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

NCT07563621 | Recruiting DMC

• 2 other identifiers: 2025/2051S95826N
• Study Type: observational
• Target: 264
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (5)

• Vaginal dryness (NRS)

  The Numeric Rating Scale (NRS) will be used to evaluate GSM-related vaginal dryness. The NRS is an 11-point scale ranging from 0 (none) to 10 (maximum severity).

  From enrollment up till 12 months later.

• Vaginal pruritus (NRS)

  Description: The Numeric Rating Scale (NRS) will be used to evaluate GSM-related vaginal pruritus. The NRS is an 11-point scale ranging from 0 (none) to 10 (maximum severity).

  From enrollment up till 12 months later.

• Vaginal discharge (NRS)

  The Numeric Rating Scale (NRS) will be used to evaluate GSM-related vaginal discharge. The NRS is an 11-point scale ranging from 0 (none) to 10 (maximum severity).

  From enrollment up till 12 months later.

• Vaginal hemorrhage (NRS)

  The Numeric Rating Scale (NRS) will be used to evaluate GSM-related vaginal hemorrhage. The NRS is an 11-point scale ranging from 0 (none) to 10 (maximum severity).

  From enrollment up till 12 months later.

• Vaginal burning sensation (NRS)

  The Numeric Rating Scale (NRS) will be used to evaluate GSM-related vaginal burning sensation. The NRS is an 11-point scale ranging from 0 (none) to 10 (maximum severity).

  From enrollment up till 12 months later.

Secondary Outcomes (5)

• Sexual Functioning Score

  From enrollment up till 12 months.

• Sexual Distress Score

  From enrollment up till 12 months.

• Quality of Life Score

  From enrollment up till 12 months later.

• Quality of Life Score - Breast Cancer Specific

  From enrollment up till 12 months later.

• Mental Health

  From enrollment up till 12 months later.

Other Outcomes (1)

• General patient-, disease-, and treatment-related information

  Baseline

Study Arms (3)

Breast cancer patients receiving endocrine therapy

Other: Questionnaires (NRS, DASS-21, EORTC QLQ-C30, EORTC QLQ-BR42, FSFI, FSDS-R)

Breast cancer patients receiving chemotherapy

Other: Questionnaires (NRS, DASS-21, EORTC QLQ-C30, EORTC QLQ-BR42, FSFI, FSDS-R)

Healthy controls

The control group includes healthy biological women who are matched with the included breast cancer patients. Factors for matching include: Age; BMI; Menopausal status (for breast cancer patients: prior to treatment)

Other: Questionnaires (NRS, DASS-21, EORTC QLQ-C30, EORTC QLQ-BR42, FSFI, FSDS-R)

Interventions

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

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.

Breast cancer patients receiving chemotherapy; Breast cancer patients receiving endocrine therapy; Healthy controls

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study will only include biologically female patients, as the study populations consist of breast cancer patients experiencing Genitourinary Syndrome of Menopause (GSM). The biologically male breast cancer patients are not appropriate for this study, related to menopause.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients through the Oncology department of Jessa Hospital (Hasselt) Healthy control through the Gynecology department of Jessa Hospital (Hasselt) or flyers

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Jeroen Mebis, Prof. Dr.

CONTACT

+32 11 33 72 21; jeroen.mebis@jessazh.be

Sofie Van Duffel, MSc

CONTACT

+32 11 33 72 31; sofie.vanduffel@uhasselt.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: May 4, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): March 6, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-02

Locations

BE (1)