Hair-sparing Whole Brain Radiotherapy

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. Read our disclaimer for details. Identifier: NCT01421316
Recruitment Status : Terminated (No reduction in hair loss 1 month after treatment)
First Posted : August 22, 2011
Last Update Posted : June 4, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Brain Metastases Small Cell Lung Cancer Radiation: Whole brain radiotherapy with volumetric arc therapy Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Hair Loss With Volumetric Arc Therapy in Patients Treated With Whole Brain Radiotherapy: a Phase II Trial
Study Start Date : January 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Intervention Details:
  • Radiation: Whole brain radiotherapy with volumetric arc therapy
    Whole brain radiotherapy with volumetric arc therapy is used.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Hair quality before treatment and at 1 month following treatment. [ Time Frame: at 1 month following treatment ]
    Key measurements: trichogram are used.

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

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

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 identifier (NCT number): NCT01421316

Ghent University Hospital, Belgium
Ghent, Belgium
Sponsors and Collaborators
University Hospital, Ghent

Responsible Party: University Hospital, Ghent Identifier: NCT01421316     History of Changes
Other Study ID Numbers: 2011/504
First Posted: August 22, 2011    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015

Keywords provided by University Hospital, Ghent:
Patients treated with whole brain radiotherapy in the setting of brain metastases
Patients treated with whole brain radiotherapy in the prophylactic treatment for small cell lung cancer (extended disease).

Additional relevant MeSH terms:
Neoplasm Metastasis
Small Cell Lung Carcinoma
Neoplastic Processes
Pathologic Processes
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases