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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973947
• Other study ID #: 08-09 ICORG
• Secondary ID: ICORG-08-09EU-20
• Status: Completed
• Phase: N/A
• First received: September 5, 2009
• Last updated: December 30, 2014
• Start date: January 2008
• Est. completion date: August 2010

Study information

• Verified date: January 2013
• Source: ICORG- All Ireland Cooperative Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• questionnaire administration

Radiation:
• 3-dimensional conformal radiation therapy

• radiation therapy treatment planning/simulation

Locations

Country	Name	City	State
Ireland	Saint Luke's Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
ICORG- All Ireland Cooperative Oncology Research Group

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment set-up accuracy		2010	No
Primary	Patient comfort with the two immobilization techniques as assessed by a patient-scored Visual Analogue Scale		2010	No
Secondary	Radiation therapists' satisfaction as assessed by a questionnaire		2010	No
Secondary	Cost-effectiveness as assessed by resource implications of the two immobilization techniques		2010	No