Breast CancerEPIONE-01NCT04713917
Evaluation of Innovative Therapeutic Approaches of Vaginal and Sexual Dysfunction After Breast Cancer Treatment
A study testing Hyaluronique Acid Gel, Laser CO2 and Hyaluronique Acid Injection in people with Breast Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Hyaluronique Acid Gel, Laser CO2 and Hyaluronique Acid Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2021to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Henri-Mondor Hospital
Créteil, 94000
YAZID BELKACEMI, 01 49 81 45 22, yazid.belkacemi@aphp.fr
About this study
Official title: Prospective Evaluation of Innovative Therapeutic Approaches of Vaginal and Sexual Dysfunction After Breast Cancer Treatment : a Randomized Multicenter Controlled Trial
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.
Read more
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Hyaluronique Acid Gel, Laser CO2, Hyaluronique Acid Injection
- Keywords
- Locoregional and systemic treatment, Vulvovaginal atrophy, Sexual quality of life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronique Acid GelDevice
Vaginal gel based on HA with liposomal structure applicated 2 times a week
Laser CO2Device
The laser energy delivered along the vaginal wall heats the tissue without damaging it.
Hyaluronique Acid InjectionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Gel Group | Active comparator | Two applications of HA gel (Mucogyne®) per week during one year. Receives: Device: Hyaluronique Acid Gel |
| Laser Group | Experimental | Laser CO2 for vulvovaginal area during 2 sessions (15 min) at visits D0 and M6. Receives: Device: Laser CO2 |
| HA Injection Group | Experimental | Injection of 1 mL of HA at D0 and M6 (DESIRIAL®). Receives: Device: Hyaluronique Acid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of women free from vulvo-vaginal atrophy on the basis of a vaginal health index (VHI) ≥ 15.
Measured: at 12 months
Secondary outcomes (5)
Comparisons among groups of VHI score (absolute and relative changes in the VHI)
Measured: Day 0 to 12 months
Female Sexual Distress (FSD) SCALE
Measured: Day 0 to 12 months
Evaluation of the pain during treatment (Visual Analogue Scale (EVA))
Measured: Day 0 to 12 months
Rate of adverse effects
Measured: Day 0 to 12 months
compliance in the control treatment by the count of forgetfulness during the treatment per topical gel
Measured: Day 0 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start21 Feb 2021
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- INTERmedic, Laboratoires Vivacy, Laboratoires IPRAD PHARMA
- Responsible party
- Sponsor
- Investigators
- Barbara HERSANT, MD, Study director, Assistance Publique - Hôpitaux de ParisYazid BELKACEMI, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713917
- Sponsor's protocol ID
- P170927J
- Other IDs
- 2018-A01678-47
- Acronym
- EPIONE-01
- Status last verified
- Nov 2023
- First submitted
- 15 Jan 2021
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Innovative Therapeutic Approaches of Vaginal and Sexual Dysfunction After Breast Cancer Treatment : a Randomized Multicenter Controlled Trial
- ClinicalTrials.gov ID
- NCT04713917
- Acronym / sponsor ID
- EPIONE-01 / P170927J
- Conditions
- Breast Cancer
- Keywords
- Locoregional and systemic treatment, Vulvovaginal atrophy, Sexual quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- INTERmedic, Laboratoires Vivacy, Laboratoires IPRAD PHARMA
- Study start
- 21 Feb 2021 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Gel Group | Active comparator | Device: Hyaluronique Acid GelTwo applications of HA gel (Mucogyne®) per week during one year. |
| Laser Group | Experimental | Device: Laser CO2Laser CO2 for vulvovaginal area during 2 sessions (15 min) at visits D0 and M6. |
| HA Injection Group | Experimental | Device: Hyaluronique Acid InjectionInjection of 1 mL of HA at D0 and M6 (DESIRIAL®). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronique Acid GelVaginal gel based on HA with liposomal structure applicated 2 times a week | Device | Gel Group |
| Laser CO2The laser energy delivered along the vaginal wall heats the tissue without damaging it. | Device | Laser Group |
| Hyaluronique Acid InjectionHA 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. | Device | HA Injection Group |
Primary outcome
Rate of women free from vulvo-vaginal atrophy on the basis of a vaginal health index (VHI) ≥ 15.
Time frame: at 12 months
5 secondary outcomes
Comparisons among groups of VHI score (absolute and relative changes in the VHI)
Time frame: Day 0 to 12 months
Female Sexual Distress (FSD) SCALE
Time frame: Day 0 to 12 months
Evaluation of the pain during treatment (Visual Analogue Scale (EVA))
Time frame: Day 0 to 12 months
Rate of adverse effects
Time frame: Day 0 to 12 months
compliance in the control treatment by the count of forgetfulness during the treatment per topical gel
Time frame: Day 0 to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara HERSANT, MD study director
Assistance Publique - Hôpitaux de Paris
Yazid BELKACEMI, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronique Acid Gel, Laser CO2 and Hyaluronique Acid Injection in people with Breast Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara HERSANT, MD (1 49 81 45 33 ext. +33, barbara.hersant@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of women free from vulvo-vaginal atrophy on the basis of a vaginal health index (VHI) ≥ 15. (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.