Clinical trial NCT06260111: Photobiomodulation for Oral Mucositis and Functional Impairments During Hematopoietic Stem Cell Transplantation
Official title: Laser Photobiomodulation to Prevent Oral Mucositis and Functional Impairment Among Adult Hematologic Cancer Patients Undergoing Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematologic Cancer
Keywords: Low level laser therapy
Hematopoietic stem cell transplantation
Oral mucositis
Physical fitness
Physical therapy
Lead sponsor: Universidad del Desarrollo
Sponsor class: OTHER
Collaborators: name: Agencia Nacional de Investigación y Desarrollo
name: Clínica Dávila
First posted: 2024-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.

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.

Primary outcomes:
measure: Oral Mucositis
timeFrame: From the first day up to the 20th after stem cell transplantation (or up to the day of hospital discharge if prior to day 20)
measure: Level of Pain
timeFrame: From the first day up to the 20th day after stem cell transplantation (or up to the day of hospital discharge if prior to day 20)
Secondary outcomes:
measure: Handgrip strength
timeFrame: Through study completion on the day of hospital discharge, an average of 1 month
measure: Exercise tolerance
timeFrame: Through study completion on the day of hospital discharge, an average of 1 month
measure: Physical fitness
timeFrame: Through study completion on the day of hospital discharge, an average of 1 month
measure: Health related quality of life
timeFrame: Through study completion on the day of hospital discharge, an average of 1 month
measure: Length of hospital stay
timeFrame: Through study completion on the day of hospital discharge, an average of 1 month
measure: Use of opioids
timeFrame: Through study completion on the day of hospital discharge, an average of 1 month
measure: Body mass index
timeFrame: Through study completion on the day of hospital discharge, an average of 1 month
measure: Nutritional status
timeFrame: Through study completion on the day of hospital discharge, an average of 1 month
measure: Daily calorie intake
timeFrame: Through study completion on the day of hospital discharge, an average of 1 month
measure: Arm circumference
timeFrame: Through study completion on the day of hospital discharge, an average of 1 month
measure: Triceps skinfold
timeFrame: Through study completion on the day of hospital discharge, an average of 1 month
measure: Acceptability
timeFrame: Through study completion on the day of hospital discharge, an average of 1 month
measure: Number of days from transplant to engraftment
timeFrame: Through study completion on the day of hospital discharge, an average of 1 month
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Clinica Dávila
state: Metropolitana
Study officials:
affiliation: Universidad del Desarrollo
name: Cinara Sacomori, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad del Desarrollo
name: Paulina A Araya-Castro, Ph.D.
role: STUDY_CHAIR
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