Hair-sparing Whole Brain Radiotherapy

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01421316

Enrollment

Registered

2011-08-22

Start date

2013-01-31

Completion date

2014-10-31

Last updated

2015-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Metastases, Small Cell Lung Cancer

Keywords

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).

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.

Interventions

RADIATIONWhole brain radiotherapy with volumetric arc therapy

Whole brain radiotherapy with volumetric arc therapy is used.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Hair quality before treatment and at 1 month following treatment.	at 1 month following treatment	Key measurements: trichogram are used.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026