Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnaires (NRS, DASS-21, EORTC QLQ-C30, EORTC QLQ-BR42, FSFI, FSDS-R).
- Who it may be relevant to
- Registry conditions: Genitourinary Syndrome of Menopause (GSM), Breast Cancer, Vulvovaginal Atrophy, Genitourinary Syndrome of Menopause. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors: a Cohort Study
Overview
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.
Interventions
- Other Questionnaires (NRS, DASS-21, EORTC QLQ-C30, EORTC QLQ-BR42, FSFI, FSDS-R)
Primary objective: The study seeks primarily to provide a comprehensive overview of the burden of GSM in breast cancer patients receiving endocrine therapy (ET) or chemotherapy (CT) in comparison to a healthy control group. Secondary objective: The secondary aim of this study is to evaluate the extent of GSM-related symptoms in breast cancer patients and compare CT and ET. Furthermore, this study aims to evaluate the effect of GSM on the QoL, sexual health, and mental well-being of breast cance
Primary outcome measures
- Vaginal dryness (NRS) [Time frame: From enrollment up till 12 months later.]
- Vaginal pruritus (NRS) [Time frame: From enrollment up till 12 months later.]
- Vaginal discharge (NRS) [Time frame: From enrollment up till 12 months later.]
- Vaginal hemorrhage (NRS) [Time frame: From enrollment up till 12 months later.]
- Vaginal burning sensation (NRS) [Time frame: From enrollment up till 12 months later.]
Secondary outcome measures (5)
- Sexual Functioning Score [Time frame: From enrollment up till 12 months.]
- Sexual Distress Score [Time frame: From enrollment up till 12 months.]
- Quality of Life Score [Time frame: From enrollment up till 12 months later.]
- Quality of Life Score - Breast Cancer Specific [Time frame: From enrollment up till 12 months later.]
- Mental Health [Time frame: From enrollment up till 12 months later.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- Jessa Hospital — Hasselt
Identifiers
NCT: NCT07563621 · 2025/205 · 1S95826N