Photobiomodulation for Oral Mucositis and Functional Impairments During Hematopoietic Stem Cell Transplantation
NCT ID: NCT06260111
Last Updated: 2024-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-06-10
2025-10-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Photobiomodulation group
Photobiomodulation and usual care (education, cryotherapy, and mouth hygiene).
Photobiomodulation
Photobiomodulation 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
Usual care for oral mucositis includes education, cryotherapy, and mouth hygiene.
Control group
Usual care (education, cryotherapy, and mouth hygiene).
Usual care
Usual care for oral mucositis includes education, cryotherapy, and mouth hygiene.
Interventions
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Photobiomodulation
Photobiomodulation 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
Usual care for oral mucositis includes education, cryotherapy, and mouth hygiene.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* With sufficient understanding of Spanish.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Agencia Nacional de Investigación y Desarrollo
OTHER
Clínica Dávila
OTHER
Universidad del Desarrollo
OTHER
Responsible Party
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Cinara Sacomori, Ph.D.
Principal Investigator
Principal Investigators
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Cinara Sacomori, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Universidad del Desarrollo
Paulina A Araya-Castro, Ph.D.
Role: STUDY_CHAIR
Universidad del Desarrollo
Locations
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Clinica Dávila
Santiago, Santiago Metropolitan, Chile
Countries
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Central Contacts
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Facility Contacts
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References
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Ferreira B, da Motta Silveira FM, de Orange FA. Low-level laser therapy prevents severe oral mucositis in patients submitted to hematopoietic stem cell transplantation: a randomized clinical trial. Support Care Cancer. 2016 Mar;24(3):1035-42. doi: 10.1007/s00520-015-2881-8. Epub 2015 Aug 7.
Elad S, Cheng KKF, Lalla RV, Yarom N, Hong C, Logan RM, Bowen J, Gibson R, Saunders DP, Zadik Y, Ariyawardana A, Correa ME, Ranna V, Bossi P; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2020 Oct 1;126(19):4423-4431. doi: 10.1002/cncr.33100. Epub 2020 Jul 28.
Robijns J, Nair RG, Lodewijckx J, Arany P, Barasch A, Bjordal JM, Bossi P, Chilles A, Corby PM, Epstein JB, Elad S, Fekrazad R, Fregnani ER, Genot MT, Ibarra AMC, Hamblin MR, Heiskanen V, Hu K, Klastersky J, Lalla R, Latifian S, Maiya A, Mebis J, Migliorati CA, Milstein DMJ, Murphy B, Raber-Durlacher JE, Roseboom HJ, Sonis S, Treister N, Zadik Y, Bensadoun RJ. Photobiomodulation therapy in management of cancer therapy-induced side effects: WALT position paper 2022. Front Oncol. 2022 Aug 30;12:927685. doi: 10.3389/fonc.2022.927685. eCollection 2022.
Tribolet P, Kaegi-Braun N, Gressies C, Baumgartner A, Wagner KH, Stanga Z, Schuetz P. Handgrip Strength Values Depend on Tumor Entity and Predict 180-Day Mortality in Malnourished Cancer Patients. Nutrients. 2022 May 23;14(10):2173. doi: 10.3390/nu14102173.
Bohannon RW, Crouch RH. Two-Minute Step Test of Exercise Capacity: Systematic Review of Procedures, Performance, and Clinimetric Properties. J Geriatr Phys Ther. 2019 Apr/Jun;42(2):105-112. doi: 10.1519/JPT.0000000000000164.
McQuellon RP, Russell GB, Cella DF, Craven BL, Brady M, Bonomi A, Hurd DD. Quality of life measurement in bone marrow transplantation: development of the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) scale. Bone Marrow Transplant. 1997 Feb;19(4):357-68. doi: 10.1038/sj.bmt.1700672.
Rikli RE, Jones CJ. Development and validation of criterion-referenced clinically relevant fitness standards for maintaining physical independence in later years. Gerontologist. 2013 Apr;53(2):255-67. doi: 10.1093/geront/gns071. Epub 2012 May 20.
Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028.
Lopez-Espinoza T, Sacomori C, Araya-Castro P, Quintiliano-Scarpelli D, Roldan P, Pena-Espinoza M, de Rezende LF, Lopez-Vidal H. Photobiomodulation therapy to prevent oral mucositis and functional impairment in adult patients with haematological cancer undergoing haematopoietic stem cell transplantation: randomised trial protocol. BMJ Open. 2024 Oct 26;14(10):e088073. doi: 10.1136/bmjopen-2024-088073.
Related Links
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Definition of outcomes
Other Identifiers
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SA23I0021
Identifier Type: -
Identifier Source: org_study_id
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