Status:
UNKNOWN
Evaluation of Innovative Therapeutic Approaches of Vaginal and Sexual Dysfunction After Breast Cancer Treatment
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
INTERmedic
Laboratoires Vivacy
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
NA
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 ...
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 stand...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT04713917
Start Date
February 21 2021
End Date
February 1 2024
Last Update
November 28 2023
Active Locations (1)
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1
Henri-Mondor Hospital
Créteil, France, 94000