Trial Title:
Study of Sexual Quality of Life in Women With Breast Cancer Who Had Multidisciplinary Management With Photobiomodulation for Genitourinary Syndrome of the Menopause
NCT ID:
NCT06347926
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Sexual troubles
Irritation
Dyspareunia
Vaginal dryness
Photobiomodulation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Questionnaires given before and after photobiomodulation
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Questionnaires given before and after photobiomodulation
Description:
Questionnaires given at 1 month, 6 months and 12 months
Arm group label:
Questionnaires, scale and score
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Cancer in Montpellier
Address:
City:
Montpellier
Zip:
34298
Country:
France
Status:
Recruiting
Contact:
Last name:
Angélique Bobrie, MD
Phone:
467618576
Phone ext:
+33
Email:
angelique.bobrie@icm.unicancer.fr
Investigator:
Last name:
Angélique Bobrie, MD
Email:
Principal Investigator
Start date:
October 10, 2024
Completion date:
August 2025
Lead sponsor:
Agency:
Institut du Cancer de Montpellier - Val d'Aurelle
Agency class:
Other
Source:
Institut du Cancer de Montpellier - Val d'Aurelle
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06347926
