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

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

NCT ID: NCT06260111

Condition: Hematologic Cancer

Conditions: Official terms:
Hematologic Neoplasms
Mucositis
Stomatitis

Conditions: Keywords:
Low level laser therapy
Hematopoietic stem cell transplantation
Oral mucositis
Physical fitness
Physical therapy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: The design of the study consists of a randomized, controlled trial with parallel groups (photobiomodulation + usual care versus a control group with only usual care), allocation ratio of 1:1.

Primary purpose: Prevention

Masking: Double (Investigator, Outcomes Assessor)

Masking description: Assessor will be blinded only for the secondary outcomes. The person responsible for statistical analyses will also be blinded.

Intervention:

Intervention type: Device
Intervention name: Photobiomodulation
Description: 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.
Arm group label: Photobiomodulation group

Other name: Low level laser therapy

Intervention type: Other
Intervention name: Usual care
Description: Usual care for oral mucositis includes education, cryotherapy, and mouth hygiene.
Arm group label: Control group
Arm group label: Photobiomodulation group

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.

Detailed description: Background: Oral mucositis is a highly prevalent condition in individuals treated for hematologic neoplasms, primarily during hematopoietic stem cell transplantation (HSCT). This condition delays the recovery process, increasing infections, interventions, and hospital stays. To date, there are few experimental trials evaluating the use of photobiomodulation with laser for the management of oral mucositis and reporting its effect on functional outcomes in patients with hematologic cancer undergoing HSCT. Aim: To evaluate the effectiveness and social acceptability of using photobiomodulation in the oral cavity to prevent mucositis and functional impairments in adult patients undergoing HSCT. Methods: Randomized controlled clinical trial with parallel groups (intervention group with photobiomodulation versus a control group), assessor and statistician blinded. Participants and setting: 30 patients with hematologic neoplasms aged 18 to 65 undergoing HSCT at the Oncology and Bone Marrow Transplant Unit of Clínica Dávila. Primary outcome measures: Oral mucositis will be assessed on a daily basis with the World Health Organization Scale. Functional capacity will be evaluated with a 2-minute static walking test; handgrip strength using digital Jamar® dynamometry; lower limb strength with 30s Sits-and-Stand test; and quality of life using the Functional Assessment of Cancer Therapy Bone Marrow Transplant questionnaire. Acceptability will be assessed by recording treatment adherence and a Visual Analog Scale. Evaluations will be performed at two time points: on admission to the transplant unit before the start of the conditioning regimen and on the day of hospital discharge. Intervention: Photobiomodulation will be delivered from the first day of conditioning until day 3 post-transplant. A diode laser device with a wavelength of 660 nm, an output power of 40 mW, and an energy density of 4 J/cm2 measured at the end of the optical fiber with 0.04 cm2 of sectional area will be used. The investigators expect that photobiomodulation prevents oral mucositis and enhance functional capacity, muscle strength, nutritional status, and quality of life in patients with hematologic cancer undergoing bone marrow transplantation.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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 Criteria: - 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.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: Clinica Dávila

Address:
City: Santiago
Zip: 8431657
Country: Chile

Status: Recruiting

Contact:
Last name: Tomás A López-Espinoza, MSc.C.

Phone: +56962056755
Email: tlopeze@udd.cl

Contact backup:
Last name: Hernán López, MD

Phone: +56966795985
Email: hernan.lopez@davila.cl

Investigator:
Last name: Monica Peña, Nurse
Email: Sub-Investigator

Start date: June 10, 2024

Completion date: October 30, 2025

Lead sponsor:
Agency: Universidad del Desarrollo
Agency class: Other

Collaborator:
Agency: Agencia Nacional de Investigación y Desarrollo
Agency class: Other

Collaborator:
Agency: Clínica Dávila
Agency class: Other

Source: Universidad del Desarrollo

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06260111
https://www.ncbi.nlm.nih.gov/mesh/