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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00973947
First Posted: September 9, 2009
Last Update Posted: December 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cancer Trials Ireland
  Purpose

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.


Condition Intervention
Head and Neck Cancer Other: questionnaire administration Radiation: 3-dimensional conformal radiation therapy Radiation: radiation therapy treatment planning/simulation

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

Resource links provided by NLM:


Further study details as provided by Cancer Trials Ireland:

Primary Outcome Measures:
  • Treatment set-up accuracy [ Time Frame: 2010 ]
  • Patient comfort with the two immobilization techniques as assessed by a patient-scored Visual Analogue Scale [ Time Frame: 2010 ]

Secondary Outcome Measures:
  • Radiation therapists' satisfaction as assessed by a questionnaire [ Time Frame: 2010 ]
  • Cost-effectiveness as assessed by resource implications of the two immobilization techniques [ Time Frame: 2010 ]

Enrollment: 40
Study Start Date: January 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control
Immobilisation: Standard headrest plus individual customised mask (orfit)
Other: questionnaire administration Radiation: 3-dimensional conformal radiation therapy Radiation: radiation therapy treatment planning/simulation
TRial Arm
Immobilisation: Customised headrest plus individual customised mask (orfit)
Other: questionnaire administration Radiation: 3-dimensional conformal radiation therapy Radiation: radiation therapy treatment planning/simulation

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00973947


Locations
Ireland
Saint Luke's Hospital
Dublin, Ireland, 6
Sponsors and Collaborators
Cancer Trials Ireland
Investigators
Principal Investigator: Pierre Thirion, MD Saint Luke's Hospital
  More Information

Responsible Party: Cancer Trials Ireland
ClinicalTrials.gov Identifier: NCT00973947     History of Changes
Other Study ID Numbers: 08-09 ICORG
ICORG-08-09
EU-20954
First Submitted: September 5, 2009
First Posted: September 9, 2009
Last Update Posted: December 31, 2014
Last Verified: January 2013

Keywords provided by Cancer Trials Ireland:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms