Clinical trial NCT04664985: Evaluation of Mucogyne® Ovule in Vulvovaginal Dryness Management in Women Treated by Brachytherapy and/or Radiotherapy for Endometrial or Cervical Cancer.
Official title: Evaluation of Mucogyne® Ovule in Vulvovaginal Dryness Management in Women Treated by Brachytherapy and/or Radiotherapy for Endometrial or Cervical Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginal Disease
Keywords: vaginal dryness
Lead sponsor: Laboratoires IPRAD
Sponsor class: INDUSTRY
Collaborators: name: Créapharm
name: Institut Alfred Fournier
name: Axonal-Biostatem
First posted: 2020-12-11
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Vaginal Health Index (VHI) change from inclusion to end of study
timeFrame: 3 Months
Secondary outcomes:
measure: Vaginal mucosa scarring evolution
timeFrame: 3 Months
measure: Time to additional local treatment administration
timeFrame: 3 Months
measure: Patient Global Impression of Change (PGIC) on vaginal health
timeFrame: 3 Months
measure: Symptoms (pain, dyspareunia, vaginal pruritis, vulvovaginal dryness) evolution
timeFrame: 3 Months
measure: VHI change at each visit
timeFrame: 3 Months
measure: Vaginal flora composition (Nugent score) evolution
timeFrame: 3 Months
measure: Complications and adverse events
timeFrame: 3 Months
measure: Patient satisfaction questionnaire at the end of study
timeFrame: 3 Months
Other outcomes:
Locations:
city: Besançon
country: France
facility: Chru Besancon - Site 002
city: Lyon
country: France
facility: Leon Berard - Site 007
city: Nancy
country: France
facility: Institut de Cancerologie de Lorraine - Site 004
city: Nantes
country: France
facility: Chu Nantes - Site 003
city: Nîmes
country: France
facility: Chu Caremeau - Site 001
city: Toulouse
country: France
facility: Clinique Pasteur - Site 005
city: Villejuif
country: France
facility: Institut Gustave Roussy - Site 006
Study officials:
References: