QLQ-BR42, FSFI, FSDS-R) to document vaginal and urinary symptoms, sexual function, and quality of life. Structural restorative therapies (like fractional CO₂ laser or photobiomodulation) are excluded during the study, though symptomatic use of lubricants or moisturizers is permitted. Results will be compared with a control group to better define the prevalence and severity of GSM in this population.
Why it matters
Potential benefit: If successful, the study will clarify how common and severe GSM is in breast cancer survivors and guide clinicians to better target symptom management.
How similar studies have gone: A recent systematic review by some investigators highlighted GSM as a significant problem but noted most prior studies lacked control groups, so similar approaches have identified the issue but with limited controlled evidence.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Jessa Hospital
Hasselt, Limburg, Belgium Recruiting
Study contacts
- Study coordinator: Jeroen Mebis, Prof. Dr.
- Email: jeroen.mebis@jessazh.be
- Phone: +32 11 33 72 21
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.