NCT06870799 Comparing Closed Face Masks vs Surface Guided Radiation Therapy for Head and Neck Radiotherapy
| NCT ID | NCT06870799 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Zurich |
| Condition | Head and Neck Cancers |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-05-12 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2025-05-12 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Panagiotis Balermpas, Prof. Dr.
PRINCIPAL INVESTIGATOR
University of Zurich
Frequently Asked Questions
Who can join the NCT06870799 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06870799 currently recruiting?
Yes, NCT06870799 is actively recruiting participants. Contact the research team at ina.nilo@usz.ch for enrollment information.
Where is the NCT06870799 trial being conducted?
This trial is being conducted at Zurich, Switzerland.
Who is sponsoring the NCT06870799 clinical trial?
NCT06870799 is sponsored by University of Zurich. The principal investigator is Panagiotis Balermpas, Prof. Dr. at University of Zurich. The trial plans to enroll 25 participants.
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