Hair-sparing Whole Brain Radiotherapy

This study has been terminated.
(No reduction in hair loss 1 month after treatment)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01421316
First received: August 17, 2011
Last updated: July 30, 2013
Last verified: July 2013

August 17, 2011
July 30, 2013
January 2013
September 2013   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Quality of life questionnaires are used.
Same as current
Complete list of historical versions of study NCT01421316 on ClinicalTrials.gov Archive Site
Hair quality before treatment and at 1 month following treatment. [ Time Frame: at 1 month following treatment ] [ Designated as safety issue: No ]
Key measurements: trichogram are used.
Same as current
Not Provided
Not Provided
 
Hair-sparing Whole Brain Radiotherapy
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Brain Metastases
  • Small Cell Lung Cancer
Radiation: Whole brain radiotherapy with volumetric arc therapy
Whole brain radiotherapy with volumetric arc therapy is used.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
29
October 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01421316
2011/504
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Not Provided
University Hospital, Ghent
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP