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Study of a Copaiba-Based Mouthwash Combined With Low-Level Laser Therapy in the Prevention of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation

RecruitingPhase 2Ages 12 Years - anyAllInstituto Nacional de Cancer, Brazil
NCT07810530 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Oral mucositis (OM) one of the most significant acute toxicity of Hematopoietic Stem Cell Transplantation (HSCT). There is already scientific evidence suporting OM the use of: low-level laser therapy (LLLT), cryotherapy (in autologous HSCT when conditioning regimens include high-dose melphalan), and keratinocyte growth factor (in autologous HSCT with high-dose chemotherapy associated with RT). In this sense, an alternative treatment becomes necessary. Based on the preliminary results of the phase I study, a double-blind, randomized phase II study is suggested to evaluate the effectiveness of copaiba-based mouthwash in the prevention of oral mucositis in HSCT was proposed. Patients will be randomized into 2 groups: A (copaíba) and B (placebo) and will use the mouthwash 4x/day. Each group will have 38 patients and be blind to the group in which they are included. They will be evaluated dai

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients aged 12 years or older; * Patients indicated for autologous HSCT; * Patients with intact oral mucosa on the first day of conditioning; * Patients able to understand and adhere to the protocol; * Patients able to perform the oral hygiene protocol; * Patients who, after receiving information and instructions, can provide free and informed consent (ICF) and assent forms. Exclusion Criteria: * Patients currently receiving drugs for treatment and/or prevention of oral mucositis (OM); * Patients who had HSCT indicated but whose procedure was canceled for any reason; * Patients undergoing a second autologous HSCT; * Patients reporting any allergy to copaiba-based compounds.
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What it tests

  • Copaíba
  • Placebo
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Where

1 site
Instituto Nacional de Cancer, Brazil
Rio de Janeiro, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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