Using low-power laser therapy to prevent mouth pain in stem cell transplant patients

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 phase III, double-blind, randomized study aims to compare two protocols of low-power laser therapy to prevent oral mucositis and oropharyngeal pain in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Patients will be divided into two groups, each receiving different dosimetry of laser treatment, and will be evaluated for pain, dysphagia, and the need for total parenteral nutrition and opioids. The study will take place at the Bone Marrow Transplant Center of the Instituto Nacional de Cancer in Brazil, with strict eligibility criteria to ensure patient safety and cooperation. Randomization will be conducted using the REDCap® program to maintain the integrity of the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with indication for allogeneic HSCT;
* Patients over 18 years old;
* Patients with intact oral mucosa on the first day of conditioning (D-7);
* Patients able to cooperate with treatment;
* Patients capable of performing the oral hygiene protocol;
* Patients who agreed to participate in the study through the informed consent form (TCLE) in accordance with Resolution 466/12 of the National Health Council.

Exclusion Criteria:

* Patients who are receiving medication for the treatment and/or prevention of mucositis;
* Patients who were not previously evaluated and released by INCA's Dentistry section team

Where it's running

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

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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.