Genitourinary Syndrome of Menopause (GSM)V-light cohortNCT07563621
Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors
An observational study of Genitourinary Syndrome of Menopause (GSM) and Breast Cancer, run by Jessa Hospital at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Genitourinary Syndrome of Menopause (GSM), Breast Cancer, Vulvovaginal Atrophy
- What is being tested?
- Questionnaires (NRS, DASS-21, EORTC QLQ-C30, EORTC QLQ-BR42, FSFI, FSDS-R)
- How many people
- 264 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Mar 2026to 31 Aug 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Jessa Hospital
Hasselt, Limburg, 3500
Jeroen Mebis, Prof. Dr., +32 11 33 72 21, jeroen.mebis@jessazh.be
Sofie Van Duffel, MSc, +32 11 33 72 31, sofie.vanduffel@uhasselt.be
About this study
Official title: 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.
- Conditions
- Genitourinary Syndrome of Menopause (GSM), Breast Cancer, Vulvovaginal Atrophy, Genitourinary Syndrome of Menopause
- Being tested
- Questionnaires (NRS, DASS-21, EORTC QLQ-C30, EORTC QLQ-BR42, FSFI, FSDS-R)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients receiving endocrine therapy | Not described Receives: Other: Questionnaires (NRS, DASS-21, EORTC QLQ-C30, EORTC QLQ-BR42, FSFI, FSDS-R) | |
| Breast cancer patients receiving chemotherapy | Not described Receives: 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) Receives: Other: Questionnaires (NRS, DASS-21, EORTC QLQ-C30, EORTC QLQ-BR42, FSFI, FSDS-R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: From enrollment up till 12 months later.
Secondary outcomes (5)
Sexual Functioning Score
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).
Measured: From enrollment up till 12 months.
Sexual Distress Score
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.
Measured: From enrollment up till 12 months.
Quality of Life Score
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.
Measured: From enrollment up till 12 months later.
Quality of Life Score - Breast Cancer Specific
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.
Measured: From enrollment up till 12 months later.
Mental Health
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.
Measured: From enrollment up till 12 months later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start5 Mar 2026
- Primary completion6 Mar 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genitourinary Syndrome of Menopause (GSM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 264 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563621
- Sponsor's protocol ID
- 2025/205
- Other IDs
- 1S95826N
- Acronym
- V-light cohort
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors: a Cohort Study
- ClinicalTrials.gov ID
- NCT07563621
- Acronym / sponsor ID
- V-light cohort / 2025/205
- Conditions
- Genitourinary Syndrome of Menopause (GSM), Breast Cancer, Vulvovaginal Atrophy, Genitourinary Syndrome of Menopause
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 6 Mar 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Questionnaires (NRS, DASS-21, EORTC QLQ-C30, EORTC QLQ-BR42, FSFI, FSDS-R)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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Breast cancer patients receiving chemotherapy, Breast cancer patients receiving endocrine therapy, Healthy controls |
Primary outcome
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).
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).
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).
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).
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).
5 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genitourinary Syndrome of Menopause (GSM) and Breast Cancer, run by Jessa Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeroen Mebis, Prof. Dr. (+32 11 33 72 21, jeroen.mebis@jessazh.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal dryness (NRS) (time frame: From enrollment up till 12 months later.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.