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
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Maximum tolerated dose
Study Overview
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 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.
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 oral cavity.
In the selection/baseline period, the investigator or professional designated by him will assign a unique number to the patient being evaluated to participate in the study.
The investigator or professional designated by him may register the patient as soon as the eligibility for participation is confirmed and he signs the free and informed consent form. The patients included in the study will receive instructions on oral hygiene and the aqueous copaiba solution for mouthwash.
The recruitment and design of the study will be carried out according to the "3 + 3" design (modified Fibonacci design) with the planned inclusion of 6 successive cohorts (of 3 patients) with different patients. Each cohort of patients will be closely monitored for one week before moving on to a new cohort. There will be no dose escalation in the same patient. The concentration of the aqueous copaiba solution and the frequency of the mouthwash will be considered dose.
Patients will be treated according to the dose levels listed below, from the first day of radiation therapy:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Copaiba arm
It will consist of the group of patients who will use copaiba mouthwash. It will be subdivided into 6 consecutive cohorts.
Intervention: Copaiba (Drug)
Outcomes
Primary Outcomes
Maximum tolerated dose
Time Frame: Through the use of the copaiba oil, an average of 6 to 7 weeks.
Evaluate the maximum tolerated dose of the aqueous copaiba solution.
Secondary Outcomes
- Acess rate of pain(From baseline to the last day of copaiba use (day 33 to day 37).)
- Acess rate of oral pain(From baseline to the last day of copaiba use (day 33 to day 37).)
- Incidence of Oral Mucositis(From baseline to the last day of copaiba use (day 33 to day 37).)