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

Recruitingn/aAges 18 Years - anyFemaleJessa Hospital
NCT07563621 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, th

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📋 Eligibility rules (as published)
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
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What it tests

  • Questionnaires (NRS, DASS-21, EORTC QLQ-C30, EORTC QLQ-BR42, FSFI, FSDS-R)
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Where

1 site
Jessa Hospital
Hasselt, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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