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OpenTrials
Completed

NCT Number: NCT00973947

Customized Headrest or Standard Headrest in Holding Patients Still While Undergoing Radiation Therapy 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Histologically confirmed head and neck malignancy
  • Planning to undergo radical 3-dimensional conformal radiotherapy (using the Oncentra MasterPlan treatment planning system) at St Luke's Hospital

PATIENT CHARACTERISTICS:

  • No evidence of any other significant clinical disorder or laboratory finding that would make it undesirable for the patient to participate in the study
  • Able to comply with the study, in the opinion of the researcher and/or medical team

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Treatment and study plan

Questionnaire Administration

Other

3-Dimensional Conformal Radiation Therapy

Radiation

radiation therapy treatment planning/simulation

Radiation

Primary outcomes

  1. Treatment set-up accuracy

    Time frame: 2010

  2. Patient comfort with the two immobilization techniques as assessed by a patient-scored Visual Analogue Scale

    Time frame: 2010

Secondary outcomes

  1. Radiation therapists' satisfaction as assessed by a questionnaire

    Time frame: 2010

  2. Cost-effectiveness as assessed by resource implications of the two immobilization techniques

    Time frame: 2010

Sponsors and collaborators

Lead sponsor

Cancer Trials Ireland

Network

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 9, 2009
Registry last updated
Dec 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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