Hair-sparing Whole Brain Radiotherapy
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|ClinicalTrials.gov 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
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- Radiation: Whole brain radiotherapy with volumetric arc therapy
Whole brain radiotherapy with volumetric arc therapy is used.
- 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.
- Hair quality before treatment and at 1 month following treatment. [ Time Frame: at 1 month following treatment ]Key measurements: trichogram are used.
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 ClinicalTrials.gov identifier (NCT number): NCT01421316
|Ghent University Hospital, Belgium|