Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06260111

Laser Photobiomodulation to Prevent Oral Mucositis and Functional Impairment in Adults With Hematologic Cancer Undergoing Stem Cell Transplantation

Led by Universidad del Desarrollo · Updated on 2024-07-11

30

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

Sponsors

U

Universidad del Desarrollo

Lead Sponsor

A

Agencia Nacional de Investigación y Desarrollo

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of laser photobiomodulation to prevent oral mucositis and functional impairments in adults with hematologic cancer undergoing hematopoietic stem cell transplantation (HSCT). The study aims to compare the effectiveness and patient acceptability of photobiomodulation in the oral cavity against standard care. This randomized controlled trial includes adults aged 18 to 65 years with hematological neoplasms who require HSCT. Participants will be randomly assigned to receive either photobiomodulation plus usual care or usual care alone. Photobiomodulation involves daily sessions using a diode laser device with specific parameters, applied to multiple points inside the mouth from the first day of conditioning until three days after transplant. Usual care includes education, cryotherapy, and mouth hygiene. The intervention group receives laser treatment sessions lasting about 5 to 10 minutes each. During the study, researchers will monitor oral mucositis daily up to 20 days after transplant or until hospital discharge. They will also assess pain levels, handgrip strength, exercise tolerance, physical fitness, quality of life, nutritional status, and other health measures through the hospital stay, averaging about one month. Patient adherence and acceptability of the laser treatment will be recorded. Evaluations occur at admission before conditioning and at discharge to understand the laser's impact and patient experience.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults over 18 years of age with hematologic neoplasms who require hematopoietic stem cell transplantation
  • Sufficient understanding of Spanish
Not Eligible

You will not qualify if you...

  • Observed cognitive deficit
  • Not clinically stable or disease progression not meeting national transplant program requirements
  • Oral infection from any type of Candida prior to transplantation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From the first day of conditioning until day 3 post-transplant

Participants receive photobiomodulation sessions in the oral cavity from the first day of conditioning until 3 days after stem cell transplantation to prevent oral mucositis and functional impairments. Usual care including education, cryotherapy, and mouth hygiene is provided to all participants.

Daily visits during treatment

Follow-up

Duration - Up to 20 days post-transplant or until hospital discharge, approximately 1 month total

Participants are monitored for oral mucositis, pain, functional capacity, muscle strength, nutritional status, quality of life, and other health outcomes until hospital discharge, approximately 1 month after transplant.

Assessments on admission to transplant unit and at hospital discharge with daily monitoring during hospital stay

Trial Site Locations

Total: 1 location

1

Clinica Dávila

Santiago, Santiago Metropolitan, Chile, 8431657

Actively Recruiting

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Research Team

C

Cinara Sacomori, Ph.D.

T

Tomás Lopez, MScC.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Low-level laser therapy prevents severe oral mucositis in patients submitted to hematopoietic stem cell transplantation: a randomized clinical trial.

Betânia Ferreira, Fabiana Moura da Motta Silveira, Flávia Augusta de Orange

https://pubmed.ncbi.nlm.nih.gov/26248655

Handgrip Strength Values Depend on Tumor Entity and Predict 180-Day Mortality in Malnourished Cancer Patients.

Pascal Tribolet, Nina Kaegi-Braun, Carla Gressies...

https://pubmed.ncbi.nlm.nih.gov/35631314

Quality of life measurement in bone marrow transplantation: development of the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) scale.

R P McQuellon, G B Russell, D F Cella...

https://pubmed.ncbi.nlm.nih.gov/9051246

Development and validation of criterion-referenced clinically relevant fitness standards for maintaining physical independence in later years.

Roberta E Rikli, C Jessie Jones

https://pubmed.ncbi.nlm.nih.gov/22613940

Photobiomodulation therapy to prevent oral mucositis and functional impairment in adult patients with haematological cancer undergoing haematopoietic stem cell transplantation: randomised trial protocol.

Tomas López-Espinoza, Cinara Sacomori, Paulina Araya-Castro...

https://pubmed.ncbi.nlm.nih.gov/39461860