A Clinical Trial of the Administration of Light Therapy to Prevent and Treat Mouth Sores in Children With Cancer

NCT06623305 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: PRO00051962
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if light therapy can prevent and/or treat mouth sores in children with cancer. The main questions it aims to answer are: Is it reasonable and acceptable to provide light therapy for children with cancer? Does light therapy prevent and treat mouth sores related to medical treatment? Researchers will compare children who did not receive light therapy before the clinical trial to children who receive light therapy during the clinical trial to see if light therapy helps to prevent and treat mucositis. Participants will:

• Tell the nurse their pain score, related to their mouth sores, before receiving light therapy.
• Have picture taken of their mouth to look for mouth sores.
• Receive light therapy every other day while admitted to the hospital on the cancer unit or while admitted to an alternate unit.

Conditions

Mucositis Oral

Keywords

Photobiomodulation; Mucositis; Oral Mucositis

Outcome Measures

Primary Outcomes (1)

• Evaluate the feasibility and acceptability of using PBM in pediatric oncology patients.

  This will be assessed through a questionnaire completed by the RN administering the PBM therapy and will focus on the patient's tolerance level rated on a numerical scale, the nurse's perception of feasibility, and length of treatment in minutes.

  From date of enrollment until date of last PBM treatment, assessed up to 2 years.

Secondary Outcomes (9)

• Evaluate the effectiveness of using PBM based on mucositis onset

  From date of enrollment until date of last PBM treatment, assessed up to 2 years.

• Evaluate the effectiveness of using PBM based on mucositis severity.

  From date of enrollment until date of last PBM treatment, assessed up to 2 years.

• Evaluate the effectiveness of using PBM based on mucositis duration.

  From date of enrollment until date of last PBM treatment, assessed up to 2 years.

• Evaluate the effectiveness of using PBM based on length of stay.

  From date of enrollment until date of last PBM treatment, assessed up to 2 years.

• Evaluate the effectiveness of using PBM based on narcotic usage.

  From date of enrollment until date of last PBM treatment, assessed up to 2 years.

Study Arms (2)

Retrospective Arm

NO INTERVENTION

Retrospective data review of patients who did not receive light therapy

Prospective Arm

ACTIVE COMPARATOR

Prospective data review of patients who receive light therapy

Device: Photobiomodulation

Interventions

Photobiomodulation DEVICE

Light therapy will be administered using the cluster probe on the external cheeks bilaterally and intraorally using the lollipop probe for patients ≥7 years of age. Patients \< 7 years of age will not receive intraoral treatment with the lollipop. Instead, they will be asked to open their mouth while the covered cluster probe is held externally to treat their intraoral membranes. Each treatment (both external cheeks and intraoral buccal region) will be administered over 1 min with a Modulation Frequency 2.5Hz, Skin Conduction nS 001, and Beam Power mW 000, for a total treatment time of 3 minutes.

Also known as: PBM

Prospective Arm

Eligibility Criteria

• Age: Up to 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Admitted to oncology unit, PICU, or on an alternate acute care unit.
• Diagnosis:
• Following diagnoses until achieve count recover (ANC≥500), the patient has no clinical signs of mucositis, or is discharged i. ALL interim-maintenance high dose Methotrexate ii. ALL with trisomy 21 receiving high dose Methotrexate iii. AML iv. Neuroblastoma (excluding admissions for antibody treatment) v. Burkitt lymphoma vi. Osteosarcoma receiving high dose Methotrexate vii. Germ cell tumors receiving Etoposide viii. Rhabdomyosarcoma ix. Ewing sarcoma
• Head/neck cancers receiving radiation
• Able to speak and understand English or Spanish

You may not qualify if:

• Unwilling to participate
• Do not meet eligibility criteria outline above

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (14)

• Zadik Y, Arany PR, Fregnani ER, Bossi P, Antunes HS, Bensadoun RJ, Gueiros LA, Majorana A, Nair RG, Ranna V, Tissing WJE, Vaddi A, Lubart R, Migliorati CA, Lalla RV, Cheng KKF, Elad S; Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). Systematic review of photobiomodulation for the management of oral mucositis in cancer patients and clinical practice guidelines. Support Care Cancer. 2019 Oct;27(10):3969-3983. doi: 10.1007/s00520-019-04890-2. Epub 2019 Jul 8.

  PMID: 31286228 BACKGROUND

• Treister NS, London WB, Guo D, Malsch M, Verrill K, Brewer J, Margossian S, Duncan C. A Feasibility Study Evaluating Extraoral Photobiomodulation Therapy for Prevention of Mucositis in Pediatric Hematopoietic Cell Transplantation. Photomed Laser Surg. 2016 Apr;34(4):178-84. doi: 10.1089/pho.2015.4021. Epub 2016 Mar 16.

  PMID: 26982624 BACKGROUND

• Miranda-Silva W, da Fonseca FP, Gomes AA, Mafra ABB, Rocha V, Fregnani ER. Oral mucositis in paediatric cancer patients undergoing allogeneic hematopoietic stem cell transplantation preventively treated with professional dental care and photobiomodulation: Incidence and risk factors. Int J Paediatr Dent. 2022 Mar;32(2):251-263. doi: 10.1111/ipd.12850. Epub 2021 Jul 20.

  PMID: 34115428 BACKGROUND

• Lima AG, Antequera R, Peres MP, Snitcosky IM, Federico MH, Villar RC. Efficacy of low-level laser therapy and aluminum hydroxide in patients with chemotherapy and radiotherapy-induced oral mucositis. Braz Dent J. 2010;21(3):186-92. doi: 10.1590/s0103-64402010000300002.

  PMID: 21203698 BACKGROUND

• Heimlich FV, de Arruda JAA, Pereira NM, Faria LDS, Abreu LG, Ferreira MVL, Kakehasi FM, Travassos DV, Silva TA, Mesquita RA. Proposal of a prophylactic photobiomodulation protocol for chemotherapy-induced oral and oropharyngeal mucositis: a randomized clinical trial. Lasers Med Sci. 2023 Oct 27;38(1):245. doi: 10.1007/s10103-023-03916-w.

  PMID: 37889325 BACKGROUND

• Chaves ME, Araujo AR, Piancastelli AC, Pinotti M. Effects of low-power light therapy on wound healing: LASER x LED. An Bras Dermatol. 2014 Jul-Aug;89(4):616-23. doi: 10.1590/abd1806-4841.20142519.

  PMID: 25054749 BACKGROUND

• Antunes HS, Herchenhorn D, Small IA, Araujo CMM, Viegas CMP, de Assis Ramos G, Dias FL, Ferreira CG. Long-term survival of a randomized phase III trial of head and neck cancer patients receiving concurrent chemoradiation therapy with or without low-level laser therapy (LLLT) to prevent oral mucositis. Oral Oncol. 2017 Aug;71:11-15. doi: 10.1016/j.oraloncology.2017.05.018. Epub 2017 Jun 3.

  PMID: 28688677 BACKGROUND

• Cheng KK, Lee V, Li CH, Yuen HL, Epstein JB. Oral mucositis in pediatric and adolescent patients undergoing chemotherapy: the impact of symptoms on quality of life. Support Care Cancer. 2012 Oct;20(10):2335-42. doi: 10.1007/s00520-011-1343-1. Epub 2011 Dec 14.

  PMID: 22167295 RESULT

• Pritchard M, Ogg SW, Bosi J, Mandrell BN. Utilization of Photobiomodulation for the Prevention and Treatment of Oral Mucositis. J Pediatr Hematol Oncol Nurs. 2024 Mar-Apr;41(2):107-113. doi: 10.1177/27527530231214525. Epub 2024 Feb 20.

  PMID: 38377968 RESULT

• Hafner D, Hrast P, Tomazevic T, Jazbec J, Kavcic M. Photobiomodulation for Chemotherapy-Induced Oral Mucositis in Pediatric Patients. Biomolecules. 2023 Feb 23;13(3):418. doi: 10.3390/biom13030418.

  PMID: 36979353 RESULT

• de Farias Gabriel A, Silveira FM, Curra M, Schuch LF, Wagner VP, Martins MAT, da Silveira Matte U, Siebert M, Botton MR, Brunetto AT, Gregianin LJ, Martins MD. Risk factors associated with the development of oral mucositis in pediatric oncology patients: Systematic review and meta-analysis. Oral Dis. 2022 May;28(4):1068-1084. doi: 10.1111/odi.13863. Epub 2021 Apr 9.

  PMID: 33774891 RESULT

• Berger K, Schopohl D, Bollig A, Strobach D, Rieger C, Rublee D, Ostermann H. Burden of Oral Mucositis: A Systematic Review and Implications for Future Research. Oncol Res Treat. 2018;41(6):399-405. doi: 10.1159/000487085. Epub 2018 May 3.

  PMID: 29734184 RESULT

• Antunes HS, de Azevedo AM, da Silva Bouzas LF, Adao CA, Pinheiro CT, Mayhe R, Pinheiro LH, Azevedo R, D'Aiuto de Matos V, Rodrigues PC, Small IA, Zangaro RA, Ferreira CG. Low-power laser in the prevention of induced oral mucositis in bone marrow transplantation patients: a randomized trial. Blood. 2007 Mar 1;109(5):2250-5. doi: 10.1182/blood-2006-07-035022. Epub 2006 Oct 19.

  PMID: 17053058 RESULT

• Alsheyyab F, Al-Momani D, Kasht R, Kamal A, Abusalem D, Al-Qasem W. Impact of severe oral mucositis in pediatric cancer patients on resource utilization and cancer treatment plans. Int J Clin Pharm. 2021 Oct;43(5):1322-1326. doi: 10.1007/s11096-021-01253-y. Epub 2021 Mar 3.

  PMID: 33660192 RESULT

MeSH Terms

Conditions

Stomatitis; Mucositis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Elissa Shulta, DNP

CONTACT

414-266-5407; EShulta@childrenswi.org

Peter Shaw, MD

CONTACT

414-955-4086; pshaw@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective - Retrospective Longitudinal Study

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 2, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 24, 2025

Record last verified: 2025-10

Locations

US (1)