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

NCT06260111 | Recruiting

• 1 other identifier: SA23I0021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Cancer

Keywords

Low level laser therapy; Hematopoietic stem cell transplantation; Oral mucositis; Physical fitness; Physical therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

• 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.

  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)

Secondary Outcomes (13)

• Handgrip strength

  Through study completion on the day of hospital discharge, an average of 1 month

• Exercise tolerance

  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

Study Arms (2)

Photobiomodulation group

EXPERIMENTAL

Photobiomodulation and usual care (education, cryotherapy, and mouth hygiene).

Device: Photobiomodulation; Other: Usual care

Control group

OTHER

Usual care (education, cryotherapy, and mouth hygiene).

Other: Usual care

Interventions

Photobiomodulation DEVICE

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.

Also known as: Low level laser therapy

Photobiomodulation group

Usual care OTHER

Usual care for oral mucositis includes education, cryotherapy, and mouth hygiene.

Control group; Photobiomodulation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad del Desarrollo: lead
• Agencia Nacional de Investigación y Desarrollo: collaborator
• Clínica Dávila: collaborator

Study Sites (1)

Clinica Dávila

Santiago, Santiago Metropolitan, 8431657, Chile

RECRUITING

Related Publications (9)

• 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.

  PMID: 26248655 BACKGROUND

• 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.

  PMID: 32786044 BACKGROUND

• 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.

  PMID: 36110957 BACKGROUND

• 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.

  PMID: 35631314 BACKGROUND

• 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.

  PMID: 29210933 BACKGROUND

• 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.

  PMID: 9051246 BACKGROUND

• 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.

  PMID: 22613940 BACKGROUND

• 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.

  PMID: 10380242 BACKGROUND

• 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.

  PMID: 39461860 DERIVED

Related Links

• Definition of outcomes

MeSH Terms

Conditions

Hematologic Neoplasms; Stomatitis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Cinara Sacomori, Ph.D.

  Universidad del Desarrollo

  PRINCIPAL INVESTIGATOR

• Paulina A Araya-Castro, Ph.D.

  Universidad del Desarrollo

  STUDY CHAIR

Central Study Contacts

Cinara Sacomori, Ph.D.

CONTACT

+562 23279661; csacomori@udd.cl

Tomás Lopez, MScC.

CONTACT

+56962056755; tlopeze@udd.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessor will be blinded only for the secondary outcomes. The person responsible for statistical analyses will also be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 15, 2024
• Study Start: June 10, 2024
• Primary Completion: March 30, 2025
• Study Completion: October 30, 2025
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data of study protocol will be available from the completion of the study up to 10 years after.
• Access Criteria: Regulatory institutions such as Ethical Committee Board and Funding Audits will have full access to IPD if they require so.

Locations

CL (1)