Evaluation of Prophylactic Photobiomodulation Therapy in Patients With Osteosarcoma Undergoing High Doses of Methotrexate

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 19
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Brazil
National Cancer Institute
RECRUITING
Rio De Janeiro
Contact Information
Primary
Ana Maria D da Costa
anadias257@gmail.com
+55 21 3207 - 1859
Backup
Heliton S Antunes, Dr.
hspindola@inca.gov.br
+55 21 3207 - 1859
Time Frame
Start Date: 2022-10-17
Estimated Completion Date: 2025-07-30
Participants
Target number of participants: 53
Treatments
Active_comparator: Preventative photobiomodulation therapy arm only in methotrexate weeks.
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.
Experimental: Preventive photobiomodulation therapy arm in the weeks of methotrexate, cisplatin and doxorubicin.
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.
Sponsors
Leads: Instituto Nacional de Cancer, Brazil

This content was sourced from clinicaltrials.gov

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