Radiation Field, Dose and Fractionation Related to Mandibular Complications

NCT05412849 | Recruiting

• 1 other identifier: LundUH
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Neoplasms; Osteoradionecrosis; Radiotherapy; Complications

Outcome Measures

Primary Outcomes (1)

• Complications related to dose, time and position of radiotherapy

  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.

  The measurements will be done from the end of radiotherapy and atleast 1 year postoperatively.

Interventions

Radiotherapy RADIATION

Radiotherapy site, time perspective and dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutively included patients treated for head and neck neoplasms with a combination of surgery and radiotherapy.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lund University Hospital: lead

Study Sites (1)

Skane University Hospital

Lund, Sweden

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Osteoradionecrosis

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Martin Bengtsson, PhD

  Lund University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip Fransson, Msc

CONTACT

0046 761077255; philip.fransson@skane.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: June 9, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)