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
  Purpose

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 Intervention Phase
Brain Metastases
Small Cell Lung Cancer
Radiation: Whole brain radiotherapy with volumetric arc therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 29
Study Start Date: January 2013
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Whole brain radiotherapy with volumetric arc therapy
    Whole brain radiotherapy with volumetric arc therapy is used.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421316

Locations
Belgium
Ghent University Hospital, Belgium
Ghent, Belgium
Sponsors and Collaborators
University Hospital, Ghent
  More Information

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01421316     History of Changes
Other Study ID Numbers: 2011/504
Study First Received: August 17, 2011
Last Updated: July 30, 2013
Health Authority: Belgium: Ethics Committee

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
Lung Neoplasms
Small Cell Lung Carcinoma
Neoplastic Processes
Neoplasms
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on September 16, 2014