Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04713917
Status:
RECRUITING
Last Update Posted:
2023-11-28
First Post:
2021-01-15
Brief Title:
Evaluation of Innovative Therapeutic Approaches of Vaginal and Sexual Dysfunction After Breast Cancer Treatment
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Prospective Evaluation of Innovative Therapeutic Approaches of Vaginal and Sexual Dysfunction After Breast Cancer Treatment a Randomized Multicenter Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-11
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:
EPIONE-01
Brief Summary:
Many studies have shown that locoregional treatment surgery radiotherapy and systemic treatment endocrine therapy and chemotherapy for breast cancer BC may impact sexuality by causing physical andor psychological damages
Approximately 50-75 of BC survivors suffer from vulvovaginal atrophy VVA The earliest symptoms of VVA are decreased vaginal lubrication followed by other vaginal and urinary symptoms such as burning itching bleeding leucorrhoea dyspareunia and dysuria symptoms Various surveys have shown that VVA symptoms lead to female sexual disorder and on their partners through sexual unsatisfactory However it appears that sexuality is a little discussed topic during the follow-up of BC survivors Most of patients relate a poor satisfaction with information and counselling related to sexuality and vaginal health which are denied by many practitioners
Patients treated for BC cannot find relief in hormonal replacement therapy HRT which is considered the gold standard treatment for VVA symptoms The usual treatments for these women are topics such as ovula or gel lubricant hyaluronic acid HA with however a short term effect even when these topics are applied regularly and correctly during at least 2 to 3weeksIn the literature there is a significant impact on VVA at one month but later data are lacking Moreover patients compliance and daily application are paramount of importance for efficacy that could disappear when the treatment is stopped
No randomized controlled trial has compared this treatment to innovative strategies In this context it is important to establish management strategies for VVA and sexual disorder after BC
Our objective is to assess prevalence rate of VVA among breast cancer survivors after the loco regional treatment and chemotherapy and to compare the efficacy of innovative treatments namely new biophysical inductor Laser CO2 and chemical bio inductor Hyaluronic acid injections treatments to the efficacy of standard non-hormonal topic treatment for improving the VVA and the quality of sexual life on a long-term
Approximately 50-75 of BC survivors suffer from vulvovaginal atrophy VVA The earliest symptoms of VVA are decreased vaginal lubrication followed by other vaginal and urinary symptoms such as burning itching bleeding leucorrhoea dyspareunia and dysuria symptoms Various surveys have shown that VVA symptoms lead to female sexual disorder and on their partners through sexual unsatisfactory However it appears that sexuality is a little discussed topic during the follow-up of BC survivors Most of patients relate a poor satisfaction with information and counselling related to sexuality and vaginal health which are denied by many practitioners
Patients treated for BC cannot find relief in hormonal replacement therapy HRT which is considered the gold standard treatment for VVA symptoms The usual treatments for these women are topics such as ovula or gel lubricant hyaluronic acid HA with however a short term effect even when these topics are applied regularly and correctly during at least 2 to 3weeksIn the literature there is a significant impact on VVA at one month but later data are lacking Moreover patients compliance and daily application are paramount of importance for efficacy that could disappear when the treatment is stopped
No randomized controlled trial has compared this treatment to innovative strategies In this context it is important to establish management strategies for VVA and sexual disorder after BC
Our objective is to assess prevalence rate of VVA among breast cancer survivors after the loco regional treatment and chemotherapy and to compare the efficacy of innovative treatments namely new biophysical inductor Laser CO2 and chemical bio inductor Hyaluronic acid injections treatments to the efficacy of standard non-hormonal topic treatment for improving the VVA and the quality of sexual life on a long-term
Detailed Description:
An open-label multicentre controlled trial randomized in 3 parallel groups 111 to assess the one-year superiority of bio physical inductor C02 laser D0 and M6 group laser compared to the standard treatment currently recommended Mucogyne 2 times a week for one year control group in the one hand and of chemical bio inductor Desirial injection of 1 mL of hyaluronic acid in the first 3 cm of the vaginal walls D0 and M6 HA injection group compared to the control group in the other hand in BC survivors with VVA with blinded primary endpoint assessment
The use of these innovative treatments lasers and injections for Vulvovaginal atrophy based on the bio induction and the regenerative medicine could improve the quality of the vaginal mucosa after breast cancer therapy and could be a new strategy for these women who cannot benefit from Hormone Replacement Therapy HRT The benefits expected are the improvement of the quality of vulvo-vaginal mucosa and the improvement of the sexual quality of life of the patient
The use of these innovative treatments lasers and injections for Vulvovaginal atrophy based on the bio induction and the regenerative medicine could improve the quality of the vaginal mucosa after breast cancer therapy and could be a new strategy for these women who cannot benefit from Hormone Replacement Therapy HRT The benefits expected are the improvement of the quality of vulvo-vaginal mucosa and the improvement of the sexual quality of life of the patient
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-A01678-47 | OTHER | N IDRCB | None |