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.

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

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.

questionnaire administration

3-dimensional conformal radiation therapy

radiation therapy treatment planning/simulation

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

Immobilisation: Standard headrest plus individual customised mask (orfit)

Immobilisation: Customised headrest plus individual customised mask (orfit)

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the Participation Requirements?