Hair-sparing Whole Brain Radiotherapy

June 3, 2015 updated by: University Hospital, Ghent

Reducing Hair Loss With Volumetric Arc Therapy in Patients Treated With Whole Brain Radiotherapy: a Phase II Trial

Up to 10% of patients with cancer will develop symptomatic brain metastases. Given this limited survival it is important to consider quality of life (QOL) when treating these patients. Whole brain radiotherapy (WBRT) can increase survival to 6 month. However, WBRT itself has been shown to reduce QOL by increasing drowsiness, leg weakness and hair loss in patients with brain metastases. Both fatigue and hair loss were reported to have the largest decline in QOL scores when WBRT is used in the prophylactic setting in small cell lung cancer. Recent technological improvements in patient positioning and treatment planning will allow us to treat the whole brain with reduced margins, allowing better sparing of the scalp. In view of the large impact of hair loss on quality of life, the investigators hypothesize to see an improved quality of life with scalp sparing techniques.

Study hypothesis: Volumetric arc therapy results in a reduced hair loss and a subsequent clinically important improvement in QOL.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

29

Phase

  • Phase 2

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

  • Belgium
      • Ghent, Belgium
        • Ghent University Hospital, Belgium

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Brain metastases
  • Age ≥ 18 years.
  • Signed informed consent
  • Recursive Partitioning Analysis (RPA) class III patients
  • Recursive Partitioning Analysis (RPA) class I-II patients and >3 brain metastases
  • Patients with small cell lung cancer extended disease eligible for prophylactic Whole-Brain Radiotherapy (WBRT).

Exclusion Criteria:

  • Previous whole brain radiotherapy

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The European Organization for Research and Treatment of Cancer (EORTC)quality of life questionnaire (C15-PAL and BN20) measured at 1 month following treatment.
Time Frame: At 1 month.
Quality of life questionnaires are used.
At 1 month.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hair quality before treatment and at 1 month following treatment.
Time Frame: at 1 month following treatment
Key measurements: trichogram are used.
at 1 month following treatment

Collaborators and Investigators

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

Sponsor

University Hospital, Ghent

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

January 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

August 17, 2011

First Submitted That Met QC Criteria

August 19, 2011

First Posted (Estimate)

August 22, 2011

Study Record Updates

Last Update Posted (Estimate)

June 4, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/504

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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