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

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Other: questionnaire administration; Radiation: 3-dimensional conformal radiation therapy; Radiation: radiation therapy treatment planning/simulation

• Registration Number: NCT00973947
• Lead Sponsor: Cancer Trials Ireland

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 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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-09-05
• Study First Submitted QC: 2009-09-05
• Study First Posted: 2009-09-09
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2013-01
• Last Update Submitted: 2014-12-30
• Last Update Posted: 2014-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	3-dimensional conformal radiation therapy	Immobilisation: Standard headrest plus individual customised mask (orfit)
TRial Arm	3-dimensional conformal radiation therapy	Immobilisation: Customised headrest plus individual customised mask (orfit)
Control	radiation therapy treatment planning/simulation	Immobilisation: Standard headrest plus individual customised mask (orfit)
TRial Arm	questionnaire administration	Immobilisation: Customised headrest plus individual customised mask (orfit)
Control	questionnaire administration	Immobilisation: Standard headrest plus individual customised mask (orfit)
TRial Arm	radiation therapy treatment planning/simulation	Immobilisation: Customised headrest plus individual customised mask (orfit)

Primary Outcome Measures

Name	Time	Method
Treatment set-up accuracy	2010
Patient comfort with the two immobilization techniques as assessed by a patient-scored Visual Analogue Scale	2010

Secondary Outcome Measures

Name	Time	Method
Radiation therapists' satisfaction as assessed by a questionnaire	2010
Cost-effectiveness as assessed by resource implications of the two immobilization techniques	2010

Trial Locations

Locations (1)

Saint Luke's Hospital; 🇮🇪 Dublin, Ireland