Status:
RECRUITING
Low Power Laser Therapy As Prevention Of Oral Mucositis And Oropharyngeal Pain In Patients Undergoing Allogenetic HSCT
Lead Sponsor:
Instituto Nacional de Cancer, Brazil
Conditions:
Hematopoietic Stem Cell Transplantation
Low-Level Light Therapy
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief Summary
Objective: To compare the effects of two low-power laser therapy protocols (application of a wavelength in the mouth, red region and another in the neck infrared region X simultaneous dual application...
Detailed Description
This is a phase III, double-blind, randomized study that will use low-power laser to prevent oral mucositis and oropharyngeal pain in two protocols with different dosimetry (divided into Group A and G...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06071637
Start Date
August 1 2023
End Date
February 28 2027
Last Update
October 6 2023
Active Locations (2)
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1
Instituto Nacional de Cancer
Rio de Janeiro, Rio de Janeiro, Brazil, 20231-050
2
Instituto Nacional de Cancer
Rio de Janeiro, Brazil, 20231-050