Phase II Study to Evaluate the Effectiviness of copaíba-based Mouthwash in Oral Mucotitis Prevention and Treatment in Oral Cancer Patients During Radioteraphy

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Oral mucositis is the most significant acute toxicity of oral cavity radiotherapy. The available scientific evidence supports its preventive and therapeutic approach with low-level laser; however, this is unsuitable for tumor regions due to the risk of stimulating cellular metabolism. In this sense, an alternative treatment becomes necessary. Based on the preliminary results of the phase I study, a double-blind, randomized phase II study is suggested to evaluate the effectiveness of copaiba-based mouthwash in the prevention of oral mucositis in patients undergoing radiotherapy for oral cavity tumors. Patients will be randomized into 2 groups: A (copaíba) and B (placebo) and will use the mouthwash 4x/day. Each group will have 20 patients and be blind to the group in which they are included. They will be evaluated daily by a dental surgeon about oral mucositis, pain in the oral cavity and oropharynx, and dysphagia and will undergo daily laser therapy sessions, until the end of radiotherapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients aged 18 years or older;

• Patients enrolled at INCA diagnosed with malignant neoplasms located in the oral cavity or oropharynx with an extension of the lesion to the oral cavity (IDC-10 C01 to C06 or IDC10); with the indication of exclusive RT (using the Intensity Modulated Radiotherapy (IMRT)/ Volumetric Modulated Arcotherapy (VMAT) technique) or combined with surgery and/or CT;

• Patients with expected RT doses between 50 and 70Gy;

• Patients capable of understanding and adhering to the protocol;

• Patients capable of performing the oral hygiene protocol;

• Patients who, after the information and instructions, can provide the free and informed consent form.

Locations
Other Locations
Brazil
Instituto Nacional de Cancer
NOT_YET_RECRUITING
Rio De Janeiro
Instituto Nacional de Cancer, Brazil
RECRUITING
Rio De Janeiro
Contact Information
Primary
Héliton Antunes
hspindola@inca.gov.br
55 21 32076597
Backup
Ana Carolina Menezes
ana.smenezes@gmail.com
55 21 988745766
Time Frame
Start Date: 2025-01-17
Estimated Completion Date: 2028-02
Participants
Target number of participants: 40
Treatments
Experimental: Copaíba
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Instituto Nacional de Cancer, Brazil

This content was sourced from clinicaltrials.gov