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Evaluation of Innovative Therapeutic Approaches of Vaginal and Sexual Dysfunction After Breast Cancer Treatment (EPIONE-01)

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ClinicalTrials.gov Identifier: NCT04713917
Recruitment Status : Not yet recruiting
First Posted : January 19, 2021
Last Update Posted : January 19, 2021
Sponsor:
Collaborators:
INTERmedic
Laboratoires Vivacy
Laboratoires IPRAD PHARMA
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.


Condition or disease Intervention/treatment Phase
Breast Cancer Device: Hyaluronique Acid Gel Device: Laser CO2 Device: Hyaluronique Acid Injection Not Applicable

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 standard treatment currently recommended (Mucogyne, 2 times a week for one year, control group) in the one hand, and of chemical bio inductor (Desirial, injection of 1 mL of hyaluronic acid in the first 3 cm of the vaginal walls, D0 and M6, HA injection group) compared to the control group in the other hand in BC survivors with VVA, with blinded primary endpoint assessment.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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
Masking: Single (Outcomes Assessor)
Masking Description: According to the center's organization, an operator and an investigator-evaluator will be identified for each patient or for all patients.
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Innovative Therapeutic Approaches of Vaginal and Sexual Dysfunction After Breast Cancer Treatment : a Randomized Multicenter Controlled Trial
Estimated Study Start Date : February 1, 2021
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : February 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Gel Group
Two applications of HA gel (Mucogyne®) per week during one year.
 Device: Hyaluronique Acid Gel
Vaginal gel based on HA with liposomal structure applicated 2 times a week
Experimental: Laser Group
Laser CO2 for vulvovaginal area during 2 sessions (15 min) at visits D0 and M6.
 Device: Laser CO2
The laser energy delivered along the vaginal wall heats the tissue without damaging it.
Experimental: HA Injection Group
Injection of 1 mL of HA at D0 and M6 (DESIRIAL®).
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of women free from vulvo-vaginal atrophy on the basis of a vaginal health index (VHI) ≥ 15. [ Time Frame: at 12 months ]

Secondary Outcome Measures :
  1. Comparisons among groups of VHI score (absolute and relative changes in the VHI) [ Time Frame: Day 0 to 12 months ]
  2. Female Sexual Distress (FSD) SCALE [ Time Frame: Day 0 to 12 months ]
  3. Evaluation of the pain during treatment (Visual Analogue Scale (EVA)) [ Time Frame: Day 0 to 12 months ]
  4. Rate of adverse effects [ Time Frame: Day 0 to 12 months ]
  5. compliance in the control treatment by the count of forgetfulness during the treatment per topical gel [ Time Frame: Day 0 to 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04713917


Contacts
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Contact: Barbara HERSANT, MD 1 49 81 45 33 ext +33 barbara.hersant@aphp.fr
Contact: Yazid BELKACEMI, MD, PhD 1 49 81 45 22 ext +33 yazid.belkacemi@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
INTERmedic
Laboratoires Vivacy
Laboratoires IPRAD PHARMA
Investigators
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Principal Investigator: Barbara HERSANT, MD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Yazid BELKACEMI, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04713917    
Other Study ID Numbers: P170927J
2018-A01678-47 ( Other Identifier: N° IDRCB )
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Locoregional and systemic treatment
Vulvovaginal atrophy
Sexual quality of life
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases