Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347926
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-03-28
Brief Title:
Study of Sexual Quality of Life in Women With Breast Cancer Who Had Multidisciplinary Management With Photobiomodulation for Genitourinary Syndrome of the Menopause
Sponsor:
Institut du Cancer de Montpellier - Val dAurelle
Organization:
Institut du Cancer de Montpellier - Val dAurelle
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVABIOSEIN
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
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 58459 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 53 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None