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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Other: questionnaire administration
* Radiation: 3-dimensional conformal radiation therapy
* Radiation: radiation therapy treatment planning/simulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>Immobilisation: Standard headrest plus individual customised mask (orfit) | Other: questionnaire administration<br> <br> Radiation: 3-dimensional conformal radiation therapy<br> <br> Radiation: radiation therapy treatment planning/simulation<br> <br> |
| Other: TRial Arm<br>Immobilisation: Customised headrest plus individual customised mask (orfit) | Other: questionnaire administration<br> <br> Radiation: 3-dimensional conformal radiation therapy<br> <br> Radiation: radiation therapy treatment planning/simulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation therapists' satisfaction as assessed by a questionnaire |  | 2010 | 
| Cost-effectiveness as assessed by resource implications of the two immobilization techniques |  | 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage I verrucous carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage II verrucous carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage III verrucous carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, stage I adenoid cystic carcinoma of the oral cavity, stage I mucoepidermoid carcinoma of the oral cavity, stage I verrucous carcinoma of the oral cavity, stage II adenoid cystic carcinoma of the oral cavity, stage II mucoepidermoid carcinoma of the oral cavity, stage II verrucous carcinoma of the oral cavity, stage III adenoid cystic carcinoma of the oral cavity, stage III mucoepidermoid carcinoma of the oral cavity, stage III verrucous carcinoma of the oral cavity, stage IV adenoid cystic carcinoma of the oral cavity, stage IV mucoepidermoid carcinoma of the oral cavity, stage IV verrucous carcinoma of the oral cavity, stage I squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage I basal cell carcinoma of the lip, stage II basal cell carcinoma of the lip, stage III basal cell carcinoma of the lip, stage IV basal cell carcinoma of the lip, metastatic squamous neck cancer with occult primary squamous cell carcinoma, untreated metastatic squamous neck cancer with occult primary, stage I lymphoepithelioma of the nasopharynx, stage I squamous cell carcinoma of the nasopharynx, stage II lymphoepithelioma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx, stage III lymphoepithelioma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, stage I lymphoepithelioma of the oropharynx, stage I squamous cell carcinoma of the oropharynx, stage II lymphoepithelioma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage III lymphoepithelioma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV lymphoepithelioma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage I inverted papilloma of the paranasal sinus and nasal cavity, stage I midline lethal granuloma of the paranasal sinus and nasal cavity, stage I squamous cell carcinoma of the paranasal sinus and nasal cavity, stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage II inverted papilloma of the paranasal sinus and nasal cavity, stage II midline lethal granuloma of the paranasal sinus and nasal cavity, stage II squamous cell carcinoma of the paranasal sinus and nasal cavity, stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage III inverted papilloma of the paranasal sinus and nasal cavity, stage III midline lethal granuloma of the paranasal sinus and nasal cavity, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage IV inverted papilloma of the paranasal sinus and nasal cavity, stage IV midline lethal granuloma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, stage I salivary gland cancer, stage II salivary gland cancer, stage III salivary gland cancer, stage IV salivary gland cancer, recurrent lymphoepithelioma of the nasopharynx, recurrent lymphoepithelioma of the oropharynx, recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the larynx, recurrent verrucous carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent basal cell carcinoma of the lip, recurrent adenoid cystic carcinoma of the oral cavity, recurrent mucoepidermoid carcinoma of the oral cavity, recurrent verrucous carcinoma of the oral cavity, recurrent metastatic squamous neck cancer with occult primary, recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity, recurrent inverted papilloma of the paranasal sinus and nasal cavity, recurrent midline lethal granuloma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent salivary gland cancer