NCT05308732 — Safety and Tolerability of the Use of Copaiba in Patients With Oral Cancer Submitted to Radiotherapy · CancerIndex
Clinical trial · Interventional
Safety and Tolerability of the Use of Copaiba in Patients With Oral Cancer Submitted to Radiotherapy
Phase I Study of Multiple Ascending Dose, to Investigate the Safety and Tolerability of the Use of Copaiba in Patients With Oral Cancer Submitted to Radiotherapy
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
It will consist of the group of patients who will use copaiba mouthwash. It will be subdivided into 6 consecutive cohorts.
interventionNames
Drug: Copaiba
Primary outcomes (1)
measure
Maximum tolerated dose
timeFrame
Through the use of the copaiba oil, an average of 6 to 7 weeks.
description
Evaluate the maximum tolerated dose of the aqueous copaiba solution.
Secondary outcomes (3)
measure
Acess rate of pain
timeFrame
From baseline to the last day of copaiba use (day 33 to day 37).
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
18 Years
Show eligibility criteria text
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.
References
Publications (51)
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description
Assess the level of pain of the patients during the mouthwash with the aqueous copaiba solution through the visual analog pain scale (classified between 0 to 10, when a higher score means worst level of pain)
measure
Acess rate of oral pain
timeFrame
From baseline to the last day of copaiba use (day 33 to day 37).
description
Assess the level of pain of the patients during the mouthwash with the aqueous copaiba solution through the criteria proposed by the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0.(classified between grades 1 to 3, when a higher score means worst level of pain)
measure
Incidence of Oral Mucositis
timeFrame
From baseline to the last day of copaiba use (day 33 to day 37).
description
Check the incidence of oral mucositis in the treated and untreated areas with low power laser.
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