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

2026년 4월 29일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

관찰

등록 (추정된)

264

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

샘플링 방법

비확률 샘플

연구 인구

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

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Breast cancer patients receiving endocrine therapy
다른: 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
다른: 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)
다른: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Vaginal dryness (NRS)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Sexual Functioning Score
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.

기타 결과 측정

결과 측정
측정값 설명
기간
일반적인 환자, 질병 및 치료 관련 정보
기간: 기준선
일반 및 의료 정보는 내재적 위험 요인(예: 연령 및 흡연력). 질병 및 치료 관련 위험 요소에 대한 정보는 의료 기록(예: 종양 유형 및 병기)을 통해 수집됩니다.
기준선

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Jessa Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 3월 5일

기본 완료 (추정된)

2028년 3월 6일

연구 완료 (추정된)

2028년 8월 31일

연구 등록 날짜

최초 제출

2026년 2월 9일

QC 기준을 충족하는 최초 제출

2026년 4월 29일

처음 게시됨 (실제)

2026년 5월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 4월 29일

마지막으로 확인됨

2026년 2월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2025/205
  • 1S95826N (기타 보조금/기금 번호: Research Foundation - Flanders (FWO))

개별 참가자 데이터(IPD) 계획

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미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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