Safety and Tolerability of the Use of Copaiba in Patients With Oral Cancer Submitted to Radiotherapy

StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Trial completed Show 4 more changesShow less
    • Study completion date changed from estimate of Dec 2026 to Sep 30, 2026
    • Eligibility criteria expanded, about 13 words
    • Study description expanded, about 8 words
    • Publications: details revised at 48 of 51 entries
  2. Enrollment reduced: 36 → 20 participantsv4
  3. Primary completion date changed from estimate of Dec 2023 to Sep 7, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Apr 2024 to Dec 2026
    • Site details revised
    v3
  4. Primary completion date: Jan 2023 to Dec 2023
    • Study completion date: Apr 2023 to Apr 2024
    • Secondary endpoints: details revised at 3 of 3 entries
    v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05308732
Lead Sponsor Instituto Nacional de Cancer, Brazil
Conditions
(from sponsor)		 Head and Neck Neoplasms, Mucositis Oral, Radiotherapy; Complications
Related terms Head and Neck Neoplasms, Stomatitis
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov