Comparing face masks and no masks for head and neck radiation therapy
Randomized Controlled Trial Comparing Closed Face Masks vs Surface Guided Radiation Therapy for Head and Neck Radiotherapy
This study tests whether using a face mask during radiation therapy for head and neck cancer makes patients feel more comfortable and less anxious compared to not using a mask.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Zurich) |
| Trial ID | NCT06870799 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require head and neck radiotherapy and have a Karnofsky performance status of 70 or higher.
Not a fit: Patients who have previously undergone head and neck irradiation or are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient comfort during radiation therapy for head and neck cancers.
How similar studies have performed: While feasibility trials have explored this topic, this randomized clinical trial approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Zurich
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.