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

NCT06347926 | Recruiting

• 1 other identifier: PROICM 2023-11 EVA
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Keywords

Sexual troubles; Irritation; Dyspareunia; Vaginal dryness; Photobiomodulation

Outcome Measures

Primary Outcomes (1)

• Sexual satisfaction score on one dimension of the SHQ-22 questionnaire

  Evaluation by sexual health questionnaire (SHQ-22). The SHQ-22 questionnaire is a multidimensional quality of life instrument used to measure sexual health in patients with cancer (men or women). This new tool covers both sexual functioning and psychosexual components. It includes 8 items on sexual satisfaction, 3 items on sexual pain, and 11 single items in an integrative approach, leading to 7 functional scales and 4 symptom scales. In these questionnaires, higher scores in the functioning scales indicate a better functional level, whereas higher scores in the symptom scales indicate the severity of problems.

  From baseline to 1 year

Secondary Outcomes (6)

• Sexual quality of life scores obtained on all dimensions of the SHQ-22 questionnaire

  From baseline to 1 year

• Patient Global Impression of Improvement (PGI-I) score

  From baseline to 1 year

• Determination of the Vaginal Health Index clinical score

  From baseline to 1 year

• Determination of symptoms of vulvovaginal atrophy by a visual numerical scale

  From baseline to 1 year

• Determination of adverse events by using Common Terminology Criteria for Adverse Events (CTCAE) scale of the National Cancer Institute.

  From baseline to 1 year

Study Arms (1)

Questionnaires, scale and score

EXPERIMENTAL

Questionnaires, numeric visual scale and clinical score

Procedure: Questionnaires given before and after photobiomodulation

Interventions

Questionnaires given before and after photobiomodulation PROCEDURE

Questionnaires given at 1 month, 6 months and 12 months

Questionnaires, scale and score

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Woman ≥ 18,
• Diagnosis of breast cancer regardless of tumor biology or stage (localized or metastatic),
• Patient with persistent menopause genito-urinary symptoms after a minimum of 3 months of local treatment with vaginal moisturizers,
• Patient eligible for photobiomodulation as 2nd-line treatment for menopausal genitourinary syndrome as part of routine care.

You may not qualify if:

• Patient who have already undergone or are undergoing a 2nd-line treatment for menopause genito-urinary symptoms (photobiomodulation, laser, intra-vaginal injection of hyaluronic acid, etc.),
• Patient with psychic or cognitive impairment, or not sufficiently fluent in French to be able to fill in the quality of life questionnaires.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Institute of Cancer in Montpellier

Montpellier, Hérault, 34298, France

RECRUITING

Related Publications (14)

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MeSH Terms

Conditions

Breast Neoplasms; Dyspareunia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Angélique Bobrie, MD

  Institute of Cancer in Montpellier

  STUDY CHAIR

Central Study Contacts

Angélique Bobrie, MD

CONTACT

467618576; angelique.bobrie@icm.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Questionnaires given before and after photobiomodulation

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 4, 2024
• Study Start: March 13, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Access to study data upon written detailed request sent to the institute of Montpellier Cancer (ICM), following publication and until 5 years after publication of summary data.
• Access Criteria: The data shared will be limited to that required for independent mandated verification of the published results, the applicant will need authorization from ICM for personal access, and data will only be transferred after signing of a data access agreement.

Locations

FR (1)