Evaluation of Prophylactic Photobiomodulation Therapy in Patients With Osteosarcoma

NCT06217224 | Unknown DMC

• 1 other identifier: 54417221.3.0000.5274
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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. 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

Mucositis Oral

Keywords

osteosarcoma; Mucositis Oral; Methotrexate Toxicity; Low-Level Light Therapy

Outcome Measures

Primary Outcomes (1)

• Evaluate the best photobiomodulation protocol for preventing oral mucositis

  To compare the effectiveness of two photobiomodulation protocols for the prevention of oral mucositis in patients with osteosarcoma undergoing high doses of methotrexate.

  Throughout the entire glato protocol.

Secondary Outcomes (5)

• Incidence of Oral Mucositis

  From the first day of infusion of each chemotherapy agent to the third and seventh day of the same week of infusion throughout the entire glato protocol.

• Oral mucositis development time

  From the first day of infusion of each chemotherapy agent to the third and seventh day of the same week of infusion throughout the entire glato protocol.

• Assess salivary flow

  From the first day of infusion of each chemotherapy agent to the third and seventh day of the same week of infusion throughout the entire glato protocol.

• Methotrexate serum levels

  From the first day of meotrexate infusion until serum regularization.

• Hospital internment

  Throughout the entire glato protocol.

Study Arms (2)

Preventative photobiomodulation therapy arm only in methotrexate weeks.

ACTIVE COMPARATOR

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.

Other: Preventive photobiomodulation Therapy (PBMT)

Preventive photobiomodulation therapy arm in the weeks of methotrexate, cisplatin and doxorubicin.

EXPERIMENTAL

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.

Other: Preventive photobiomodulation Therapy (PBMT)

Interventions

Preventive photobiomodulation Therapy (PBMT) OTHER

The application of preventive TLBP will be performed with a laser device containing an aluminum phosphide and indium gallium diode (InGaAlP) emitting radiation in the red region of the electromagnetic spectrum (660 nm) with a power of 100mW and a beam area of 0.03 cm2 . An energy of 1J/point and an energy density of 33.3 J/cm2/point were determined, which will be applied punctually, with a distance between the points of 1cm, for 10s per point, totaling 9 points per region.

Also known as: Preventive Low Power Laser Therapy (TLBP )

Preventative photobiomodulation therapy arm only in methotrexate weeks.; Preventive photobiomodulation therapy arm in the weeks of methotrexate, cisplatin and doxorubicin.

Eligibility Criteria

• Age: Up to 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead

Study Sites (1)

National Cancer Institute

Rio de Janeiro, 20230-130, Brazil

RECRUITING

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MeSH Terms

Conditions

Stomatitis; Osteosarcoma

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Officials

• Heliton S Antunes, Dr.

  National Cancer Institute (NCI)

  STUDY DIRECTOR

Central Study Contacts

Ana Maria D da Costa

CONTACT

+55 21 3207 - 1859; anadias257@gmail.com

Heliton S Antunes, Dr.

CONTACT

+55 21 3207 - 1859; hspindola@inca.gov.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of oncology

Model Details: Phase 3, randomized study with patients diagnosed with OS, enrolled at INCA, candidates for the Glato protocol (chemotherapy -doxorubicin, cisplatin, dexamethasone and MTX + surgery). Patients will be randomized through the computerized system to groups 1 or 2. Randomization will be performed in permuted blocks.

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: January 22, 2024
• Study Start: October 17, 2022
• Primary Completion: June 30, 2025
• Study Completion: July 30, 2025
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)