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The aim of the study is to evaluate whether open-face masks improve patient comfort/preference whilst maintaining immobilization performance as known for closed masks in patients undergoing whole or partial cranial radiotherapy.
Upon randomization, patients will be begin treatment either with an open-face mask (A) or closed mask (B). Two individual immobilization masks - the open-face and closed masks - will be fabricated for every single patient. During the 1st half of treatment the randomly assigned mask will be used followed by using another mask for the 2nd half of treatment. Discomfort/pain/anxiety and mask preference will be scored during treatment with a questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-faced head immonbilization masks | Experimental | Masks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with openings for the face |
|
| Closed-face head immobilization masks | Active Comparator | Masks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with the face closed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Head immobilization mask | Device | Immobilization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient discomfort with the two immobilization masks | Patient discomfort measured with the Visual Analogue Scale (VAS) 0-10 with "no discomfort" (scored as 0) and "extreme discomfort" (scored as 10). | Change in patient discomfort through the course of radiation therapy, up to 6 weeks |
| Mask preference | Mask preference measured with the Yes/No questionnaire. Upon completion of radiation therapy patients will be asked which of the two immobilization masks they prefer - either Yes or No to one of the used masks. | At completion of radiation therapy, up to 6 weeks depending on radiation dose fractionation |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment set-up accuracy | Measured with planar kilovoltage (kV) imaging | Through the course of radiation therapy, up to 6 weeks |
| Treatment intra-fraction accuracy | Measured with an optic surface imaging (OSI) system |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Guckenberger, Dr. | University Hospital Zurich, Department of Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology | Zurich | 8091 | Switzerland |
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| Label | URL |
|---|---|
| Randomized self-controlled study comparing open-face vs. closed immobilization masks in fractionated cranial radiotherapy | View source |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| D008579 | Meningioma |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Through the course of radiation therapy, up to 6 weeks |
| Immobilization-mask-induced severe adverse events during treatment | Measured with CTCAE version 5.0 | From the baseline to 3 months post-treatment |
| Location of discomfort on the head/face | Measured with the questionnaire consisting of a head/face diagram divided in 8 regions | Changes in location of discomfort on the head/face through the course of radiation therapy up to 6 weeks |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |