Clinical trial NCT04079595: Closed vs. Open Face Masks for Cranial Radiotherapy
Official title: Randomized Controlled Trial Comparing Closed vs. Open Face Masks for Cranial Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Tumor
Brain Metastases
Small Cell Lung Cancer
Meningioma
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Patient discomfort with the two immobilization masks
timeFrame: Change in patient discomfort through the course of radiation therapy, up to 6 weeks
measure: Mask preference
timeFrame: At completion of radiation therapy, up to 6 weeks depending on radiation dose fractionation
Secondary outcomes:
measure: Treatment set-up accuracy
timeFrame: Through the course of radiation therapy, up to 6 weeks
measure: Treatment intra-fraction accuracy
timeFrame: Through the course of radiation therapy, up to 6 weeks
measure: Immobilization-mask-induced severe adverse events during treatment
timeFrame: From the baseline to 3 months post-treatment
measure: Location of discomfort on the head/face
timeFrame: Changes in location of discomfort on the head/face through the course of radiation therapy up to 6 weeks
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Department of Radiation Oncology
Study officials:
affiliation: University Hospital Zurich, Department of Radiation Oncology
name: Matthias Guckenberger, Dr.
role: PRINCIPAL_INVESTIGATOR
References: