Status:
ACTIVE_NOT_RECRUITING
Safety and Tolerability of the Use of Copaiba in Patients With Oral Cancer Submitted to Radiotherapy
Lead Sponsor:
Instituto Nacional de Cancer, Brazil
Conditions:
Head and Neck Neoplasms
Mucositis Oral
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 n...
Detailed Description
This is a phase I study, carried out in a single institution to assess the safety and tolerability of using the aqueous copaiba solution for mouthwash in 03 to 36 patients diagnosed with cancer in the...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05308732
Start Date
May 11 2021
End Date
December 1 2026
Last Update
January 8 2026
Active Locations (1)
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1
Instituto Nacional de Cancer
Rio de Janeiro, Rio de Janeiro, Brazil, 20231-050