HYDRAMUC: Evaluation of Mucogyne® Ovule in Vulvovaginal Dryness Management in Women Treated by Brachytherapy and/or Radiotherapy for Endometrial or Cervical Cancer.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Mucogyne® 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
hyaluronic acid, vaginal ovule
|
| No Intervention: Control No treatment for this arm. |
Outcome Measures
Primary Outcome Measures
- Vaginal Health Index (VHI) change from inclusion to end of study [3 Months]
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)
Secondary Outcome Measures
- Vaginal mucosa scarring evolution [3 Months]
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)
- Time to additional local treatment administration [3 Months]
- Patient Global Impression of Change (PGIC) on vaginal health [3 Months]
Auto-evaluation: score from 1 (very much improved) to 7 (very much worse) on vaginal health related to the study intervention
- Symptoms (pain, dyspareunia, vaginal pruritis, vulvovaginal dryness) evolution [3 Months]
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)
- VHI change at each visit [3 Months]
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)
- Vaginal flora composition (Nugent score) evolution [3 Months]
Measured on vaginal sample collected at inclusion, 1 month and 3 months
- Complications and adverse events [3 Months]
Complications and adverse events related to study intervention
- Patient satisfaction questionnaire at the end of study [3 Months]
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"
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chru Besancon - Site 002 | Besançon | France | 25000 | |
| 2 | Leon Berard - Site 007 | Lyon | France | 69373 | |
| 3 | Institut de Cancerologie de Lorraine - Site 004 | Nancy | France | 54519 | |
| 4 | Chu Nantes - Site 003 | Nantes | France | 44093 | |
| 5 | Chu Caremeau - Site 001 | Nîmes | France | 30029 | |
| 6 | Clinique Pasteur - Site 005 | Toulouse | France | 31076 | |
| 7 | Institut Gustave Roussy - Site 006 | Villejuif | France | 94805 |
Sponsors and Collaborators
- Laboratoires IPRAD
- Créapharm
- Institut Alfred Fournier
- Axonal-Biostatem
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IPR_HYDRAMUC_17