Comparing Closed Face Masks vs Surface Guided Radiation Therapy for Head and Neck Radiotherapy

NCT06870799 | Recruiting

• 2 other identifiers: RAO 24-0192025-D0007
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancers

Keywords

head and neck cancer; face mask; surface guidance; radiation therapy

Outcome Measures

Primary Outcomes (2)

• Patient discomfort, anxiety and pain

  Patients are asked to fill in a short questionnaire to rate their discomfort, anxiety and pain on a visual analogue scale ranging from 0 (=none) to 10 (=extreme)

  weekly from enrollment to end of treatment up to 7 weeks

• overall preference

  patients are asked to answer the question which treatment modality they preferred (with mask or without mask)

  once at end of treatment (max. 7 weeks)

Secondary Outcomes (4)

• Setup uncertainties

  during treatment before every treatment fraction, 5-6 times per week up to 7 weeks

• intra-fraction accuracy

  during treatment before every treatment fraction, 5-6 times per week up to 7 weeks

• Serious adverse events

  continuously during treatment up to 7 weeks

• Device Deficiencies of the surface guidance system

  continuously during treatment up to 7 weeks

Study Arms (2)

Closed Mask followed by No Mask

OTHER

The first half of the treatment is delivered with a face mask, the second half is delivered without mask using surface guidance only

Device: Surface guided radiation therapy; Device: Closed face mask

No Mask followed by Closed Mask

OTHER

The first half of the treatment is delivered without mask using surface guidance only, the second half is delivered with a face mask

Device: Surface guided radiation therapy; Device: Closed face mask

Interventions

Surface guided radiation therapy DEVICE

Radiation therapy will be delivered using no immobilization mask, but a surface guided system with infrared light

Closed Mask followed by No Mask; No Mask followed by Closed Mask

Closed face mask DEVICE

Radiotherapy with closed face mask for immobilization

Closed Mask followed by No Mask; No Mask followed by Closed Mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Panagiotis Balermpas, Prof. Dr.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katerina Nilo

CONTACT

+41 44 255 35 66; ina.nilo@usz.ch

Crystal Sulaiman

CONTACT

Crystal.Sulaiman@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 11, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)