Copaiba Mouthwash with Low-Level Laser Therapy to Prevent Mouth Sores After Stem Cell Transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind phase 2 study compares copaíba mouthwash versus placebo in autologous HSCT patients. Participants will use the assigned mouthwash four times daily and be evaluated daily for oral mucositis, oral pain, and swallowing difficulties. The trial aims to determine if Copaíba can reduce the incidence and severity of mucosal injury associated with high-dose chemotherapy and HSCT. Forty-six participants (23 per group) will be followed through the conditioning and early post-transplant period. The study is conducted at a single Brazilian center and is sponsored by Instituto Nacional de Cancer, Brazil.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Ana Carolina Menezes, PhD' student
• Email: ana.smenezes@gmail.com
• Phone: +55 21 32041859

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.