Clinical trial · Interventional
Evaluation of Prophylactic Photobiomodulation Therapy in Patients With Osteosarcoma
Evaluation of Prophylactic Photobiomodulation Therapy in Patients With Osteosarcoma Undergoing High Doses of Methotrexate
NCT06217224CI-TRIAL-00073153PBMT/MTXunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to evaluate the photobiomodulation therapy (PBMT) for the prevention of oral mucositis in osteosarcoma patients submitted to high doses of methotrexate, through two different protocols. As a hypothesis, photobiomodulation for the prevention of oral mucositis after cycles of Cisplatin, Doxorubicin and Methotrexate is more effective than just the application of preventive low-power laser after Methotrexate alone.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mucositis Oral | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preventive photobiomodulation Therapy (PBMT) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Preventative photobiomodulation therapy arm only in methotrexate weeks.
- description
- The application of preventive photobiomodulation therapy (PBMT) will be carried out on the day of methotrexate infusion (D1) and until the patient reaches a serum concentration equal to or less than 0.3 mmol/L.
- interventionNames
- Other: Preventive photobiomodulation Therapy (PBMT)
- type
- EXPERIMENTAL
- label
- Preventive photobiomodulation therapy arm in the weeks of methotrexate, cisplatin and doxorubicin.
- description
- The application of preventive photobiomodulation therapy will be performed on the days of doxorubicin infusion and cisplatin and on the day after the doxorubicin infusion; on the day of the methotrexate infusion and until the patient reaches a serum concentration equal to or less than 0.3 mmol /L.
- interventionNames
- Other: Preventive photobiomodulation Therapy (PBMT)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Patients enrolled at INCA diagnosed with OS (ICD10-C41), aged 0 to 19 years; * Patients with indication for Glato chemotherapy protocol, which will use high doses of MTX (HD-MTX (\>1 g/m2). * Patients who, after receiving information and instructions, signed the patient's informed consent/assent form, in accordance with Resolution 466/12 of the National Health Council. Exclusion Criteria: \- Patients who do not agree with the proposed treatment.
References
Publications (22)
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- BACKGROUNDSteliarova-Foucher E, Colombet M, Ries LAG, Moreno F, Dolya A, Bray F, Hesseling P, Shin HY, Stiller CA; IICC-3 contributors. International incidence of childhood cancer, 2001-10: a population-based registry study. Lancet Oncol. 2017 Jun;18(6):719-731. doi: 10.1016/S1470-2045(17)30186-9. Epub 2017 Apr 11. PMID 28410997
- BACKGROUNDParkin DM, Stiller CA, Nectoux J. International variations in the incidence of childhood bone tumours. Int J Cancer. 1993 Feb 1;53(3):371-6. doi: 10.1002/ijc.2910530305. PMID 8428791
- BACKGROUNDGaebler M, Silvestri A, Haybaeck J, Reichardt P, Lowery CD, Stancato LF, Zybarth G, Regenbrecht CRA. Three-Dimensional Patient-Derived In Vitro Sarcoma Models: Promising Tools for Improving Clinical Tumor Management. Front Oncol. 2017 Sep 11;7:203. doi: 10.3389/fonc.2017.00203. eCollection 2017. PMID 28955656
- BACKGROUNDMutsaers AJ, Walkley CR. Cells of origin in osteosarcoma: mesenchymal stem cells or osteoblast committed cells? Bone. 2014 May;62:56-63. doi: 10.1016/j.bone.2014.02.003. Epub 2014 Feb 14. PMID 24530473
- BACKGROUNDArndt CA, Crist WM. Common musculoskeletal tumors of childhood and adolescence. N Engl J Med. 1999 Jul 29;341(5):342-52. doi: 10.1056/NEJM199907293410507. No abstract available. PMID 10423470
- BACKGROUNDHoward SC, McCormick J, Pui CH, Buddington RK, Harvey RD. Preventing and Managing Toxicities of High-Dose Methotrexate. Oncologist. 2016 Dec;21(12):1471-1482. doi: 10.1634/theoncologist.2015-0164. Epub 2016 Aug 5.