Not yet recruiting NCT06623305
A Clinical Trial of the Administration of Light Therapy to Prevent Mouth Sores in Children With Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Photobiomodulation for prevention arm, Photobiomodulation for exploratory arm.
- Who it may be relevant to
- Registry conditions: Mucositis Oral. Basic parameters: up to 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Photobiomodulation Therapy for the Prevention of Mucositis in Pediatric Oncology Patients
Overview
The goal of this clinical trial is to learn if light therapy can prevent 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 mouth sores related to medical treatment? Researchers will compare children who do not receive light therapy to children who do receive light therapy during the clinical trial to see if light therapy helps to prevent mucositis. Participants will: * Complete a survey. * Have picture taken of their mouth to look for mouth sores. * Receive light therapy every day while admitted to the hospital on the cancer unit or while admitted to an alternate unit, and continue to receive light therapy in the home setting until they reach 8 days after the start of their chemotherapy cycle.
Interventions
- Device Photobiomodulation for prevention arm
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 Fr - Device Photobiomodulation for exploratory arm
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 Fr
Primary outcome measures
- Evaluate the feasibility of using PBM in pediatric oncology patients. [Time frame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.]
- Evaluate the acceptability of using PBM in pediatric oncology patients. [Time frame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.]
Secondary outcome measures (2)
- Evaluate the effectiveness of using PBM in reducing the incidence and severity of mucositis in pediatric oncology patients receiving chemotherapy. [Time frame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.]
- Evaluate the effectiveness of using PBM based on MBI CLABSI rate. [Time frame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.]
Eligibility criteria
Inclusion criteria
- Current and new diagnosis patients consented upon admission if deemed eligible
- Ages 0-30
- Admitted to CW oncology/BMT inpatient unit, PICU, or West 5
- Chemotherapy regimen: Methotrexate ≥5 g/m2 (or ≥1 g/m2 if Trisomy 21) OR Anthracycline ≥60 mg/m2
- Able to speak and understand English or Spanish
Exclusion criteria
- Patients admitted on BMT service
- Patients currently experiencing mucositis with a CTCAE grade 4 oral mucositis or higher
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Medical College of Wisconsin — Milwaukee
Publications
- Jacobs S, Baggott C, Agarwal R, Hesser T, Schechter T, Judd P, Tomlinson D, Beyene J, Sung L. Validation of the Children's International Mucositis Evaluation Scale (ChIMES) in paediatric cancer and SCT. Br J Cancer. 2013 Nov 12;109(10):2515-22. doi: 10.1038/bjc.2013.618. Epub 2013 Oct 15. PMID 24129238
- Treister NS, Nieder M, Baggott C, Olson E, Lo T, Jin X, Gao Y, Chen L, Dang H, Sung L. Validation of healthcare professional proxy-reported children's International Mucositis Evaluation Scale. Oral Dis. 2023 Mar;29(2):747-754. doi: 10.1111/odi.13918. Epub 2021 May 26. PMID 33993618
- Rabin KR, Smith J, Kozinetz CA. Myelosuppression and infectious complications in children with Down syndrome and acute lymphoblastic leukemia. Pediatr Blood Cancer. 2012 Apr;58(4):633-5. doi: 10.1002/pbc.23371. Epub 2011 Nov 21. PMID 22106003
- 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 i PMID 31286228
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT06623305 · PRO00051962