Comparing Immobilisation Shells in Cranial Radiotherapy

NCT ID: NCT02599142

Last Updated: 2020-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-10-22

Brief Summary

Patients having radiotherapy to their head and neck wear an immobilisation shell to prevent patient movement and improve treatment accuracy. These shells tend to cover the face and have the potential to cause anxiety and distress in patients, particularly if they suffer with claustrophobia or a similar fear. The study will use an 'open-face' shell that does not cover the face and compare this with the investigators' current 'closed-face' shell. The investigators will obtain treatment verification x-ray images to assess the daily set-up errors and compare these between the two shell type, and ask both patients and radiographers of their experiences from using the shells.

Hypothesis: Open-face immobilisation shells offer equivalent accuracy and efficiency of radiotherapy delivery and are better accepted by patients and radiographers as compared to closed-face immobilisation shells for cranial radiotherapy.

Detailed Description

Patients will be randomised into one of two groups, with group A acting as the control group using the investigators' standard 3--point closed--face shell, and group B using the 3--point open--face shell (experimental group). Each procedure is discussed with the patient before commencement. Patients will be positioned into the optimal treatment position and the shell will be fabricated as per manufacturer instructions by pre-treatment radiographers. This is followed by the patient having a planning CT scan of their head while wearing their shell to allows radiographers and doctors to localise and plan the treatment. At the end of this appointment, the patient will be asked to complete the first of three questionnaires regarding their experience of wearing the shell. Radiographers will be asked to complete a questionnaire of their experience of using the shell, and complete timing data for the procedures.

On the first day of treatment, radiographers will discuss the treatment process and side effects of treatment with the patient, and treatment will be delivered under current department protocols using linear accelerators (linacs). During the course of the treatment, radiographers will obtain 5 sets of verification images for the study, and these will be assessed for set-up errors as per current department policy. Where possible, treatment fields will be used to verify patient position to keep radiation doses from verification imaging as low as reasonably practicable (ALARP). Patients will be asked to complete two more questionnaires on their experience, one on their first day and one on their last day of treatment. Radiographers will also complete questionnaires on these days. Timing data will be obtained for all treatment fractions.

The patient's perspective of the planning and treatment processes will be almost identical to that of patients having cranial radiotherapy that are not in the trial. The only differences that will be observed will be the use of an open-face shell (for patients in group B), completion of three questionnaires, and additional verification imaging.

Conditions

Brain Metastases; Bone Metastases; Brain Tumor, Primary; Brain Tumor Adult; Brain Tumor - Metastatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A: Closed-face shells

Cranial radiotherapy using the control closed-face immobilisation shell.

Group Type: ACTIVE_COMPARATOR

Group A: Closed-face shell

Intervention Type: DEVICE

As for arm description

Group B: open-face shell

Cranial radiotherapy using the experimental open-face immobilisation shell

Group Type: EXPERIMENTAL

Group B: Open-face shell

Intervention Type: DEVICE

As for arm description

Interventions

Group A: Closed-face shell

As for arm description

Intervention Type: DEVICE

Group B: Open-face shell

As for arm description

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• patients prescribed cranial radiotherapy using virtually simulated parallel opposed fields with:
• 5 or more fractions of virtually simulated cranial radiotherapy
• treatment for Primary Central Nervous System Lymphoma (PCNSL), prophylactic cranial irradiation (PCI), or primary or secondary cerebral or bony lesions

Exclusion Criteria

• patients unable to give informed consent
• patients requiring conformal or inverse-planned radiotherapy
• patients requiring stereotactic radiotherapy
• patients who have previously had cranial or head and neck radiotherapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liam Welsh, PhD, FRCR

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

Royal Marsden Hospital NHS Foundation Trust

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

CCR4362

Identifier Type: -

Identifier Source: org_study_id