Randomized Controlled Trial Comparing Closed Face Masks with Surface-Guided Radiation Therapy for Head and Neck Radiation Therapy
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
Head and Neck Cancer
(BASEC)
- Head and neck cancer to be treated with radiation therapy
- 18 years or older
- Adequate self-care
(BASEC)
Ausschlusskriterien
- Previous radiation therapy in the head and neck area
- Pregnancy or breastfeeding
- Tumor located too close to the eyes or spine
(BASEC)
Studienstandort
Zürich
(BASEC)
Sponsor
Universitätsspital Zürich
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. med. Panagiotis Balermpas
+41 43 255 35 66
panagiotis.balermpas@clutterusz.chUniversitätsspital Zürich
(BASEC)
Allgemeine Auskünfte
University of Zurich
+41 44 255 35 66
ina.nilo@usz.chpanagiotis.balermpas@clutterusz.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
15.04.2025
(BASEC)
ICTRP Studien-ID
NCT06870799 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Randomized controlled trial comparing closed face masks vs surface guided radiation therapy for head and neck radiotherapy (BASEC)
Wissenschaftlicher Titel
Randomized Controlled Trial Comparing Closed Face Masks vs Surface Guided Radiation Therapy for Head and Neck Radiotherapy (ICTRP)
Öffentlicher Titel
Comparing Closed Face Masks vs Surface Guided Radiation Therapy for Head and Neck Radiotherapy (ICTRP)
Untersuchte Krankheit(en)
Head and Neck Cancers
(ICTRP)
Untersuchte Intervention
Device: Surface guided radiation therapyDevice: Closed face mask
(ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
(ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
Patient discomfort, anxiety and pain;overall preference
(ICTRP)
Setup uncertainties;intra-fraction accuracy;Serious adverse events;Device Deficiencies of the surface guidance system
(ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
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)
Sekundäre IDs
2025-D0007, RAO 24-019 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT06870799 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar