Closed vs. Open Face Masks for Cranial Radiotherapy

University of Zurich (UZH)

Status: Completed

Conditions: Brain Metastases; Meningioma; Small Cell Lung Cancer; Brain Tumor

Treatments: Device: Head immobilization mask

Study type: Interventional

Funder types: Other

Identifiers

NCT04079595

Comfort RCT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Open-faced head immonbilization masks

Experimental group

Description:

Masks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with openings for the face

Treatment:

Device: Head immobilization mask

Closed-face head immobilization masks

Active Comparator group

Description:

Masks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with the face closed

Treatment:

Device: Head immobilization mask