Innovative treatments for vaginal and sexual dysfunction after breast cancer
Prospective Evaluation of Innovative Therapeutic Approaches of Vaginal and Sexual Dysfunction After Breast Cancer Treatment : a Randomized Multicenter Controlled Trial
This study is testing new treatments like laser therapy and injections to see if they can help women with vaginal and sexual problems after breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Créteil) |
| Trial ID | NCT04713917 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of innovative therapeutic approaches, including CO2 laser treatment and hyaluronic acid injections, for women experiencing vulvovaginal atrophy (VVA) following breast cancer treatment. The study is designed as an open-label, multicenter, controlled trial with three parallel groups to compare these new treatments against standard care. Participants will be assessed over one year to determine improvements in vaginal health and sexual quality of life. The trial aims to address the often-overlooked issue of sexual health in breast cancer survivors.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 75 who have non-metastatic breast cancer and are experiencing VVA symptoms.
Not a fit: Patients who are pregnant, breastfeeding, or have a history of vulvovaginal cancer or infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the sexual quality of life and vaginal health for breast cancer survivors suffering from VVA.
How similar studies have performed: Other studies have shown promising results with similar innovative approaches for treating VVA, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Créteil
- Henri-Mondor Hospital — Créteil, France (Recruiting)
Study contacts
- Study coordinator: Barbara HERSANT, MD
- Email: barbara.hersant@aphp.fr
- Phone: 1 49 81 45 33
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.