Using light therapy to prevent mouth sores in young osteosarcoma patients
Evaluation of Prophylactic Photobiomodulation Therapy in Patients With Osteosarcoma Undergoing High Doses of Methotrexate
NA · Instituto Nacional de Cancer, Brazil · NCT06217224
This study is testing if light therapy can help young osteosarcoma patients avoid painful mouth sores while they receive chemotherapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 53 (estimated) |
| Ages | N/A to 19 Years |
| Sex | All |
| Sponsor | Instituto Nacional de Cancer, Brazil (other gov) |
| Drugs / interventions | chemotherapy, methotrexate, Doxorubicin, radiation |
| Locations | 1 site (Rio De Janeiro) |
| Trial ID | NCT06217224 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of photobiomodulation therapy (PBMT) in preventing oral mucositis in osteosarcoma patients undergoing high doses of methotrexate. Patients will be randomly assigned to receive either PBMT or standard preventive care during their chemotherapy treatment. The study aims to determine if PBMT is more effective than traditional methods in reducing the incidence of oral mucositis. Participants will be enrolled at the National Cancer Institute in Brazil and will follow specific oral hygiene protocols throughout the treatment.
Who should consider this trial
Good fit: Ideal candidates are patients aged 0 to 19 years diagnosed with osteosarcoma and scheduled for high-dose methotrexate chemotherapy.
Not a fit: Patients who do not consent to the proposed treatment or are not eligible based on the study criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce the occurrence of painful oral mucositis in young patients undergoing chemotherapy for osteosarcoma.
How similar studies have performed: While the approach of using PBMT is gaining interest, this specific application in osteosarcoma patients undergoing high-dose methotrexate is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Rio De Janeiro
- National Cancer Institute — Rio De Janeiro, Brazil (RECRUITING)
Study contacts
- Study coordinator: Ana Maria D da Costa
- Email: anadias257@gmail.com
- Phone: +55 21 3207 - 1859
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mucositis Oral, osteosarcoma, Methotrexate Toxicity, Low-Level Light Therapy