NCT04079595

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

December 9, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

May 23, 2024

Status Verified

May 1, 2024

Enrollment Period

2.2 years

First QC Date

July 11, 2019

Last Update Submit

May 22, 2024

Conditions

Brain TumorBrain MetastasesSmall Cell Lung CancerMeningioma

Outcome Measures

Primary Outcomes (2)

  • Patient discomfort with the two immobilization masks

    Patient discomfort measured with the Visual Analogue Scale (VAS) 0-10 with "no discomfort" (scored as 0) and "extreme discomfort" (scored as 10).

    Change in patient discomfort through the course of radiation therapy, up to 6 weeks

  • Mask preference

    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.

    At completion of radiation therapy, up to 6 weeks depending on radiation dose fractionation

Secondary Outcomes (4)

  • Treatment set-up accuracy

    Through the course of radiation therapy, up to 6 weeks

  • Treatment intra-fraction accuracy

    Through the course of radiation therapy, up to 6 weeks

  • Immobilization-mask-induced severe adverse events during treatment

    From the baseline to 3 months post-treatment

  • 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

Study Arms (2)

Open-faced head immonbilization masks

EXPERIMENTAL

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

Device: Head immobilization mask

Closed-face head immobilization masks

ACTIVE COMPARATOR

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

Device: Head immobilization mask

Interventions

Head immobilization maskDEVICE

Immobilization

Closed-face head immobilization masksOpen-faced head immonbilization masks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiation Oncology

Zurich, 8091, Switzerland

Location

Related Links

MeSH Terms

Conditions

Brain NeoplasmsSmall Cell Lung CarcinomaMeningioma

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasms, Vascular TissueMeningeal Neoplasms

Study Officials

  • Matthias Guckenberger, Dr.

    University Hospital Zurich, Department of Radiation Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2019

First Posted

September 6, 2019

Study Start

December 9, 2019

Primary Completion

February 28, 2022

Study Completion

May 31, 2022

Last Updated

May 23, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)