NCT00973947

Customized Headrest or Standard Headrest in Holding Patients Still While Undergoing Radiation Therapy for Head and Neck Cancer

A Prospective Randomised Controlled Clinical Trial Investigating the Benefits of Patient-customised Headrests Versus Standard (Non-patient Specific) Headrests in the Immobilisation of Patients Receiving Radiotherapy for Head and Neck Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Cancer Trials Ireland · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Using a customized headrest to hold patients in one position may help doctors plan treatment for patients with head and neck cancer. It is not yet known whether a customized headrest is more effective than a standard headrest in holding patients still during radiation therapy. PURPOSE: This randomized clinical trial is studying a customized headrest to see how well it works compared with a standard headrest in holding patients still while undergoing radiation therapy for head and neck cancer.

Detailed description

OBJECTIVES: Primary * To evaluate and compare the treatment set-up accuracy of customized vs standard headrest in immobilizing patients undergoing radiotherapy for head and neck cancer. * To determine and compare patient comfort with the two immobilization techniques. Secondary * To evaluate radiation therapists' satisfaction with the two immobilization techniques. * To examine and compare the cost effectiveness of the two immobilization techniques. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 arms. * Arm I: Patients are immobilized using the standard thermoplastic four-point fixation mask and the standard headrest system. Patients undergo 3-dimensional conformal radiotherapy as per standard of care. * Arm II: Patients are immobilized using the standard thermoplastic four-point fixation mask and the customized headrest system. Patients undergo 3-dimensional conformal radiotherapy as per standard of care. Patients score their comfort using the Visual Analogue Scale during the course of radiotherapy. Radiation therapists complete an evaluation questionnaire for each treatment planning and procedure.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
OTHER	questionnaire administration
RADIATION	3-dimensional conformal radiation therapy
RADIATION	radiation therapy treatment planning/simulation

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2009-09-09
• Last updated: 2014-12-31

Locations

1 site across 1 country: Ireland