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

Description

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.

Interventions

• Copaíba (Drug)
  An 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 (Drug)
  Placebo 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.

Eligibility criteria

Conditions

Locations

• Instituto Nacional de Cancer, Brazil — Rio de Janeiro, Rio de Janeiro, Brazil