Randomized Controlled Trial Comparing Closed Face Masks with Surface-Guided Radiation Therapy for Head and Neck Radiation Therapy
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
Head and Neck Cancer
(BASEC)
- Head and neck cancer to be treated with radiation therapy
- 18 years or older
- Adequate self-care
(BASEC)
Criteri di esclusione
- Previous radiation therapy in the head and neck area
- Pregnancy or breastfeeding
- Tumor located too close to the eyes or spine
(BASEC)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
Universitätsspital Zürich
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. med. Panagiotis Balermpas
+41 43 255 35 66
panagiotis.balermpas@clutterusz.chUniversitätsspital Zürich
(BASEC)
Informazioni generali
University of Zurich
+41 44 255 35 66
ina.nilo@usz.chpanagiotis.balermpas@clutterusz.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
15.04.2025
(BASEC)
ID di studio ICTRP
NCT06870799 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Randomized controlled trial comparing closed face masks vs surface guided radiation therapy for head and neck radiotherapy (BASEC)
Titolo accademico
Randomized Controlled Trial Comparing Closed Face Masks vs Surface Guided Radiation Therapy for Head and Neck Radiotherapy (ICTRP)
Titolo pubblico
Comparing Closed Face Masks vs Surface Guided Radiation Therapy for Head and Neck Radiotherapy (ICTRP)
Malattie studiate
Head and Neck Cancers
(ICTRP)
Intervento studiato
Device: Surface guided radiation therapyDevice: Closed face mask
(ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
(ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
Patient discomfort, anxiety and pain;overall preference
(ICTRP)
Setup uncertainties;intra-fraction accuracy;Serious adverse events;Device Deficiencies of the surface guidance system
(ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
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)
ID secondari
2025-D0007, RAO 24-019 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT06870799 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile