Optical Surface Guidance for External Radiotherapy of Head and Neck Cancer (SUGAR)

Center Eugene Marquis

Status: Enrolling

Conditions: Otorhinolaryngeal Cancer

Treatments: Procedure: Surface Guided RadioTherapy (SGRT) without mask

Study type: Interventional

Funder types: Other

Identifiers

NCT06627075

2023-A02324-41 (Registry Identifier)

2023-4-74-003

Details and patient eligibility

About

The goal of this clinical trial is to test the use of surface repositioning alone, without a restraint mask, during radiotherapy sessions for patients with head and neck cancer.

Full description

In radiotherapy treatments for head and neck cancer, the use of a mask is recommended for patient immobilization. The mask completely covers the head and shoulders, ensuring reproducible positioning at every session. However, using a mask can be oppressive and anxiety-provoking for patients.

At the same time, technological developments have led us to use optical surface camera systems to position and monitor patients in the treatment room. In this way, if a movement exceeding the threshold is detected during a session, the treatment is automatically interrupted.

However, despite the use of the mask, movements are still possible underneath, and are not detected by the surface cameras.

The study's hypothesis is that the use of surface repositioning alone could guarantee reproducible treatment, as in combination with a thermoformed mask. In addition, eliminating the mask would mean greater comfort and improved quality of life for patients.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years of age
• Patients undergoing palliative or curative treatment for oro-rhino-laryngeal cancer
• Patients with an indication for radiotherapy treatment, with or without complementary treatment (chemotherapy, immunotherapy), with a number of sessions between 10 and 35
• Patients who have dated and signed an informed consent form

Exclusion criteria

• Patients with uncontrollable movements
• Patients under psychiatric care
• Patients who do not understand or read French
• Patients participating in an interventional study testing another medical intervention
• Patients under guardianship, curatorship, safeguard of justice or deprived of liberty
• Pregnant or breast-feeding women
• Patients without social security coverage

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Surface Guided RadioTherapy without face mask

Experimental group

Description:

Radiotherapy sessions will be carried out using the surface camera system, replacing the restraint mask. Self-assessment questionnaires will also be completed by healthcare professionals concerning the level of difficulty encountered during each SGRT session without mask. Skin side effects are recorded by the radiotherapist during weekly follow-up consultations. At the end of treatment, patients complete a patient experience questionnaire.

Treatment:

Procedure: Surface Guided RadioTherapy (SGRT) without mask