Evaluation of Innovative Therapeutic Approaches of Vaginal and Sexual Dysfunction After Breast Cancer Treatment (EPIONE-01)
Primary Purpose
Breast Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hyaluronique Acid Gel
Laser CO2
Hyaluronique Acid Injection
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Locoregional and systemic treatment, Vulvovaginal atrophy, Sexual quality of life
Eligibility Criteria
Inclusion Criteria:
- Women who present VVA with a vaginal health index < 15
- 18 years ≤ Age ≤ 75 years
- Patient with non-metastatic breast cancer
- End of loco-regional treatments (surgery+/- radiotherapy) and chemotherapy for 6 months
- Patients with no psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Written consent
- Affiliation to a social security system
Exclusion Criteria:
- Pregnant or breastfeeding woman (A Urinary bHCG will be performed for no menopausal women)
- Vulvo vaginal area showing signs of clinical inflammation and/or viral infection (e.g.: Papilloma, Herpes), bacterial, fungal.
- Abnormal vaginal smear within 3 years before inclusion
- History of vulvo vaginal cancer
- History of Papilloma virus
- History of vaginal herpes
- Use of topical hyaluronic acid application in the month before inclusion
- History of allergy to HA
- Hypersensitivity to the components of Mucogyne®, and Desirial®
- Patients with tendency to develop hypertrophic scars
- No contraception, or no efficient contraception(for women with non-menopausal status)
- Patients under legal protection
- Prisoners
- Participation to another interventional study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Gel Group
Laser Group
HA Injection Group
Arm Description
Two applications of HA gel (Mucogyne®) per week during one year.
Laser CO2 for vulvovaginal area during 2 sessions (15 min) at visits D0 and M6.
Injection of 1 mL of HA at D0 and M6 (DESIRIAL®).
Outcomes
Primary Outcome Measures
Rate of women free from vulvo-vaginal atrophy on the basis of a vaginal health index (VHI) ≥ 15.
Secondary Outcome Measures
Comparisons among groups of VHI score (absolute and relative changes in the VHI)
Female Sexual Distress (FSD) SCALE
Evaluation of the pain during treatment (Visual Analogue Scale (EVA))
Rate of adverse effects
compliance in the control treatment by the count of forgetfulness during the treatment per topical gel
Full Information
NCT ID
NCT04713917
First Posted
January 15, 2021
Last Updated
January 15, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
INTERmedic, Laboratoires Vivacy, Laboratoires IPRAD PHARMA
1. Study Identification
Unique Protocol Identification Number
NCT04713917
Brief Title
Evaluation of Innovative Therapeutic Approaches of Vaginal and Sexual Dysfunction After Breast Cancer Treatment
Acronym
EPIONE-01
Official Title
Prospective Evaluation of Innovative Therapeutic Approaches of Vaginal and Sexual Dysfunction After Breast Cancer Treatment : a Randomized Multicenter Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2021 (Anticipated)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
INTERmedic, Laboratoires Vivacy, Laboratoires IPRAD PHARMA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 and/or 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 3/weeks.In 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 (1:1:1) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Locoregional and systemic treatment, Vulvovaginal atrophy, Sexual quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
An open-label multicentre controlled trial randomized in 3 parallel groups (1:1:1) :
Bio physical inductor : CO2 laser
Standard treatment : Hyaluronic Acid gel
Chemical bio inductor : injection of Hyaluronic Acid
Masking
Outcomes Assessor
Masking Description
According to the center's organization, an operator and an investigator-evaluator will be identified for each patient or for all patients.
Allocation
Randomized
Enrollment
330 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gel Group
Arm Type
Active Comparator
Arm Description
Two applications of HA gel (Mucogyne®) per week during one year.
Arm Title
Laser Group
Arm Type
Experimental
Arm Description
Laser CO2 for vulvovaginal area during 2 sessions (15 min) at visits D0 and M6.
Arm Title
HA Injection Group
Arm Type
Experimental
Arm Description
Injection of 1 mL of HA at D0 and M6 (DESIRIAL®).
Intervention Type
Device
Intervention Name(s)
Hyaluronique Acid Gel
Intervention Description
Vaginal gel based on HA with liposomal structure applicated 2 times a week
Intervention Type
Device
Intervention Name(s)
Laser CO2
Intervention Description
The laser energy delivered along the vaginal wall heats the tissue without damaging it.
Intervention Type
Device
Intervention Name(s)
Hyaluronique Acid Injection
Intervention Description
HA injection performed under the mucosae (2-3mm in depth) following one injection point every 5mm on the 3 first cm of the vagina and on the posterior part of the introitus.
Primary Outcome Measure Information:
Title
Rate of women free from vulvo-vaginal atrophy on the basis of a vaginal health index (VHI) ≥ 15.
Time Frame
at 12 months
Secondary Outcome Measure Information:
Title
Comparisons among groups of VHI score (absolute and relative changes in the VHI)
Time Frame
Day 0 to 12 months
Title
Female Sexual Distress (FSD) SCALE
Time Frame
Day 0 to 12 months
Title
Evaluation of the pain during treatment (Visual Analogue Scale (EVA))
Time Frame
Day 0 to 12 months
Title
Rate of adverse effects
Time Frame
Day 0 to 12 months
Title
compliance in the control treatment by the count of forgetfulness during the treatment per topical gel
Time Frame
Day 0 to 12 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women who present VVA with a vaginal health index < 15
18 years ≤ Age ≤ 75 years
Patient with non-metastatic breast cancer
End of loco-regional treatments (surgery+/- radiotherapy) and chemotherapy for 6 months
Patients with no psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Written consent
Affiliation to a social security system
Exclusion Criteria:
Pregnant or breastfeeding woman (A Urinary bHCG will be performed for no menopausal women)
Vulvo vaginal area showing signs of clinical inflammation and/or viral infection (e.g.: Papilloma, Herpes), bacterial, fungal.
Abnormal vaginal smear within 3 years before inclusion
History of vulvo vaginal cancer
History of Papilloma virus
History of vaginal herpes
Use of topical hyaluronic acid application in the month before inclusion
History of allergy to HA
Hypersensitivity to the components of Mucogyne®, and Desirial®
Patients with tendency to develop hypertrophic scars
No contraception, or no efficient contraception(for women with non-menopausal status)
Patients under legal protection
Prisoners
Participation to another interventional study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara HERSANT, MD
Phone
1 49 81 45 33
Ext
+33
Email
barbara.hersant@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Yazid BELKACEMI, MD, PhD
Phone
1 49 81 45 22
Ext
+33
Email
yazid.belkacemi@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara HERSANT, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yazid BELKACEMI, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Innovative Therapeutic Approaches of Vaginal and Sexual Dysfunction After Breast Cancer Treatment
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