Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-24 @ 9:47 PM
NCT ID:
NCT05308732
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05308732
Study Brief:
Protocol Section:
NCT05308732