Effects of Steroid Tapering on Functional Capacity and Neurocognition
Status:
Withdrawn
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
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 (i.e. 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.