Using low-power laser therapy to prevent mouth pain in stem cell transplant patients
Low Power Laser Therapy As Prevention Of Oral Mucositis And Oropharyngeal Pain In Patients Undergoing Allogenetic Hematopoietic Stem Cell Transplantation.
This study is testing if different types of low-power laser therapy can help prevent mouth pain in patients getting stem cell transplants.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Instituto Nacional de Cancer, Brazil Government |
| Drugs / interventions | radiation |
| Locations | 2 sites (Rio de Janeiro, Rio de Janeiro and 1 other locations) |
| Trial ID | NCT06071637 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are scheduled for allogeneic HSCT and have intact oral mucosa.
Not a fit: Patients currently receiving medication for mucositis treatment or those not evaluated by the dental team will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce oral pain and complications for patients undergoing HSCT.
How similar studies have performed: Previous studies have shown promising results with low-level laser therapy in similar contexts, suggesting potential effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rio de Janeiro, Rio de Janeiro and 1 other locations
- Instituto Nacional de Cancer — Rio de Janeiro, Rio de Janeiro, Brazil (Recruiting)
- Instituto Nacional de Cancer — Rio de Janeiro, Brazil (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.