protocolSection identificationModule nctId: NCT06260111, orgStudyIdInfo id: SA23I0021, briefTitle: Photobiomodulation for Oral Mucositis and Functional Impairments During Hematopoietic Stem Cell Transplantation, acronym: POMFITT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-10-30, completionDateStruct date: 2025-10-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Universidad del Desarrollo, class: OTHER, collaborators name: Agencia Nacional de Investigación y Desarrollo, collaborators name: Clínica Dávila, descriptionModule briefSummary: 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., conditionsModule conditions: Hematologic Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Assessor will be blinded only for the secondary outcomes. The person responsible for statistical analyses will also be blinded., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Photobiomodulation, interventions name: Usual care, outcomesModule primaryOutcomes measure: Oral Mucositis, primaryOutcomes measure: Level of Pain, secondaryOutcomes measure: Handgrip strength, secondaryOutcomes measure: Exercise tolerance, secondaryOutcomes measure: Physical fitness, secondaryOutcomes measure: Health related quality of life, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: Use of opioids, secondaryOutcomes measure: Body mass index, secondaryOutcomes measure: Nutritional status, secondaryOutcomes measure: Daily calorie intake, secondaryOutcomes measure: Arm circumference, secondaryOutcomes measure: Triceps skinfold, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinica Dávila, city: Santiago, state: Metropolitana, zip: 8431657, country: Chile, contacts name: Tomás A López-Espinoza, MSc.C., role: CONTACT, phone: +56962056755, email: tlopeze@udd.cl, contacts name: Hernán López, MD, role: CONTACT, phone: +56966795985, email: hernan.lopez@davila.cl, contacts name: Monica Peña, Nurse, role: SUB_INVESTIGATOR, geoPoint lat: -33.45694, lon: -70.64827, hasResults: False