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 daily by a dental surgeon about oral mucositis, pain in the oral cavity and oropharynx, and dysphagia and will undergo daily laser therapy sessions, until neutropenic recovery.
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 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.
Parallel
Copaíba
DrugAn aqueous solution of copaíba (Copaifera Officinalis Resin) at 15% concentration will be used, manufactured by Interativo Pharmacy, according to the formula: copaíba oil (Copaifera Officinalis Resin) 15%, liquid mint aroma 5%, Tween 80 1%, aqueous solution (distilled water + Nipagin 0.1%) q.s.p. 100%. The product will be stored at room temperature and kept in the pharmacy of INCA. Patients will receive the solution once a week. They will be instructed to shake the bottle before use to homogenize the solution. They should use 10 mL of the solution per mouthwash (measured with the 10 mL dosing cup provided with each bottle), 4 times daily, performing vigorous mouthwashes for 1 minute and then spitting out all the solution after use. Swallowing the mouthwash is not recommended.
Placebo
DrugPlacebo will be used, formulated as: liquid mint aroma 5%, Nipagin 0.1%, and distilled water q.s.p. 60 mL, packaged in a container identical to the investigational product to maintain physical characteristics and blinding. The product will be stored at room temperature and kept in the INCA pharmacy. Patients will receive the solution once a week. They will be instructed to shake the bottle before use to homogenize the solution. They should use 10 mL per mouthwash (measured with the 10 mL dosing cup provided), 4 times daily, performing vigorous mouthwashes for 1 minute and then spitting out all the solution after use. Patients will be instructed not to swallow the mouthwash.
Safety and efficacy evaluation through adverse event related to the use of the product (Common Terminology Criteria for Adverse Events v5.0 and the Visual Analogic Scale)
Evaluate the safety and efficacy of Copaiba mouthwash combined with LLLT in patients undergoing autologous Hematopoietic Stem Cell Transplantation by evaluating the occurrence of an adverse event related to the use of the product under investigation (pain 4 degrees above the Visual Analogic Scale score previously reported by the patient, nausea or vomiting for 7 consecutive days exclusively associated with the times of use of the mouthwash) The Common Terminology Criteria for Adverse Events v5.0 ranks the events from 1 to 5, with higher scores meaning worse outcome. The Visual Analogic Scale score ranks the eventos from 0 to 10, with higher scores meaning worse outcome.
OM (World Health Organization scale)
Compare the incidence of the maximum grade of oral mucositis between the two groups. The World Health organization scale is used for mucositis assessment and ranks the lesions from 1 to 4, with higher scores meaning worse outcome.
OM ulcerated area (Sonis scale)
Compare the average ulcerated area between the two groups according to the Sonis scale. The Sonis scale is used for mucositis assessment and ranks the ulcers from 0 to 2 and the erithema from 0 to 1, with higher scores meaning worse outcome.
OM erythema area (Sonis scale)
Compare the average erythema area between the two groups according to the Sonis scale. The Sonis scale is used for mucositis assessment and ranks the ulcers from 0 to 2 and the erithema from 0 to 1, with higher scores meaning worse outcome.
OM (Sonis scale)
Compare the average sum of ulcerated and erythema areas between the two groups according to the Sonis scale. The Sonis scale is used for mucositis assessment and ranks the ulcers from 0 to 2 and the erithema from 0 to 1, with higher scores meaning worse outcome.
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