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Completed

NCT Number: NCT04079595

Closed vs. Open Face Masks for Cranial Radiotherapy

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.

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Key information

Conditions

Brain Tumor Brain Diseases Brain Metastases Brain Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Central Nervous System Diseases Central Nervous System Neoplasms Lung Diseases Lung Neoplasms Meningeal Neoplasms Meningioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Nerve Tissue Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Cancer Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Radiation Oncology

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Head immobilization mask

Device

Immobilization

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Randomized Controlled Trial Comparing Closed vs. Open Face Masks for Cranial Radiotherapy

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 6, 2019
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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