Randomized Controlled Trial Comparing Closed vs. Open Face Masks for Cranial Radiotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Zurich
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Patient discomfort with the two immobilization masks
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Head immobilization mask (Device)
Closed-face head immobilization masks
Masks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with the face closed
Intervention: Head immobilization mask (Device)
Outcomes
Primary Outcomes
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).
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
- Immobilization-mask-induced severe adverse events during treatment(From the baseline to 3 months post-treatment)
- Treatment intra-fraction accuracy(Through the course of radiation therapy, up to 6 weeks)
- Treatment set-up accuracy(Through the course of radiation therapy, up to 6 weeks)
- Location of discomfort on the head/face(Changes in location of discomfort on the head/face through the course of radiation therapy up to 6 weeks)