Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

29. April 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

264

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Breast cancer patients receiving endocrine therapy
Sonstiges: 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
Sonstiges: 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)
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Vaginal dryness (NRS)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sexual Functioning Score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Allgemeine patienten-, krankheits- und behandlungsbezogene Informationen
Zeitfenster: Grundlinie
Allgemeine und medizinische Informationen werden durch einen kurzen Patientenfragebogen gesammelt, um intrinsische Risikofaktoren (z. Alter und Rauchergeschichte). Informationen zu den krankheits- und behandlungsbezogenen Risikofaktoren werden über Krankenakten erhoben (z. B. Tumortyp und -stadium).
Grundlinie

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Jessa Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

5. März 2026

Primärer Abschluss (Geschätzt)

6. März 2028

Studienabschluss (Geschätzt)

31. August 2028

Studienanmeldedaten

Zuerst eingereicht

9. Februar 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. April 2026

Zuerst gepostet (Tatsächlich)

4. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. April 2026

Zuletzt verifiziert

1. Februar 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2025/205
  • 1S95826N (Andere Zuschuss-/Finanzierungsnummer: Research Foundation - Flanders (FWO))

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren