Evaluation of Innovative Therapeutic Approaches of Vaginal and Sexual Dysfunction After Breast Cancer Treatment
NCT ID: NCT04713917
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
330 participants
INTERVENTIONAL
2021-02-21
2024-02-01
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Bio physical inductor : CO2 laser
* Standard treatment : Hyaluronic Acid gel
* Chemical bio inductor : injection of Hyaluronic Acid
TREATMENT
SINGLE
Study Groups
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Gel Group
Two applications of HA gel (Mucogyne®) per week during one year.
Hyaluronique Acid Gel
Vaginal gel based on HA with liposomal structure applicated 2 times a week
Laser Group
Laser CO2 for vulvovaginal area during 2 sessions (15 min) at visits D0 and M6.
Laser CO2
The laser energy delivered along the vaginal wall heats the tissue without damaging it.
HA Injection Group
Injection of 1 mL of HA at D0 and M6 (DESIRIAL®).
Hyaluronique Acid Injection
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.
Interventions
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Hyaluronique Acid Gel
Vaginal gel based on HA with liposomal structure applicated 2 times a week
Laser CO2
The laser energy delivered along the vaginal wall heats the tissue without damaging it.
Hyaluronique Acid Injection
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
FEMALE
No
Sponsors
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INTERmedic
UNKNOWN
Laboratoires Vivacy
INDUSTRY
Laboratoires IPRAD PHARMA
UNKNOWN
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Barbara HERSANT, MD
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Yazid BELKACEMI, MD, PhD
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Locations
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Henri-Mondor Hospital
Créteil, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2018-A01678-47
Identifier Type: OTHER
Identifier Source: secondary_id
P170927J
Identifier Type: -
Identifier Source: org_study_id