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

NCT07563621 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 264

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

  • Genitourinary Syndrome of Menopause (GSM)
  • Breast Cancer
  • Vulvovaginal Atrophy
  • Genitourinary Syndrome of Menopause

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 cancer patients. This study also seeks to analyze correlations between the extent of GSM, treatment, and patient characteristics.

Sponsors & Collaborators

  • Jessa Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-05
Primary Completion
2028-03-06
Completion
2028-08-31

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07563621 on ClinicalTrials.gov