Optimising Patient Experience in Head and Neck Radiotherapy

NCT06327139 | Recruiting Phase 3 DMC

• 1 other identifier: CTRIAL 23-24
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer

Keywords

Radiation Therapy; Set-up Accuracy; Faceless Mask; Immobilisation; Quality of Life

Outcome Measures

Primary Outcomes (1)

• The setup accuracy of each immobilization device will be measured based on the magnitude of the translational corrections measured in millimeters prior to delivery of each radiation therapy fraction.

  The vertical, lateral and longitudinal translational corrections are measured in millimeters on the daily pre treatment CBCT. The magnitude of this translational correction will be measured for every fraction of radiation therapy and used as a measurement of the set up accuracy of each type of immobilization device under investigation. The mean (M) and standard deviation (SD) of the corrections of the three arms in the translational direction will be analyzed, using Independent t-test and Mann-Whitney U test

  21 months

Secondary Outcomes (1)

• Estimate of distress levels during the first week and during the final week of the participants course of radiation therapy using the psychological measure General Health Questionnaire-12 (GHQ-12).

  21 months

Study Arms (3)

Arm One: Conventional 5 point closed face immobilisation mask.

ACTIVE COMPARATOR

Participants will be immobilized using the standard of care immobilization for patients receiving radical radiation therapy to the head and neck which is a five point closed face mask. The thermoplastic mask immobilizes the patients head, neck and shoulders fully. Participants randomized to this group will not be monitored using intra fraction surface guided monitoring.

Device: Conventional 5 point closed face immobilisation mask.

Arm Two: 5 point open face immobilization mask

EXPERIMENTAL

Participants will be immobilized using the 5 point open face immobilization mask. The thermoplastic mask immobilizes the participants head, neck and shoulders however the mask does not cover the patients anterior portion of the participants face or chest Participants randomized to this group will be monitored using intra fraction surface guided monitoring.

Device: 5 point open face immobilization mask

Arm Three: 3 point open face immobilization mask

EXPERIMENTAL

Participants will be immobilized using the 3 point open face immobilization mask. The thermoplastic mask immobilizes the patients head only and does not cover the participants face. Participants randomized to this group will be monitored using intra fraction surface guided monitoring.

Device: 3 point open face immobilization mask

Interventions

Conventional 5 point closed face immobilisation mask. DEVICE

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.

Arm One: Conventional 5 point closed face immobilisation mask.

5 point open face immobilization mask DEVICE

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.

Also known as: The open face mask is a type of immobilization device for head and neck cancer patients which does not cover the patients face or chest.

Arm Two: 5 point open face immobilization mask

3 point open face immobilization mask DEVICE

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.

Arm Three: 3 point open face immobilization mask

Eligibility Criteria

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

You may qualify if:

• All radical H\&N patients receiving 30-35 fractions of Radiotherapy
• Written informed consent obtained prior to any study-specific procedures
• ≥18 years of age

You may not qualify if:

• \) Patient who from the outset who would not tolerate or would be unable to proceed with treatment if placed in a closed mask, at the discretion of either the patient or the clinician.

Sponsors & Collaborators

• Irish Research Radiation Oncology Group: lead

Study Sites (1)

St. Luke's Radiation Oncology Network

Dublin, D06 HH36, Ireland

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Roisin O Maolalai

CONTACT

0035314065000; Roisin.OMaolalai@slh.ie

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This study is a phase III, randomized, single-centre, multiple arm trial of immobilization methods for head and neck cancer patients receiving radical radiation therapy. A faceless three point head and neck mask in conjunction with intra fraction surface guided monitoring, a faceless five point mask in conjunction with intra fraction surface guided monitoring and a conventional closed face five point mask without the use of intra fraction surface guided monitoring are being investigated in this study. The set-up accuracy will be based on the magnitude of the translational corrections measured prior to delivery of each radiation therapy fraction.

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: March 25, 2024
• Study Start: January 2, 2024
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)