Comparing laser treatments to prevent mouth sores in children with cancer
Comparison of Two Prophylactic Photobiomodulation Protocols in Chemoinduced Oral Mucositis in Pediatric and Adolescent Oncology Patients: a Randomized, Controlled, Blinded Clinical Trial
This study is testing two types of laser treatments to see which one works better to prevent mouth sores in children and teens with cancer who are getting chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 1 Month to 18 Years |
| Sex | All |
| Sponsor | Federal University of Rio Grande do Sul Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, doxorubicin, radiation |
| Locations | 1 site (Porto Alegre, Rio Grande do Sul) |
| Trial ID | NCT05811195 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two different photobiomodulation therapy protocols using low-power and high-power lasers to prevent oral mucositis in pediatric and adolescent oncology patients undergoing chemotherapy. The study will assess the impact of these treatments on the severity of oral mucositis, as well as the patients' quality of life, anxiety, depression, and pain levels. Additionally, it will evaluate inflammatory markers in saliva to understand the biological effects of the treatments. Conducted at the Hospital de Clínicas de Porto Alegre and A.C. Camargo Center, this randomized and controlled trial will involve informed consent from participants and their guardians.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric and adolescent patients diagnosed with malignant neoplasia who are receiving specific chemotherapy protocols.
Not a fit: Patients over the age of 18 or those undergoing hematopoietic stem cell transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence and severity of painful mouth sores in children undergoing cancer treatment.
How similar studies have performed: Previous studies have shown promising results with photobiomodulation therapy in reducing oral mucositis, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of malignant neoplasia (hematological or solid tumors); * Responsible and participants agree to the study participation after reading and signing the Informed Consent Form (ICF) and Informed Term of Consent (TALE) for participation in Clinical Research; * They performed the chemotherapy infusions hospitalized in the pediatric oncology department of the 3rd east of HCPA; * Received the following chemotherapy protocols: MTX-HD, combination chemotherapy of MTX-HD, doxorubicin and cyclophosphamide; and MTX-HD and cyclophosphamide. Exclusion Criteria: * Participants will be excluded who: * Patients over the age of 18 years * Patients who will undergo HSCT
Where this trial is running
Porto Alegre, Rio Grande do Sul
- Federal University of Rio Grande do Sul — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
Study contacts
- Principal investigator: Manoela D Martins, PhD — Federal University of Rio Grande do Sul
- Study coordinator: Manoela D Martins, PhD
- Email: manomartins@gmail.com
- Phone: 555133085011
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.