Investigating the Efficacy of Hair Sparing Radiotherapy Treatment to the Whole Brain. (SPARE)

February 20, 2019 updated by: Lynsey RICE, HCA International Limited

Investigating the Efficacy of Scalp Sparing Radiotherapy Treatment to the Whole Brain: Examining the Effect of Hair Loss and Re-growth

To investigate the use of a scalp sparing technique of radiotherapy treatment designed to treat the whole brain. Current treatment methods to treat the whole brain with radiotherapy result in complete alopecia as a side effect. Hair loss is usually patchy and uneven and re-growth similar and slow.

It is hoped that reducing the radiation dose to the hair bearing follicle on the scalp will reduce hair loss and increase the speed and evenness of re-growth.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Rationale for conducting the SPARE study:

The purpose of this study is to evaluate the effect of delivering WBRT via the VMAT method on hair loss and subsequent re-growth. Hair loss has been found to have a negative impact on QoL and can be particularly stressful for patients with a very short life expectancy, this is already well documented. Trying to minimise this treatment side effect, as previously stated in the literature, is a worthwhile investigation. This study is not looking at any prescribed dose changes to the established, evidence based and well documented prescriptions for WBRT. SPARE is an observational study of hair loss and re-growth during and after a patient's prescribed clinical treatment.

Aims and Objectives;

1) To observe hair loss and re-growth in patients undergoing Whole Brain Radiotherapy using the Volumetric Modulated Arc Therapy method of delivery.

As complete alopecia is expected in 100% of patients receiving conventionally delivered WBRT it will be considered a positive result if complete hair loss does not happen when using VMAT in this group of patients.

Assessment of hair loss and re-growth.

The assessment of hair loss and subsequent re-growth will be conducted using both objective and subjective assessments:

  1. Objective assessment: Photographic
  2. Subjective assessment: Patient interviews \ completion of a hair record sheet.

Photographic assessment:

Initial baseline photographs will be taken before any radiotherapy treatment is delivered on day one of the treatment schedule. Four photographs in total of the head, two laterals (left and right sides), the top (superior) and back (posterior). Subsequent serial photographs will be taken at two weeks, one, two, three, and four months after radiotherapy treatment.

Subjective assessment:

Patients will be asked to give their own opinion on their hair loss \ gain and this will be recorded on the hair record forms and completed by a member of the study team. This will be conducted at the same time intervals as the scalp photographs being taken.

Scalp photos will also be assessed by 2 independent members of the research team and scored using the same scales as the participant. Subsequent follow-up scalp pictures will be assessed against baseline (day 1) photos or complete alopecia images to assess re-growth.

Planning and Dosimetry:

Treatment plans will be generated using a 2 arc VMAT technique generated on Varian's Eclipse treatment planning system using 10 MV photons delivered on a Varian Clinac equipped with a Millennium Multileaf Collimator. Plans will be optimized selecting a maximum dose rate of 600 MU/min.

Study Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W1G 8PP
        • The Harley Street Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a positive cancer diagnosis requiring whole brain radiotherapy with a life expectancy greater than 4 months.

Description

Inclusion Criteria:

  • Adults over 18
  • Positive cancer diagnosis
  • Either proven brain metastasis or prophylaxis for primary lung cancer
  • Have no epilating chemotherapy planned
  • Basic understanding of English

Exclusion Criteria:

  • Previous whole brain radiotherapy
  • Pregnant females
  • Unable to give informed consent
  • Urgent cases that need same or next day treatment when referred

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
VMAT WBRT
Patients requiring whole brain radiotherapy as part of their cancer managment.
Radiation: VMAT (Volumetric Modulated Arc Therapy)
Delivering a prescribed radiation dose to the whole brain using VMAT to reduce dose to hair follicles on scalp.
Other Names:
  • Radiation Therapy
  • Radiation Oncology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess hair loss and hair regrowth in patients undergoing WBRT using VMAT via photographic assessment by independent professionals at intervals up to 16 weeks post end of treatment.
Time Frame: 4 months post radiotherapy treatment
4 months post radiotherapy treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess patient perceptions of hair loss and hair regrowth in patients undergoing WBRT using VMAT via self assessment at intervals up to 16 weeks post end of treatment.
Time Frame: 4 months post radiotherapy treatment end
4 months post radiotherapy treatment end

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HCA International Limited

Investigators

  • Study Chair: David Landau, DR, Clinical Oncologist with practising privilages at The Harley Street Clinic, HCA International Limited hospitals.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

February 20, 2019

Study Completion (Actual)

February 20, 2019

Study Registration Dates

First Submitted

August 8, 2014

First Submitted That Met QC Criteria

August 8, 2014

First Posted (Estimate)

August 11, 2014

Study Record Updates

Last Update Posted (Actual)

February 22, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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