Effects of Steroid Tapering on Functional Capacity and Neurocognition

Glioblastoma Multiforme Clinical Trial

Official title: Effects of Dexamethasone Tapering Schedules on Functional Capacity and Neurocognition in Patients With Newly Diagnosed Glioblastoma Multiforme

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

• NCT number: NCT01169415
• Study type: Interventional
• Source: Duke University
• Status: Withdrawn
• Phase: N/A
• Start date: June 2010
• Completion date: May 2014