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

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Questionnaires given before and after photobiomodulation

    Procedure/Surgery

    Questionnaires given at 1 month, 6 months and 12 months

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Questionnaires, scale and scoreExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
From baseline to 1 year

Secondary outcomes

1

Sexual quality of life scores obtained on all dimensions 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.

Time frame
From baseline to 1 year
2

Patient Global Impression of Improvement (PGI-I) score

Evaluation by questionnaire Patient Global Impression of Improvement (PGI-I). The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 to 7. Very much better (1) to Very much worse (7).

Time frame
From baseline to 1 year
3

Determination of the Vaginal Health Index clinical score

The vaginal health index scores five different signs of vaginal health on a one-to-five ranking system. The lower your score, the more unhealthy your vaginal tissue is. The score ranges from 5 (the worst vaginal health) to 25 (the best vaginal health). This scoring system helps doctors to diagnose the severity of genitourinary syndrome of menopause.

Time frame
From baseline to 1 year
4

Determination of symptoms of vulvovaginal atrophy by a visual numerical scale

Visual numerical scale from 0 (no pain and discomfort) to 10 (the most intense pain and discomfort)

Time frame
From baseline to 1 year

Other outcomes

Sponsors and contacts

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