Hair-sparing Whole Brain Radiotherapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Brain Metastases, Small Cell Lung Cancer

Intervention / Treatment
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* Radiation: Whole brain radiotherapy with volumetric arc therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Whole brain radiotherapy with volumetric arc therapy|Whole brain radiotherapy with volumetric arc therapy is used.|

What is the study measuring?
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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. | 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. | Key measurements: trichogram are used. | at 1 month following treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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).