Status:
UNKNOWN
Effectiveness of Photobiomodulation Protocols in Radiation-induced Oral Side Effects in H&N Cancer Patients
Lead Sponsor:
Federal University of Rio Grande do Sul
Collaborating Sponsors:
AC Camargo Cancer Center
Instituto do Cancer do Estado de São Paulo
Conditions:
Mucositis
Xerostomia
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Head and neck cancer (HNC) are among the most frequent malignancies in the world. The main treatment modalities for HNC are surgical excision, radiotherapy (RT), and chemotherapy (CT). Severe oral seq...
Detailed Description
Radiotherapy (RT) and chemotherapy-induced oral side effects, as oral mucositis, and xerostomia are extremely challenging for professionals in the supportive care for head and neck squamous cell carci...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of cancer in the oral cavity and oropharynx any clinical stage based on TNM staging of head and neck cancer;
- Patients who received oral care prior to oncological treatment;
- Patients who will receive conformational radiotherapy (RT-C3D) or Intensity-modulated radiotherapy (IMRT) from 50 Gy to 70 Gy (primary radiation field) in daily doses of 1.8-2, 12 Gy divided five times per week (from Monday to Friday), totalizing 6 to 7 weeks of treatment. They may receive exclusive RT or with chemotherapy concomitant with cisplatin (100 mg/m2 every 21 days or 50 mg/m2 per week);
- Patients feeding orally or by parenteral nutrition;
- Patients who agree to participate in the study after reading, filling, and signing the Consent Form for Participation in Clinical Research.
Exclusion
- Patients who develop head and neck radiodermatitis and for this reason interrupt the survey;
- Patients who do not appear in four or more PBMT or RT sessions.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT05242991
Start Date
March 1 2021
End Date
October 1 2024
Last Update
March 9 2023
Active Locations (1)
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1
Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil