Comparing face masks and no masks for head and neck radiation therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the use of closed face masks versus no masks in patients undergoing radiation therapy for head and neck cancers. Patients will be randomly assigned to receive treatment with either an immobilization mask or without one, allowing for an assessment of comfort, anxiety, and setup accuracy. The study will document positioning setup information and patient feedback through questionnaires to evaluate their experience during treatment. The goal is to determine if eliminating the mask improves patient comfort without compromising treatment effectiveness.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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;
* Patients who are willing and able to comply with scheduled visits, treatment, and other trial procedures.

Exclusion Criteria:

* 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;
* Known or suspected non-compliance, drug or alcohol abuse;
* Inability to follow the procedures of the trial, e.g. due to language problems of the participant;
* Enrolment of the investigator, his/her family members, employees and other dependent persons.
* One of the following Tumor Types: Nasopharynx, Sinunasal, patients with CTV within 5 mm of eyes or spinal cord.

Where it's running

• University Hospital Zurich
  Zurich, Switzerland Recruiting

Study contacts

• Principal investigator: Panagiotis Balermpas, Prof. Dr. — University of Zurich
• Study coordinator: Katerina Nilo
• Email: ina.nilo@usz.ch
• Phone: +41 44 255 35 66

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.