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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
hyaluronic acid, vaginal ovule
Chru Besancon - Site 002
Besançon, France
Leon Berard - Site 007
Lyon, France
Institut de Cancerologie de Lorraine - Site 004
Nancy, France
Chu Nantes - Site 003
Nantes, France
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)
Time frame: 3 Months
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)
Time frame: 3 Months
Time to additional local treatment administration
Time frame: 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
Time frame: 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)
Time frame: 3 Months
VHI change at each visit
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Chu Caremeau - Site 001
Nîmes, France
Clinique Pasteur - Site 005
Toulouse, France
Institut Gustave Roussy - Site 006
Villejuif, France
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)
Time frame: 3 Months
Vaginal flora composition (Nugent score) evolution
Measured on vaginal sample collected at inclusion, 1 month and 3 months
Time frame: 3 Months
Complications and adverse events
Complications and adverse events related to study intervention
Time frame: 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"
Time frame: 3 Months