We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified February 2016 by Lynsey RICE, HCA International Limited
Sponsor:
ClinicalTrials.gov Identifier:
NCT02213536
First Posted: August 11, 2014
Last Update Posted: February 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Lynsey RICE, HCA International Limited
  Purpose

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.


Condition Intervention
Metastatic Brain Cancer Radiation: VMAT (Volumetric Modulated Arc Therapy)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Investigating the Efficacy of Scalp Sparing Radiotherapy Treatment to the Whole Brain: Examining the Effect of Hair Loss and Re-growth

Further study details as provided by Lynsey RICE, HCA International Limited:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: August 2015
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213536


Contacts
Contact: Lynsey Rice 442070348338 lynsey.rice@hcahealthcare.co.uk

Locations
United Kingdom
The Harley Street Clinic Recruiting
London, United Kingdom, W1G 8PP
Contact: Lynsey Rice    442070348338    lynsey.rice@hcahealthcare.co.uk   
Contact: Christy Goldsmith    442070348594    christy.goldsmith@hcahealthcare.co.uk   
Principal Investigator: David Landau         
Sponsors and Collaborators
HCA International Limited
Investigators
Study Chair: David Landau, DR Clinical Oncologist with practising privilages at The Harley Street Clinic, HCA International Limited hospitals.
  More Information

Responsible Party: Lynsey RICE, Research and Development radiographer, HCA International Limited
ClinicalTrials.gov Identifier: NCT02213536     History of Changes
Other Study ID Numbers: HCA
First Submitted: August 8, 2014
First Posted: August 11, 2014
Last Update Posted: February 19, 2016
Last Verified: February 2016

Keywords provided by Lynsey RICE, HCA International Limited:
Metastatic brain cancer
Whole brain radiotherapy
Scalp sparing whole brain radiotherapy
Prophylactic whole brain radiotherapy

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases