Mucositis OralPBMNCT06623305
A Clinical Trial of the Administration of Light Therapy to Prevent Mouth Sores in Children With Cancer
A study testing Photobiomodulation for prevention arm and Photobiomodulation for exploratory arm in people with Mucositis Oral, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Mucositis Oral
- What is being tested?
- Photobiomodulation for prevention arm and Photobiomodulation for exploratory arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Patients admitted on BMT service
- Patients currently experiencing mucositis with a CTCAE grade 4 oral mucositis or higher
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Elissa Shulta, DNP, 414-266-5407, EShulta@childrenswi.org
Peter Shaw, MD, 414-955-4086, pshaw@mcw.edu
About this study
Official title: Photobiomodulation Therapy for the Prevention of Mucositis in Pediatric Oncology Patients
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?
Read more
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.
- Conditions
- Mucositis Oral
- Being tested
- Photobiomodulation for prevention arm, Photobiomodulation for exploratory arm
- Keywords
- Photobiomodulation, Mucositis, Oral Mucositis
- Medical subject headings
- Stomatitis, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation for prevention armDevice
Also called PBM, Light therapy
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.
Patients will continue to receive light therapy in the home setting through day +8 of their chemotherapy cycle using the Luminance Device.
Photobiomodulation for exploratory armDevice
Also called PBM, Light therapy
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.
Patients will continue to receive light therapy in the home setting through day +8 of their chemotherapy cycle using the Luminance Device.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Prospective data review of patients who did not receive light therapy |
| Prevention Arm | Active comparator | Prospective data review of patients who did receive light therapy Receives: Device: Photobiomodulation for prevention arm |
| Exploratory Arm | Active comparator | Prospective review of patients with Trisomy 21 who did receive light therapy Receives: Device: Photobiomodulation for exploratory arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the feasibility of using PBM in pediatric oncology patients.
Feasibility of PBM will be assessed by the RN completing a survey using a 5-point Likert scale (5 being strongly agree and 1 being strongly disagree) to evaluate the ease of delivery of PBM therapy. A score of ≥3 indicates that the PBM therapy was feasible.
Measured: 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.
Acceptability of PBM will be assessed by the patient/caregiver completing a survey using a 5-point Likert scale (5 being strongly agree and 1 being strongly disagree) to evaluate the patient's tolerance of the treatment. A score of ≥3 indicates acceptability of PBM therapy.
Measured: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
Secondary outcomes (2)
Evaluate the effectiveness of using PBM in reducing the incidence and severity of mucositis in pediatric oncology patients receiving chemotherapy.
This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record based on the number of unique patients with the value of "mucositis/stomatitis" in the oral mucosa flowsheet row. Additionally, mucositis onset, severity, and grade will be measured using the CTCAE grading scale and the ChIMES patient/caregiver survey
Measured: 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.
This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record, defined as the rate of MBI CLABSIs per 1,000 line days.
Measured: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Mucositis OralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-arm, prospective, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elissa Shulta, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623305
- Sponsor's protocol ID
- PRO00051962
- Acronym
- PBM
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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.
PubMed 24129238Treister 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.
PubMed 33993618Rabin 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.
PubMed 22106003Zadik 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.
PubMed 31286228Treister 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.
PubMed 26982624Miranda-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.
PubMed 34115428Lima 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.
PubMed 21203698Heimlich 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.
PubMed 37889325Chaves 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.
PubMed 25054749Antunes 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.
PubMed 28688677Cheng 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.
PubMed 22167295Pritchard 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.
PubMed 38377968Hafner 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.
PubMed 36979353de 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.
PubMed 33774891Berger 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.
PubMed 29734184