Hair-sparing Whole Brain Radiotherapy

Phase 2

Terminated

• Conditions: Brain Metastases; Small Cell Lung Cancer

• Registration Number: NCT01421316
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-17
• Study First Submitted QC: 2011-08-19
• Study First Posted: 2011-08-22
• Study Start: 2013-01
• Primary Completion: 2013-09
• Study Completion: 2014-10
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Hair quality before treatment and at 1 month following treatment.	at 1 month following treatment	Key measurements: trichogram are used.

Trial Locations

Locations (1)

Ghent University Hospital, Belgium; 🇧🇪 Ghent, Belgium