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

Cancer Trials Ireland

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Radiation: 3-dimensional conformal radiation therapy; Other: questionnaire administration; Radiation: radiation therapy treatment planning/simulation

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00973947

08-09 ICORG

ICORG-08-09

EU-20954

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Control

Other group

Description:

Immobilisation: Standard headrest plus individual customised mask (orfit)

Treatment:

Radiation: radiation therapy treatment planning/simulation

Other: questionnaire administration

Radiation: 3-dimensional conformal radiation therapy

TRial Arm

Other group

Description:

Immobilisation: Customised headrest plus individual customised mask (orfit)

Treatment:

Radiation: radiation therapy treatment planning/simulation

Other: questionnaire administration

Radiation: 3-dimensional conformal radiation therapy