NCT07810530 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
| NCT ID | NCT07810530 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Instituto Nacional de Cancer, Brazil |
| Condition | Oral Mucositis |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2026-03-29 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 76 participants in total. It began in 2026-03-29 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Héliton Spíndola, PhD
STUDY DIRECTOR
Instituto Nacional de Cancer
Frequently Asked Questions
Who can join the NCT07810530 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Oral Mucositis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07810530 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07810530 currently recruiting?
Yes, NCT07810530 is actively recruiting participants. Contact the research team at ana.smenezes@gmail.com for enrollment information.
Where is the NCT07810530 trial being conducted?
This trial is being conducted at Rio de Janeiro, Brazil.
Who is sponsoring the NCT07810530 clinical trial?
NCT07810530 is sponsored by Instituto Nacional de Cancer, Brazil. The principal investigator is Héliton Spíndola, PhD at Instituto Nacional de Cancer. The trial plans to enroll 76 participants.