Radiation Field, Dose and Fractionation Related to Mandibular Complications

• Sponsor: Lund University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05412849
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Anticipated Duration (Months): 17.9
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Neoplasms; Osteoradionecrosis; Radiotherapy; Complications	Radiation: Radiotherapy

Study Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Is the Radiation Field, Dose and Fractionation Crucial for the Development of Mandibular Complications When Treating Malignancies in the Oropharyngeal Region?
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Skane University Hospital	Lund		Sweden

Sponsors and Collaborators

• Lund University Hospital

Investigators

• Principal Investigator: Martin Bengtsson, PhD, Lund University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lund University Hospital
• ClinicalTrials.gov Identifier: NCT05412849
• Other Study ID Numbers: LundUH
• First Posted: Jun 9, 2022
• Last Update Posted: Jun 9, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Head and Neck Neoplasms; Osteoradionecrosis

Study Results

No Results Posted as of Jun 9, 2022