Comparing Immobilisation Shells in Cranial Radiotherapy

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Brief Title

Comparing Immobilisation Shells in Cranial Radiotherapy

Official Title

A Randomised Controlled Trial Comparing the Accuracy and Acceptability of Closed-face and Open-face Thermoplastic Immobilisation Shells in Cranial Radiotherapy

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.
    


Study Type

Interventional


Primary Outcome

Assessment of treatment verification imaging to determine inter-fraction reproducability of immobilisation shells

Secondary Outcome

 Timing data

Condition

Brain Metastases

Intervention

Group A: Closed-face shell

Study Arms / Comparison Groups

 Group A: Closed-face shells
Description:  Cranial radiotherapy using the control closed-face immobilisation shell.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

41

Start Date

November 2015

Completion Date

October 22, 2018

Primary Completion Date

October 22, 2018

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Liam Welsh, PhD, FRCR, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT02599142

Organization ID

CCR4362


Responsible Party

Sponsor

Study Sponsor

Royal Marsden NHS Foundation Trust

Collaborators

 National Institute for Health Research, United Kingdom

Study Sponsor

Liam Welsh, PhD, FRCR, Principal Investigator, Royal Marsden NHS Foundation Trust


Verification Date

May 2020