Evaluation of Innovative Therapeutic Approaches of Vaginal and Sexual Dysfunction After Breast Cancer Treatment

NCT04713917 | Unknown

• 2 other identifiers: P170927J2018-A01678-47
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Locoregional and systemic treatment; Vulvovaginal atrophy; Sexual quality of life

Outcome Measures

Primary Outcomes (1)

• Rate of women free from vulvo-vaginal atrophy on the basis of a vaginal health index (VHI) ≥ 15.

  at 12 months

Secondary Outcomes (5)

• Comparisons among groups of VHI score (absolute and relative changes in the VHI)

  Day 0 to 12 months

• Female Sexual Distress (FSD) SCALE

  Day 0 to 12 months

• Evaluation of the pain during treatment (Visual Analogue Scale (EVA))

  Day 0 to 12 months

• Rate of adverse effects

  Day 0 to 12 months

• compliance in the control treatment by the count of forgetfulness during the treatment per topical gel

  Day 0 to 12 months

Study Arms (3)

Gel Group

ACTIVE COMPARATOR

Two applications of HA gel (Mucogyne®) per week during one year.

Device: Hyaluronique Acid Gel

Laser Group

EXPERIMENTAL

Laser CO2 for vulvovaginal area during 2 sessions (15 min) at visits D0 and M6.

Device: Laser CO2

HA Injection Group

EXPERIMENTAL

Injection of 1 mL of HA at D0 and M6 (DESIRIAL®).

Device: Hyaluronique Acid Injection

Interventions

Hyaluronique Acid Gel DEVICE

Vaginal gel based on HA with liposomal structure applicated 2 times a week

Gel Group

Laser CO2 DEVICE

The laser energy delivered along the vaginal wall heats the tissue without damaging it.

Laser Group

Hyaluronique Acid Injection DEVICE

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.

HA Injection Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who present VVA with a vaginal health index \< 15
• 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

You may not qualify if:

• 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.
• History of vulvo vaginal cancer
• History of Papilloma virus
• History of vaginal herpes
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• INTERmedic: collaborator
• Laboratoires Vivacy: collaborator
• Laboratoires IPRAD PHARMA: collaborator

Study Sites (1)

Henri-Mondor Hospital

Créteil, 94000, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Lasers, Gas

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Barbara HERSANT, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Yazid BELKACEMI, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Barbara HERSANT, MD

CONTACT

1 49 81 45 33; barbara.hersant@aphp.fr

Yazid BELKACEMI, MD, PhD

CONTACT

1 49 81 45 22; yazid.belkacemi@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: According to the center's organization, an operator and an investigator-evaluator will be identified for each patient or for all patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 19, 2021
• Study Start: February 21, 2021
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

FR (1)