Vaginal Disease
Conditions
Keywords
vaginal dryness
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.
Interventions
DEVICEMucogyne® ovule
hyaluronic acid, vaginal ovule
Sponsors
Créapharm
Institut Alfred Fournier
Axonal-Biostatem
Laboratoires IPRAD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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 |
| 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) |
Countries
France
Outcome results
None listed