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

NCT06260111 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-07-11

No results posted yet for this study

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.

Conditions

  • Hematologic Cancer

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.

Sponsors & Collaborators

  • Agencia Nacional de Investigación y Desarrollo

    collaborator OTHER

  • Clínica Dávila

    collaborator OTHER

  • Universidad del Desarrollo

    lead OTHER

Principal Investigators

  • Cinara Sacomori, Ph.D. · Universidad del Desarrollo

  • Paulina A Araya-Castro, Ph.D. · Universidad del Desarrollo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-10
Primary Completion
2025-03-30
Completion
2025-10-30

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06260111 on ClinicalTrials.gov