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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Receivi

Brief 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 Summary:

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.


Sponsor: Cancer Trials Ireland

Current Primary Outcome:

  • Treatment set-up accuracy [ Time Frame: 2010 ]
  • Patient comfort with the two immobilization techniques as assessed by a patient-scored Visual Analogue Scale [ Time Frame: 2010 ]


Original Primary Outcome:

  • Treatment set-up accuracy
  • Patient comfort with the two immobilization techniques as assessed by a patient-scored Visual Analogue Scale


Current Secondary Outcome:

  • Radiation therapists' satisfaction as assessed by a questionnaire [ Time Frame: 2010 ]
  • Cost-effectiveness as assessed by resource implications of the two immobilization techniques [ Time Frame: 2010 ]


Original Secondary Outcome:

  • Radiation therapists' satisfaction as assessed by a questionnaire
  • Cost-effectiveness as assessed by resource implications of the two immobilization techniques


Information By: Cancer Trials Ireland

Dates:
Date Received: September 5, 2009
Date Started: January 2008
Date Completion:
Last Updated: December 30, 2014
Last Verified: January 2013