RecruitingPhase 3NCT06327139

Optimising Patient Experience in Head and Neck Radiotherapy

A Phase 3 Study Optimising Patient Experience in Head and Neck Radiotherapy


Sponsor

Irish Research Radiation Oncology Group

Enrollment

201 participants

Start Date

Jan 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a phase III, randomized, single-centre, multiple arm trial examining the set-up accuracy of three different types of immobilization methods for head and neck cancer patients receiving radical radiation therapy. The methods of immobilization under investigation in this study are two types of open faced head and neck masks compared with the convention closed faced head and neck mask. Patients receiving treatment using an open faced mask will have their intra fraction motion monitored through the use of intra fraction surface guided monitoring. The study aims to determine the set-up accuracy of the three types of immobilization through measuring the magnitude of the translational corrections on the daily cone beam computed tomography (CBCT). To be eligible for the study a patient must be planned to receive a minimum of 30 fractions of head and neck radiation therapy. Patients distress levels associated with each type of immobilization device will be measured using the psychological measure General Health Questionnaire-12 (GHQ-12) which will be collected at the beginning and end of their course of radiation therapy treatment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at ways to improve the experience of patients undergoing radiation therapy for head and neck cancer. Radiation to this area often requires a tight-fitting mask to keep the head still during treatment, which some patients find uncomfortable or distressing. Researchers are testing strategies to make this process more tolerable for patients. **You may be eligible if...** - You are 18 or older - You are receiving radical (curative) radiation therapy to the head and neck area over 30–35 sessions - You have provided written informed consent **You may NOT be eligible if...** - You or your doctor determines that you would not be able to tolerate a closed radiation mask during treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEConventional 5 point closed face immobilisation mask.

The conventional closed face mask is a standard of care immobilization device for head and neck cancer patients which covers and immobilizes the entire anterior portion of the patients head, neck and shoulders using a semi rigid thermoplastic material.

DEVICE5 point open face immobilization mask

The 5 point open face mask is a type of immobilization device for head and neck cancer patients which does not cover the patients face or chest. The device uses a semi rigid thermoplastic material and covers from the superior aspect of the patients head to the level of their clavicle.

DEVICE3 point open face immobilization mask

The 3 point open face mask is a type of immobilization device for head and neck cancer patients which does not cover the patients face. The device uses a semi rigid thermoplastic material and covers from the superior aspect of the patients head to the below the patients chin. The three point mask does not cover the patients shoulders and does not extend inferiorly to the level of the clavicle.


Locations(1)

St. Luke's Radiation Oncology Network

Dublin, Ireland

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NCT06327139


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