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.
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.
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.
Parallel
Photobiomodulation
DevicePhotobiomodulation 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
Other interventionUsual care for oral mucositis includes education, cryotherapy, and mouth hygiene.
Oral Mucositis
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.
Level of Pain
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.
Handgrip strength
It is the maximal isometric strength of the handgrip that will be measured in KgF with Hydraulic Hand Dynamometer (Jamar Digital Plus®).
Exercise tolerance
The exercise capacity of an individual as measured by endurance (maximal exercise duration and/or maximal attained work load) during an EXERCISE TEST. It will be assessed with the 2-Minute Walking Test is a functional test that assesses an individual's aerobic capacity and is used as a performance measure.
Physical fitness
It is the ability to carry out daily tasks and perform physical activities in a highly functional state, often as a result of physical conditioning. Physical fitness will be evaluated with the 30-Second Sit and Stand (SST30') assesses the ability to rise from a chair and sit back down, as well as the strength and functionality of the lower limbs.
Health related quality of life
Health related quality of life is a generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease. Quality of life will be assessed using the validated and widely used instrument in the oncology population undergoing hematopoietic stem cell transplantation, the Functional Assessment of Cancer Therapy-Bone Marrow Transplant questionnaire.
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Universidad del Desarrollo
Lead sponsor
Agencia Nacional de Investigación y Desarrollo
Collaborator
Clínica Dávila
Collaborator
