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

NCT ID: NCT02213536

Last Updated: 2019-02-22

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2019-02-20

Brief Summary

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.

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.

Conditions

Metastatic Brain Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

VMAT WBRT

Patients requiring whole brain radiotherapy as part of their cancer managment.

VMAT (Volumetric Modulated Arc Therapy)

Intervention Type: RADIATION

Delivering a prescribed radiation dose to the whole brain using VMAT to reduce dose to hair follicles on scalp.

Interventions

VMAT (Volumetric Modulated Arc Therapy)

Delivering a prescribed radiation dose to the whole brain using VMAT to reduce dose to hair follicles on scalp.

Intervention Type: RADIATION

Other Intervention Names

Radiation Therapy; Radiation Oncology

Eligibility 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

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

Sponsors

HCA International Limited

OTHER

Sponsor Role: lead

Responsible Party

Lynsey RICE

Research and Development radiographer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Landau, DR

Role: STUDY_CHAIR

Clinical Oncologist with practising privilages at The Harley Street Clinic, HCA International Limited hospitals.

Locations

The Harley Street Clinic

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

HCA

Identifier Type: -

Identifier Source: org_study_id