Evaluation of Mucogyne® Ovule in Vulvovaginal Dryness Management in Women Treated by Brachytherapy and/or Radiotherapy for Endometrial or Cervical Cancer.

Study Overview
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Brief Summary
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Randomized, open-label, national (France), multicenter, prospective clinical study, to evaluate the superiority of Mucogyne® ovules over the control group on vaginal health (including hydration) in women treated by brachytherapy and/or radiotherapy for endometrial or cervical cancer.

Official Title
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Evaluation of Mucogyne® Ovule in Vulvovaginal Dryness Management in Women Treated by Brachytherapy and/or Radiotherapy for Endometrial or Cervical Cancer.

Conditions
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Vaginal Disease

Intervention / Treatment
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* Device: Mucogyne® ovule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Woman over 18 hysterectomized patient with endometrial cancer (stage I, stage II and histological type I, without chemotherapy, with brachytherapy and/or radiotherapy) OR patient with cervical cancer (stage IA2 and IB1 with emboli or positive lymphadenopathy and IB2 stages with or without chemotherapy, with brachytherapy and / or radiotherapy) Only for patients with cervical cancer, premenopausal and non-hysterectomized: patient on contraception at least one month before V0 and throughout the study Only for patients with cervical cancer: complete remission Patient capable of receiving and understanding information related to the study, giving informed written consent, and easily completing a quality of life questionnaire Patient affiliated to the French social security system Exclusion Criteria: Patient with clinically observed vulvovaginal infections Patient with endometrial cancer treated with chemotherapy Patient already participating in another study Patient under legal protection, or under guardianship or curatorship Only for patients with cervical cancer: local treatment with estrogen Only for patients with cervical cancer, premenopausal and non-hysterectomized: pregnancy (pregnancy test to be performed at V0)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 80 women with endometrial cancer or Cervical cancer will be recruited over 8 months, 40 being randomized in the Mucogyne® arm, the 40 others in the control arm.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mucogyne®<br>The dosage during the study will be 1 Mucogyne® ovule per day at bedtime for 10 days and then 1 ovule every 2 days until the end of the 3-month follow-up. | Device: Mucogyne® ovule<br>* hyaluronic acid, vaginal ovule<br>|
| No Intervention: Control<br>No treatment for this arm. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal Health Index (VHI) change from inclusion to end of study | Each parameter is evaluated from 1 (worst) to 5 (best/normal): vaginal elasticity, vaginal secretion volume, vaginal pH, epithelial mucous membrane integrity, vaginal hydration/lubrication. The sum of points for each parameter gives the VHI, from 5 (worst) to 25 (best/normal) | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal mucosa scarring evolution | Evolution of scarring of the vaginal mucosa by a composite score: visualization of the hysterectomy scar (not visible / visible) for endometrial cancer patients OR visualization of the cervix (not visible / visible) for cervical cancer patients, presence or absence of vaginal adhesions / cohalescences (walls and bottom of the vagina ), collapse of adhesions to touch (Y / N), edema / redness of vaginal mucosa (indicative of inflammation), pain caused by pressure (Y / N), bleeding caused by contact (none / moderate / severe) | 3 Months | 
| Time to additional local treatment administration |  | 3 Months | 
| Patient Global Impression of Change (PGIC) on vaginal health | Auto-evaluation: score from 1 (very much improved) to 7 (very much worse) on vaginal health related to the study intervention | 3 Months | 
| Symptoms (pain, dyspareunia, vaginal pruritis, vulvovaginal dryness) evolution | Auto-evaluation of the symptoms: pain, dyspareunia, vaginal pruritis, vulvovaginal dryness on Visual Analogic Scale (VAS) of 10mm Patient indicates where she locates the intensity of the symptom from 0mm (no symptom) to 10mm (worst intensity) | 3 Months | 
| VHI change at each visit | Each parameter is evaluated from 1 (worst) to 5 (best/normal): vaginal elasticity, vaginal secretion volume, vaginal pH, epithelial mucous membrane integrity, vaginal hydration/lubrication. The sum of points for each parameters gives the VHI, from 5 (worst) to 25 (best/normal) | 3 Months | 
| Vaginal flora composition (Nugent score) evolution | Measured on vaginal sample collected at inclusion, 1 month and 3 months | 3 Months | 
| Complications and adverse events | Complications and adverse events related to study intervention | 3 Months | 
| Patient satisfaction questionnaire at the end of study | All patients (both arms) will be asked about their satisfaction on the treatment of their vulvogainal symptoms during the study will be assessed using a 5-point Likert scale : At the end of this study, how would you rate your level of satisfaction with the treatment of your vulvovaginal symptoms? Very satisfactory / Satisfactory / Moderate / Poor / Very Poor | 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginal dryness