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RECRUITING
NCT06260111
NA

Photobiomodulation for Oral Mucositis and Functional Impairments During Hematopoietic Stem Cell Transplantation

Sponsor: Universidad del Desarrollo

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to test the efficacy of laser photobiomodulation in adult hematologic cancer patients undergoing hematopoietic stem cell transplantation (HSCT). The main questions it aims to answer are: • Is photobiomodulation with laser in the oral cavity, compared to standard care, effective in preventing oral mucositis and functional impairments in adult patients receiving HSCT? • What is the level of patient´s acceptability of photobiomodulation with laser in the oral cavity during HSCT? Participants once a day will receive photobiomodulation (diode laser device) in their oral cavity from the first day of transplantation conditioning until third day post-transplant. Researchers will compare with usual care to see if photobiomodulation helps preventing oral mucositis and functional impairment.

Official title: Laser Photobiomodulation to Prevent Oral Mucositis and Functional Impairment Among Adult Hematologic Cancer Patients Undergoing Hematopoietic Stem Cell Transplantation

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-06-10

Completion Date

2025-10-30

Last Updated

2024-07-11

Healthy Volunteers

No

Interventions

DEVICE

Photobiomodulation

Photobiomodulation will be used in sessions of approximately 5 to 10 minutes each. An InGaIP diode laser will be used with the following parameters: wavelength of 660 nm, output power of 40 mW, and an energy density of 4 J/cm2 measured at the end of the fiber optic with 0.04 cm2 of section area. The laser will be applied at 10 points in each oral region, with an exposure time of 4 s per point, using 0.16 J of energy per point. The protocol was based on previous studies.

OTHER

Usual care

Usual care for oral mucositis includes education, cryotherapy, and mouth hygiene.

Locations (1)

Clinica Dávila

Santiago, Santiago Metropolitan, Chile