Safety and Tolerability of the Use of Copaiba in Patients With Oral Cancer Submitted to Radiotherapy

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to propose an alternative and auxiliary methodology for the prevention and treatment of Oral Mucositis (OM) in patients undergoing radiotherapy or radio and chemotherapy for head and neck neoplasms through the use of copaiba-based mouthwash, since the treatment that currently has proven efficacy for the prevention of OM(Low Power Laser Therapy) cannot be applied in tumor regions due to the risk of stimulating the tissue proliferation of malignant cells.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Cancer, Brazil

Criteria

Inclusion Criteria:

• Age ≥ 18 years old.

• Patients enrolled at INCA with a diagnosis of cell carcinoma squamous, adenoid cystic carcinoma, mucoepidermoid carcinoma, carcinoma of acinar cells, low-grade polymorph adenocarcinoma, located in the oral cavity (ICD-10 C00 to C06); located in the oral cavity with the indication of exclusive radiotherapy (by IMRT/VMAT technique) or radiotherapy (by IMRT/ VMAT) associated with chemotherapy.

• Performance status (PS) 0 or 1.

• Patients with intact oral mucosa (except the tumor area) without color change and volume on the first day of treatment.

• Patients able to cooperate with treatment.

• Patients capable of performing the oral hygiene protocol.

• Patients who after the information and instructions signed the term of free and informed consent of the patient in accordance with Resolution 466/12 of the National Health Council.

Exclusion Criteria:

• Patients who are receiving drugs for the treatment and/or prevention of oral mucositis.

• Patients undergoing radiotherapy with planning that excludes the oral cavity of the treatment field.

• Patients undergoing palliative radiotherapy.

• Patients with cervical lymph node metastasis greater than 6cm (N3).

• Patients who report any type of allergy to copaiba-based compounds.

• Patients diagnosed with oral lichen planus.