Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06347926

Study of Sexual Quality of Life in Women With Breast Cancer Who Had Multidisciplinary Management With Photobiomodulation for Genitourinary Syndrome of the Menopause

Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2025-11-18

25

Participants Needed

1

Research Sites

141 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The treatment of breast cancer as well as the disease are responsible for genito-urinary symptoms that can persist over time and impair quality of life. Given the improved prognosis of breast cancer, more and more patients are confronted with specific post-cancer issues, and the care has become a major health challenge. Sexual health is a crucial component of well-being and overall quality of life. Vaginal dryness and dyspareunia are symptoms frequently found in patients treated for breast cancer, with chemotherapy and hormone therapy as risk factors. However, the treatment of sexual disorders remains underdeveloped in France. Vaginal dryness is part of a broader syndrome known as genitourinary syndrome of menopause (GSM), or vulvovaginal atrophy, which may combine vulvovaginal (dryness, irritation, burning), sexual (dyspareunia) and urinary (infections, pollakiuria, urgency) symptoms secondary to hypoestrogenemia, exacerbated by breast cancer treatments. Since hormonal treatments are contraindicated, the first-line treatment for GSM in patients treated for breast cancer is the application of non-hormonal trophic treatments (regular vaginal moisturizers, lubricants during intercourse). However, these treatments are often insufficient to provide effective relief. There is therefore growing interest in the development of second-line treatments for GSM : intra-vaginal hyaluronic acid injections, laser, photobiomodulation (PBM), etc. PBM using Light Emitting Diodes (LED) has been proposed as an alternative treatment for genitourinary syndrome of the menopause. The tissues are exposed to light sources in the visible spectrum, inducing non-thermal, non-cytotoxic biological effects that improve vaginal tissue trophicity. In line with previous studies of sexual quality of life carried out at the center, and in the context of the recent establishment of our multidisciplinary network for the 2nd-line treatment of genitourinary menopausal syndrome with Photobiomodulation, we would like to carry out a descriptive study of the sexual QoL of patients undergoing treatment for breast cancer and benefiting from this oncosexological support.

CONDITIONS

Official Title

Study of Sexual Quality of Life in Women With Breast Cancer Who Had Multidisciplinary Management With Photobiomodulation for Genitourinary Syndrome of the Menopause

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Woman aged 18 years or older
  • Diagnosed with breast cancer at any stage or tumor biology
  • Experiencing persistent menopausal genitourinary symptoms after at least 3 months of local vaginal moisturizer treatment
  • Eligible for photobiomodulation as a second-line treatment for menopausal genitourinary syndrome during routine care
Not Eligible

You will not qualify if you...

  • Already receiving or have received second-line treatment for menopausal genitourinary symptoms such as photobiomodulation, laser, or intra-vaginal hyaluronic acid injections
  • Having cognitive or psychiatric impairments, or insufficient fluency in French to complete quality of life questionnaires

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Institute of Cancer in Montpellier

Montpellier, Hérault, France, 34298

Actively Recruiting

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Research Team

A

Angélique Bobrie, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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