Burden of vaginal and urinary menopause symptoms in breast cancer survivors
Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors: a Cohort Study
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 |
|---|---|
| Enrollment | 264 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Jessa Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hasselt, Limburg) |
| Trial ID | NCT07563621 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hasselt, Limburg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.