Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors (V-light cohort)

April 29, 2026 updated by: Jessa Hospital

Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors: a Cohort Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

264

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast cancer patients receiving endocrine therapy
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.
Breast cancer patients receiving chemotherapy
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.
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)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal dryness (NRS)
Time Frame: From enrollment up till 12 months later.
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)
Time Frame: From enrollment up till 12 months later.
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)
Time Frame: From enrollment up till 12 months later.
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)
Time Frame: From enrollment up till 12 months later.
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)
Time Frame: From enrollment up till 12 months later.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual Functioning Score
Time Frame: From enrollment up till 12 months.
The Female Sexual Function Index (FSFI) is a multidimensional, self-reported questionnaire that evaluates the patient's sexual functioning. The questionnaire consists of 19 questions, divided into six subscales (sexual desire, sexual arousal, lubrication, orgasms, sexual gratification and pain during intercourse). The total score ranges from 2 (severely compromised sexual functioning) to 36 (excellent sexual functioning).
From enrollment up till 12 months.
Sexual Distress Score
Time Frame: From enrollment up till 12 months.
The multidimensional, self-reported Female Sexual Distress Scale-Revised 2005 (FSDS-R) questionnaire will be used to evaluate the patient's sexual distress. This questionnaire consists of 13 items scored from 0 (never occurring) to 4 (always occurring). A score of 11 or more effectively discriminates between patients with female sexual distress and patients without distress.
From enrollment up till 12 months.
Quality of Life Score
Time Frame: From enrollment up till 12 months later.
The European Organization for Research and Treatment for Cancer Quality of Life Questionnaires (EORTC QLQ-C30) will be used to assess the patients' quality of life. The EORTC QLQ-C30 consists of 30 questions. These include five functional scales, three symptom scales, a global health status/quality of life (QoL) scale, and six single items. All of the scales and single-item measures range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
From enrollment up till 12 months later.
Quality of Life Score - Breast Cancer Specific
Time Frame: From enrollment up till 12 months later.
The European Organization for Research and Treatment for Cancer Quality of Life Questionnaires (EORTC QLQ-BR42) will be used to assess breast cancer-specific quality of life. The EORTC QLQ-BR42 consists of 42 questions. All of the scales and single item measures range in score from 0 to 100. A high score for the Body Image, Sexual Functioning and Breast Satisfaction scales and for the Future Perspective and Sexual Enjoyment single items represents a high level of functioning, whereas a high score for the Systemic ChemoTherapy Side Effects, Endocrine Symptoms, Arm Symptoms, Breast Symptoms, Hand/foot symptoms/neuropathy, Skeletal Scale and Vaginal Symptoms scales and for the Weight Gain single item represents a high level of symptomatology or problems.
From enrollment up till 12 months later.
Mental Health
Time Frame: From enrollment up till 12 months later.
The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress.
From enrollment up till 12 months later.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
General patient-, disease-, and treatment-related information
Time Frame: Baseline
General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jessa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2026

Primary Completion (Estimated)

March 6, 2028

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

April 29, 2026

First Posted (Actual)

May 4, 2026

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/205
  • 1S95826N (Other Grant/Funding Number: Research Foundation - Flanders (FWO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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