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Clinical Trials/NCT06260111
NCT06260111
Recruiting
Not Applicable

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

Universidad del Desarrollo1 site in 1 country30 target enrollmentStarted: June 10, 2024Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
30
Locations
1
Primary Endpoint
Level of Pain

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
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.

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Level of Pain

Time Frame: 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)

It refers to the perceived level of pain related to oral mucositis from a numeric scale (0 to 10), where 0 means "no pain" and 10 "the worse possible pain". Higher scores means more pain.

Oral Mucositis

Time Frame: 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)

It refers to the maximal degree of oral mucositis developed after stem cell transplantation. It will be recorded daily from the first day after stem cell transplantation up to the day 20 after transplantation). The World Health Organization (WHO) oral mucositis scale will be used. Scores range from 0 (no mucositis), 1 (pain/erythema), 2 (erythema, ulcers; can eat solid foods), 3 (ulceration, requiring only a liquid diet), to 4 (oral feeding is not possible). The higher the grade, the worse the mucositis.

Secondary Outcomes

  • Exercise tolerance(Through study completion on the day of hospital discharge, an average of 1 month)
  • Handgrip strength(Through study completion on the day of hospital discharge, an average of 1 month)
  • Acceptability(Through study completion on the day of hospital discharge, an average of 1 month)
  • Use of opioids(Through study completion on the day of hospital discharge, an average of 1 month)
  • Body mass index(Through study completion on the day of hospital discharge, an average of 1 month)
  • Nutritional status(Through study completion on the day of hospital discharge, an average of 1 month)
  • Arm circumference(Through study completion on the day of hospital discharge, an average of 1 month)
  • Physical fitness(Through study completion on the day of hospital discharge, an average of 1 month)
  • Health related quality of life(Through study completion on the day of hospital discharge, an average of 1 month)
  • Length of hospital stay(Through study completion on the day of hospital discharge, an average of 1 month)
  • Daily calorie intake(Through study completion on the day of hospital discharge, an average of 1 month)
  • Number of days from transplant to engraftment(Through study completion on the day of hospital discharge, an average of 1 month)
  • Triceps skinfold(Through study completion on the day of hospital discharge, an average of 1 month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Cinara Sacomori, Ph.D.

Principal Investigator

Universidad del Desarrollo

Study Sites (1)

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