Closed vs. Open Face Masks for Cranial Radiotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-09

Study Completion Date

2022-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing Immobilisation Shells in Cranial Radiotherapy

NCT02599142

Brain Metastases Bone Metastases Brain Tumor, Primary +2 more

COMPLETED NA

Optimising Patient Experience in Head and Neck Radiotherapy

NCT06327139

Head and Neck Cancer

RECRUITING PHASE3

Masks Against Surface-Scanning for Radiation Therapy Immobilisation in Head and Neck Cancer (MASSC)

NCT05011500

Head and Neck Neoplasm

UNKNOWN NA

Acquisition of 3D Facial Geometry of Patients' Scheduled for Radiotherapy Treatment

NCT02930915

Head and Neck Cancer

UNKNOWN

Intrafractional Head Movement During Radiosurgery

NCT03896555

Brain Metastases, Adult

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Brain Tumor Brain Metastases Small Cell Lung Cancer Meningioma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Head immobilization mask

Intervention Type DEVICE

Immobilization

Closed-face head immobilization masks

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

Group Type ACTIVE_COMPARATOR

Head immobilization mask

Intervention Type DEVICE

Immobilization

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Head immobilization mask

Immobilization

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No