Photobiomodulation for Oral Mucositis and Functional Impairments During Hematopoietic Stem Cell Transplantation
Laser Photobiomodulation to Prevent Oral Mucositis and Functional Impairment Among Adult Hematologic Cancer Patients Undergoing Hematopoietic Stem Cell Transplantation
Universidad del Desarrollo
30 participants
Jun 10, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- Adults over 18 years of age with hematological neoplasms who require medical indication of an HSCT according to the Transplant Committee at Clinica Dávila
- With sufficient understanding of Spanish.
Exclusion Criteria3
- Observed cognitive deficit
- Patients who do not meet the criteria of clinical stability, progression of the disease, and that do not fulfill requirement of the National Hematopoietic Stem Cell Transplantation Program.
- Participants with an oral infection from any type of Candida prior to HSCT.
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Interventions
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.
Usual care for oral mucositis includes education, cryotherapy, and mouth hygiene.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06260111