Efficacy of Orosol® in the Treatment of Chemo- and Radiation-induced Mucositis.

NARecruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

November 22, 2022

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Oral Mucositis
Interventions
DEVICE

Topical application of Orosol®

Orosol® is a 20 ml aluminum bottle equipped with a spray without propellant gas for local application. Simply shake the bottle gently, apply the product to the injured surface by pressing your finger on the spray to deliver the product (4 to 5 times so as to form a thin film on the surface of the mouth) . It is recommended to use Orosol® every 2 hours at the start of treatment and then 3 to 4 times a day. The maximum duration of treatment will be 28 days. Eating or drinking should be avoided for the first 15 to 30 minutes after applying the product.

DEVICE

Topical application of Placebo comparator

Placebo comparator is a 20 ml aluminum bottle equipped with a spray without propellant gas for local application. Simply shake the bottle gently, apply the product to the injured surface by pressing your finger on the spray to deliver the product (4 to 5 times so as to form a thin film on the surface of the mouth) . It is recommended to use Placebo comparator every 2 hours at the start of treatment and then 3 to 4 times a day. The maximum duration of treatment will be 28 days. Eating or drinking should be avoided for the first 15 to 30 minutes after applying the product.

Trial Locations (2)

Unknown

NOT_YET_RECRUITING

Centre Jean-Perrin, Clermont-Ferrand

RECRUITING

CHU clermont-ferrand, Clermont-Ferrand

All Listed Sponsors
lead

University Hospital, Clermont-Ferrand

OTHER