Informations générales (source: ClinicalTrials.gov)
Prospective Evaluation of Innovative Therapeutic Approaches of Vaginal and Sexual Dysfunction After Breast Cancer Treatment : a Randomized Multicenter Controlled Trial
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
février 2021
février 2024
03 décembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:53:39 | Contacter | |||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Henri-Mondor Hospital - 94000 - Créteil - France | YAZID BELKACEMI | 13/12/2025 07:53:39 | Contact (sur clinicalTrials) | ||
Critères
Femme
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
- 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
- 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