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Closed vs. Open Face Masks for Cranial Radiotherapy

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ClinicalTrials.gov Identifier: NCT04079595
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Brain Tumor Brain Metastases Small Cell Lung Cancer Meningioma Device: Head immobilization mask Not Applicable

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Randomized Controlled Trial Comparing Closed vs. Open Face Masks for Cranial Radiotherapy
Actual Study Start Date : December 9, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Open-faced head immonbilization masks
Masks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with openings for the face
Device: Head immobilization mask
Immobilization

Active Comparator: Closed-face head immobilization masks
Masks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with the face closed
Device: Head immobilization mask
Immobilization




Primary Outcome Measures :
  1. Patient discomfort with the two immobilization masks [ Time Frame: Change in patient discomfort through the course of radiation therapy, up to 6 weeks ]
    Patient discomfort measured with the Visual Analogue Scale (VAS) 0-10 with "no discomfort" (scored as 0) and "extreme discomfort" (scored as 10).

  2. Mask preference [ Time Frame: At completion of radiation therapy, up to 6 weeks depending on radiation dose fractionation ]
    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.


Secondary Outcome Measures :
  1. Treatment set-up accuracy [ Time Frame: Through the course of radiation therapy, up to 6 weeks ]
    Measured with planar kilovoltage (kV) imaging

  2. Treatment intra-fraction accuracy [ Time Frame: Through the course of radiation therapy, up to 6 weeks ]
    Measured with an optic surface imaging (OSI) system

  3. Immobilization-mask-induced severe adverse events during treatment [ Time Frame: From the baseline to 3 months post-treatment ]
    Measured with CTCAE version 5.0

  4. Location of discomfort on the head/face [ Time Frame: Changes in location of discomfort on the head/face through the course of radiation therapy up to 6 weeks ]
    Measured with the questionnaire consisting of a head/face diagram divided in 8 regions



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent according to Swiss law and International Council for Harmonization (ICH)/Good Clinical Practice (GCP) regulations before any trial specific procedures;
  • Indication for cranial radiotherapy irrespective of tumor type;
  • Age: ≥ 18 years old;
  • Karnofsky performance status ≥70;
  • Patients who are willing and able to comply with scheduled visits, treatment, and other trial procedures.

Exclusion Criteria:

  • Cranial radiotherapy in less than 10 fractions;
  • Prior brain irradiation;
  • Inability to complete magnetic resonance imaging (MRI) procedure due to claustrophobic anxiety;
  • Women who are pregnant or breast feeding;
  • Intention to become pregnant during the course of the trial;
  • Lack of safe contraception;
  • Known or suspected non-compliance, drug or alcohol abuse

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): NCT04079595


Contacts
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Contact: Matthias Guckenberger, Dr. +41 44 255 29 30 matthias.guckenberger@usz.ch

Locations
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Switzerland
Department of Radiation Oncology Recruiting
Zürich, Switzerland, 8091
Contact: Michelle Brown, Dr.    +41 44 255 35 67    michelleleanne.brown@usz.ch   
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Matthias Guckenberger, Dr. University Hospital Zurich, Department of Radiation Oncology
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04079595    
Other Study ID Numbers: Comfort RCT
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Small Cell Lung Carcinoma
Brain Neoplasms
Meningioma
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Meningeal Neoplasms