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Comparing Closed Face Masks vs Surface Guided Radiation Therapy for Head and Neck Radiotherapy

ConditionHead and Neck Cancers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Zurich

About this trial

At present, open-face masks are used only in patients with claustrophobic anxiety, while all other patients are still immobilized with closed masks, thereby overlooking the need for improvement in patient comfort. Closed face masks in patients undergoing head and neck irradiation have never been compared to no masks in the setting of a randomized clinical trial, but only in feasibility trials. A randomized clinical trial may establish the role of no masks in terms of patient comfort, preference and setup accuracy in all patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent according to Swiss law and ICH/GCP regulations before any trial specific procedures;

Indication for head and neck radiotherapy irrespective of tumor type;

Age: ≥ 18 years old;

Karnofsky performance status ≥70;

Disqualifiers

Prior head and neck irradiation;

Women who are pregnant or breast feeding;

Intention to become pregnant during the course of the trial;

Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases;

Trial design

Design model

Crossover

Treatments tested in this trial

  • Surface guided radiation therapy

    Device

    Radiation therapy will be delivered using no immobilization mask, but a surface guided system with infrared light

  • Closed face mask

    Device

    Radiotherapy with closed face mask for immobilization

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Closed Mask followed by No MaskOther 2 interventions
Group B: No Mask followed by Closed MaskOther 2 interventions

Trial outcomes

Primary outcomes

1

Patient discomfort, anxiety and pain

Patients are asked to fill in a short questionnaire to rate their discomfort, anxiety and pain on a visual analogue scale ranging from 0 (=none) to 10 (=extreme)

Time frame
weekly from enrollment to end of treatment up to 7 weeks
2

overall preference

patients are asked to answer the question which treatment modality they preferred (with mask or without mask)

Time frame
once at end of treatment (max. 7 weeks)

Secondary outcomes

1

Setup uncertainties

inter-fraction accuracy is measured with CBCT imaging

Time frame
during treatment before every treatment fraction, 5-6 times per week up to 7 weeks
2

intra-fraction accuracy

intra-fraction accuracy is measured with planar CBCT imaging and an optic surface imaging system

Time frame
during treatment before every treatment fraction, 5-6 times per week up to 7 weeks
3

Serious adverse events

mask-induced and no-mask-induced events will be recorded during treatment

Time frame
continuously during treatment up to 7 weeks
4

Device Deficiencies of the surface guidance system

Device Deficiencies of the surface guidance system are recorded

Time frame
continuously during treatment up to 7 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Zurich

Lead sponsor

Source ClinicalTrials.gov
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