Clinical trial NCT06347926: Study of Sexual Quality of Life in Women With Breast Cancer Who Had Multidisciplinary Management With Photobiomodulation for Genitourinary Syndrome of the Menopause
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Sexual troubles
Irritation
Dyspareunia
Vaginal dryness
Photobiomodulation
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Questionnaires given before and after photobiomodulation
Primary purpose: OTHER

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.

Detailed description: Breast cancer affects around one in eight women, accounting for 58,459 new cases in 2018 in France. Advances in treatment have improved overall survival, which is currently around 90% at 5 years in industrialized countries. In France, 5.3% of women have survived breast cancer.

However, the disease and its treatment are responsible for 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 the specific problems of the post-cancer period, and care for them has become a major health issue, highlighted in international recommendations and in Cancer Plans since 2003.

Sexual health is a crucial component of well-being and overall quality of life. Sexual quality of life is frequently impaired after cancer treatment. A large-scale survey carried out in France showed that sexual quality of life remained impaired in almost two thirds of patients 2 years and 5 years after cancer diagnosis, all sites combined. An abundance of literature underlines the high frequency of sexuality and intimacy disorders in patients treated for breast cancer, from diagnosis, throughout treatment and into the post-cancer period.

Sexual health is a complex issue, influenced by multiple factors such as education, beliefs, socio-cultural factors, intimacy, relationship with partner, physical and psychological well-being, body image, and personal and gender identity. These multiple factors can be disrupted, modified and altered as a result of cancer diagnosis and treatment. Vaginal dryness and dyspareunia are symptoms frequently found in patients treated for breast cancer, with chemotherapy and hormone therapy as risk factors.

However, the management of sexual disorders remains underdeveloped in France. Three prospective studies have been carried out at the Institute of Cancer in Montpellier (ICM), two of which have been published, analyzing sexual quality of life in patients with non-metastatic breast cancer, and have shown a deterioration in sexual quality of life similar to that described in the literature, with in particular a high frequency of libido disorders, vaginal dryness and altered sexual satisfaction. A low level of communication between patients and healthcare professionals was reported, with a high demand for care expressed by patients. Patients' opinions and suggestions for optimal care were also collected and analyzed. The analysis of these data showed that patients had initiated first-line treatments for vaginal dryness.

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. Light Emitting Diode (LED) PBM has been proposed as an alternative treatment for genitourinary menopausal syndrome. he tissues are exposed to light sources in the visible spectrum, inducing non-thermal, non-cytotoxic biological effects that improve vaginal tissue trophicity. This non-invasive technique has few contraindications (epilepsy, photosensitizing treatment) and no known serious side effects, and has been studied in a number of indications, notably for the treatment of oral mucositis. There are few data on vaginal application, and this technology is being evaluated as part of a clinical trial at the Nimes hospital in patients with GSM in the general population. Interim results based on the inclusion of 130 patients showed clinical improvement in 61 out of 100 patients ("better" or "much better") treated with 6 sessions of PBM, with no serious adverse effects (PhD thesis). There are currently no data specifically on women treated for breast cancer. In the context of setting up an oncosexology care network at the Institute of Cancer in Montpellier.

In line with previous studies of sexual QoL 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 Qaulity of life of patients undergoing treatment for breast cancer and benefiting from this oncosexological support.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. 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.),
2. Patient with psychic or cognitive impairment, or not sufficiently fluent in French to be able to fill in the quality of life questionnaires.

Primary outcomes:
measure: Sexual satisfaction score on one dimension of the SHQ-22 questionnaire
timeFrame: From baseline to 1 year
Secondary outcomes:
measure: Sexual quality of life scores obtained on all dimensions of the SHQ-22 questionnaire
timeFrame: From baseline to 1 year
measure: Patient Global Impression of Improvement (PGI-I) score
timeFrame: From baseline to 1 year
measure: Determination of the Vaginal Health Index clinical score
timeFrame: From baseline to 1 year
measure: Determination of symptoms of vulvovaginal atrophy by a visual numerical scale
timeFrame: From baseline to 1 year
measure: Determination of adverse events by using Common Terminology Criteria for Adverse Events (CTCAE) scale of the National Cancer Institute.
timeFrame: From baseline to 1 year
measure: Number of patients taking other treatments for treating sexual troubles
timeFrame: From baseline to 1 year
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Institute of Cancer in Montpellier
state: Hérault
Study officials:
affiliation: Institute of Cancer in Montpellier
name: Angélique Bobrie, MD
role: STUDY_CHAIR
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