Ignite Creation Date:
2024-05-05 @ 10:40 PM
Last Modification Date:
2024-10-26 @ 10:23 AM
Study NCT ID:
NCT01169415
Status:
WITHDRAWN
Last Update Posted:
2014-05-19
First Post:
2010-06-25
Brief Title:
Effects of Steroid Tapering on Functional Capacity and Neurocognition
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Effects of Dexamethasone Tapering Schedules on Functional Capacity and Neurocognition in Patients With Newly Diagnosed Glioblastoma Multiforme
Status:
WITHDRAWN
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding not obtained
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 compare neurocognitive function in newly diagnosed GBM patients receiving either an abbreviated or protracted taper of dexamethasone
3 To compare skeletal muscle strength in newly diagnosed GBM patients receiving either an abbreviated or protracted taper of dexamethasone
4 To examine the association between functional capacity and neurocognitive function and patient-reported measures ie quality of life fatigue etc in newly diagnosed GBM patient on either an abbreviated or protracted taper of dexamethasone
5 To examine the association between functional capacity and neurocognitive function and body composition measures body-mass index etc in newly diagnosed GBM patient on either an abbreviated or protracted taper of dexamethasone
6 To examine the association between functional capacity and neurocognitive function and biochemical metabolic measurements in newly diagnosed GBM patient on either an abbreviated or protracted taper of dexamethasone
All study endpoints will be assessed at three timepoints as follows 1 initial assessment after surgery in the hospital 2 second assessment at initial clinical visit at the Preston Robert Tisch Brain Tumor Center PRT-BTC at Duke approximately 1 week post-operatively and 3 third assessment at second clinical visit in the PRT-BTC at Duke approximately 10 weeks post-operatively and after completion of radiotherapy An additional fourth assessment will be obtained at 4 weeks post-operatively if the subject is undergoing radiotherapy here at Duke
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 compare neurocognitive function in newly diagnosed GBM patients receiving either an abbreviated or protracted taper of dexamethasone
3 To compare skeletal muscle strength in newly diagnosed GBM patients receiving either an abbreviated or protracted taper of dexamethasone
4 To examine the association between functional capacity and neurocognitive function and patient-reported measures ie quality of life fatigue etc in newly diagnosed GBM patient on either an abbreviated or protracted taper of dexamethasone
5 To examine the association between functional capacity and neurocognitive function and body composition measures body-mass index etc in newly diagnosed GBM patient on either an abbreviated or protracted taper of dexamethasone
6 To examine the association between functional capacity and neurocognitive function and biochemical metabolic measurements in newly diagnosed GBM patient on either an abbreviated or protracted taper of dexamethasone
All study endpoints will be assessed at three timepoints as follows 1 initial assessment after surgery in the hospital 2 second assessment at initial clinical visit at the Preston Robert Tisch Brain Tumor Center PRT-BTC at Duke approximately 1 week post-operatively and 3 third assessment at second clinical visit in the PRT-BTC at Duke approximately 10 weeks post-operatively and after completion of radiotherapy An additional fourth assessment will be obtained at 4 weeks post-operatively if the subject is undergoing radiotherapy here at Duke
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 dexamethasone post-operatively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None