Radiation Field, Dose and Fractionation Related to Mandibular Complications

Recruiting

• Conditions: Radiotherapy; Complications; Head and Neck Neoplasms; Osteoradionecrosis

• Registration Number: NCT05412849
• Lead Sponsor: Lund University Hospital

Brief Summary

Radiotherapy is inhibiting the healing capacity of the mandibular bone. Late complications as bone exposure, fracture of the jaw, osteoradionecrosis might be a consequence of this vulnerability. A factor that could be involved in the development of complications is field of radiation. There are limited number of studies investigating this relation.

Retrospective analysis of a head and neck oncology register with prospectively included patients will be performed. Patients will be related to the University hospitals in Lund, Umea, Orebro, Stockholm. A thorough analysis of the medical journals in this group of patients will be performed. Included patients have been treated with combination of surgery and radiotherapy to treat malignancies in the head and neck region. At least 12 months follow up period is needed for inclusion.

The scientific aim is to investigate weather the field of radiation and fractionation is crucial for developing the formentioned complications.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-09
• Study Start: 2023-01-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23
• Primary Completion: 2025-01
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Clinical diagnosis of the head and neck malignancy
• Must have recieved radiotherapy as primary treatment alone or combination treatment together with surgery

Exclusion criteria

• less than 12 months follow up
• Under 18 years of age

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complications related to dose, time and position of radiotherapy	The measurements will be done from the end of radiotherapy and atleast 1 year postoperatively.	Complications as Osteoradionecrosis will be identified and compared with the dose of radiation, how long ago since the radiotherapy was given and where in the mouth the complication has developed.

Trial Locations

Locations (1)

Skane University Hospital; 🇸🇪 Lund, Sweden