Head and Neck Cancer Clinical Trial
Official title:
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
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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