Randomized Controlled Trial Comparing Closed Face Masks with Surface-Guided Radiation Therapy for Head and Neck Radiation Therapy
Summary description of the study
The study aims to investigate whether patient comfort and satisfaction can be improved with surface-guided radiation using an infrared light system. The mask commonly used in head and neck radiation will be omitted. The goal is to find an alternative to masks in radiation therapy, which is particularly relevant for patients with claustrophobia or other anxieties that may prevent them from receiving necessary treatment with a mask. The study is randomized, meaning patients are randomly assigned to one of two groups. In both groups, patients receive both radiation variants, half with a mask and half without a mask. One group will be irradiated with a mask first, while the other group will be irradiated without a mask first. The treatment will switch in the middle. Participation in the study lasts approximately 2 months for an individual patient (until the end of radiation therapy). During the study, patients will also be asked to complete questionnaires about their well-being.
(BASEC)
Intervention under investigation
Radiation therapy for head and neck cancer without a fixation mask, using a system that allows correct positioning through superficial infrared light. All patients receive both therapy variants, with and without a mask, for half of the treatment each. The order is switched in the middle and is randomized.
(BASEC)
Disease under investigation
Head and Neck Cancer
(BASEC)
- Head and neck cancer to be treated with radiation therapy
- 18 years or older
- Adequate self-care
(BASEC)
Exclusion criteria
- Previous radiation therapy in the head and neck area
- Pregnancy or breastfeeding
- Tumor located too close to the eyes or spine
(BASEC)
Trial sites
Zurich
(BASEC)
Sponsor
Universitätsspital Zürich
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Panagiotis Balermpas
+41 43 255 35 66
panagiotis.balermpas@clutterusz.chUniversitätsspital Zürich
(BASEC)
General Information
University of Zurich
+41 44 255 35 66
ina.nilo@usz.chpanagiotis.balermpas@clutterusz.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
15.04.2025
(BASEC)
ICTRP Trial ID
NCT06870799 (ICTRP)
Official title (approved by ethics committee)
Randomized controlled trial comparing closed face masks vs surface guided radiation therapy for head and neck radiotherapy (BASEC)
Academic title
Randomized Controlled Trial Comparing Closed Face Masks vs Surface Guided Radiation Therapy for Head and Neck Radiotherapy (ICTRP)
Public title
Comparing Closed Face Masks vs Surface Guided Radiation Therapy for Head and Neck Radiotherapy (ICTRP)
Disease under investigation
Head and Neck Cancers
(ICTRP)
Intervention under investigation
Device: Surface guided radiation therapyDevice: Closed face mask
(ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
(ICTRP)
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.
(ICTRP)
not available
Primary and secondary end points
Patient discomfort, anxiety and pain;overall preference
(ICTRP)
Setup uncertainties;intra-fraction accuracy;Serious adverse events;Device Deficiencies of the surface guidance system
(ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Panagiotis Balermpas, Prof. Dr.Katerina NiloPanagiotis Balermpas, Prof. Dr., ina.nilo@usz.chpanagiotis.balermpas@usz.ch, +41 44 255 35 66, University of Zurich (ICTRP)
Secondary trial IDs
2025-D0007, RAO 24-019 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/study/NCT06870799 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available