Status:
WITHDRAWN
Effects of Steroid Tapering on Functional Capacity and Neurocognition
Lead Sponsor:
Duke University
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Purpose and Objective: 1. To compare the effects of either an abbreviated or protracted taper of dexamethasone on functional capacity in newly diagnosed glioblastoma multiforme (GBM) patients. 2. To ...
Detailed Description
The proposed study is a randomized controlled trial. After obtaining written informed consent, all participants will be randomized to either an abbreviated (14 days) or protracted (30 days) course of ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- written informed consent prior to beginning specific protocol procedures,
- histologically proven GBM,
- status-post gross total resection or subtotal resection as indicated by \< 2 cm of residual enhancing disease (subjects with unresectable, multifocal, and /or bulky disease will be excluded),
- \>18 years and \<70 years of age,
- Karnofsky performance index \>70%,
- no documented cardiac, neurodegenerative, neuromuscular, or pulmonary disease,
- no contraindications to a 6-minute walk test,
- no contraindications to neurocognitive testing,
- primary treating physician approval, and
- no complications operatively or postoperatively that requires modification of dexamethasone dosing.
- receiving dexamethasone as standard of care.
Exclusion
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01169415
Start Date
June 1 2010
End Date
May 1 2014
Last Update
May 19 2014
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