Copaíba-based Mouthwash in Oral Mucotitis Prevention and Treatment in Oral Cancer Patients During Radioteraphy

PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 17, 2025

Primary Completion Date

July 31, 2027

Study Completion Date

February 29, 2028

Conditions
Oral MucositisOral Mucositis (Ulcerative) Due to RadiationOral Mucositis (Ulcerative) Due to Antineoplastic TherapyOral Mucositis Due to Radiation
Interventions
DRUG

Copaíba mouthwash

"A 15% aqueous solution of copaíba (Copaifera Officinalis Resin) manufactured by Interativo Farmácia de Manipulação will be used, under the formula of copaíba oil (Copaifera Officinalis Resin) 15%, liquid mint aroma 5%, tween 80 1%, aqueous solution (Distilled water + Nipagin 0.1%) qsp 100%.~Patients will receive the solution once a week. They will be instructed to shake the bottle before use for homogenization, to use 10mL of the solution for each mouthwash (which should be measured in the 10mL measuring cup that comes with each bottle), 4 times a day, rinsing vigorously for 1 minute and discarding all the solution after use."

DRUG

Placebo mouthwash

"Placebo will be used, under the formula of liquid mint flavor 5%, Nipagim 0.1%, and distilled water qsp 60 ml, packed in packaging compatible with that of the product under investigation, maintaining the same physical characteristics to maintain blinding. The product will be stored at room temperature and stored in the INCA pharmacy.~Patients will receive the solution once a week. They will be instructed to shake the bottle before use for homogenization, to use 10mL of the solution for each mouthwash (which should be measured in the 10mL measuring cup that comes with each bottle), 4 times a day, rinsing vigorously for 1 minute and discarding all the solution after use."

Trial Locations (2)

20231050

RECRUITING

Instituto Nacional de Cancer, Brazil, Rio de Janeiro

NOT_YET_RECRUITING

Instituto Nacional de Cancer, Rio de Janeiro

All Listed Sponsors
lead

Instituto Nacional de Cancer, Brazil

OTHER_GOV