Randomized Controlled Trial Comparing Closed Face Masks with Surface-Guided Radiation Therapy for Head and Neck Radiation Therapy
Résumé de l'étude
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 étudiée
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)
Maladie en cours d'investigation
Head and Neck Cancer
(BASEC)
- Head and neck cancer to be treated with radiation therapy
- 18 years or older
- Adequate self-care
(BASEC)
Critères d'exclusion
- Previous radiation therapy in the head and neck area
- Pregnancy or breastfeeding
- Tumor located too close to the eyes or spine
(BASEC)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
Universitätsspital Zürich
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Dr. med. Panagiotis Balermpas
+41 43 255 35 66
panagiotis.balermpas@clutterusz.chUniversitätsspital Zürich
(BASEC)
Informations générales
University of Zurich
+41 44 255 35 66
ina.nilo@usz.chpanagiotis.balermpas@clutterusz.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
15.04.2025
(BASEC)
Identifiant de l'essai ICTRP
NCT06870799 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Randomized controlled trial comparing closed face masks vs surface guided radiation therapy for head and neck radiotherapy (BASEC)
Titre académique
Randomized Controlled Trial Comparing Closed Face Masks vs Surface Guided Radiation Therapy for Head and Neck Radiotherapy (ICTRP)
Titre public
Comparing Closed Face Masks vs Surface Guided Radiation Therapy for Head and Neck Radiotherapy (ICTRP)
Maladie en cours d'investigation
Head and Neck Cancers
(ICTRP)
Intervention étudiée
Device: Surface guided radiation therapyDevice: Closed face mask
(ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
(ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
Patient discomfort, anxiety and pain;overall preference
(ICTRP)
Setup uncertainties;intra-fraction accuracy;Serious adverse events;Device Deficiencies of the surface guidance system
(ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
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 secondaires
2025-D0007, RAO 24-019 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/study/NCT06870799 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible