Status:

RECRUITING

Evaluation of Prophylactic Photobiomodulation Therapy in Patients With Osteosarcoma

Lead Sponsor:

Instituto Nacional de Cancer, Brazil

Conditions:

Mucositis Oral

Eligibility:

All Genders

Up to 19 years

Phase:

NA

Brief 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...

Detailed Description

This is a phase 3, randomized study, with patients diagnosed with osteosarcoma, enrolled at national cancer institute in Brazil (INCA), candidates for the Glato protocol (chemotherapy with doxorubicin...

Eligibility Criteria

Inclusion

  • 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

  • \- Patients who do not agree with the proposed treatment.

Key Trial Info

Start Date :

October 17 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 30 2025

Estimated Enrollment :

53 Patients enrolled

Trial Details

Trial ID

NCT06217224

Start Date

October 17 2022

End Date

July 30 2025

Last Update

January 22 2024

Active Locations (1)

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1

National Cancer Institute

Rio de Janeiro, Brazil, 20230-130