Optimising Patient Experience in Head and Neck Radiotherapy

Head and Neck Cancer Clinical Trial

— OPEN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06327139
• Other study ID #: CTRIAL 23-24
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2, 2024
• Est. completion date: July 2025

Study information

• Verified date: March 2024
• Source: Irish Research Radiation Oncology Group
• Contact: Roisin O Maolalai
• Phone: 0035314065000
• Email: Roisin.OMaolalai[@]slh.ie
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

The two types of immobilization under investigation consist of a faceless three point head and neck mask in conjunction with intra fraction surface guided monitoring and a faceless five point mask in conjunction with intra fraction surface guided monitoring.

The standard of care immobilization consists of a conventional closed face five point mask without the use of intra fraction surface guided monitoring. .

The primary aim of this study is to determine the set-up accuracy of the two types of faceless mask compared with the conventional closed face mask. The set-up accuracy will be measured based on the magnitude of the translational corrections measured prior to delivery of each radiation therapy fraction. This will be measured in millimeters on the daily CBCT.

The secondary aim of this study is to determine the level of distress associated with each type of immobilization device.

A total of 198 evaluable patients will be required for the study. The sample size was calculated based on power calculations to detect clinically significant differences in setup accuracy and patient experience across the three arms.

The enrollment period is expected to be 1 year.

Translational corrections will be measured prior to each fraction of radiation therapy delivered and a minimum of 30 fractions must be delivered in order for a patient to be considered evaluable on trial. The open faced masks will be considered equivalent to the standard of care closed faced mask in terms of set-up accuracy if the difference in translational corrections across the three groups does not indicate a necessity for an increase in the planning target volume for patients planned for radiation therapy treatment using an open faced mask.

Level's of distress will be measured using the psychological measure General Health Questionnaire-12 (GHQ-12). The open faced masks will be considered equivalent to the standard of care closed faced mask the difference in level's of distress between groups does not meet the significance level 0.5.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 201
• Est. completion date: July 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. All radical H&N patients receiving 30-35 fractions of Radiotherapy

2. Written informed consent obtained prior to any study-specific procedures

3. =18 years of age

Exclusion Criteria:

1) 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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Device:
• Conventional 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.
• 5 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.
• 3 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

Country	Name	City	State
Ireland	St. Luke's Radiation Oncology Network	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Irish Research Radiation Oncology Group

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	The mean and standard deviation of the GHQ-12 at first week and final week of treatment will be reported. Scoring will be in line with the published guidelines and will use the GHQ-12 summary score. The scales are from 1(Much less than usual) to 4(More so than usual) with 1 being the worst outcome and from 1(Much less able) to 4 (More so than usual) with 1 being the worst outcome. The proportion of patients who report 'More so than usual' for each domain or measure will be reported. Changes in scores over time for each patient will be calculated by subtracting the results at first week of treatment from the last week of treatment results. The mean and SD of the changes will be reported. A Wilcoxon signed rank test will be used to compare differences from baseline. The number of patients who had a clinically meaningful change in distress levels as identified by the method recommended by the EORTC QoL Group at the time of analysis will also be reported.	21 months