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


N/A
18 Years
70 Years
Not Enrolling
Both
Glioblastoma Multiforme

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Trial Information

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


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.


Inclusion Criteria:



1. written informed consent prior to beginning specific protocol procedures,

2. histologically proven GBM,

3. 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),

4. >18 years and <70 years of age,

5. Karnofsky performance index >70%,

6. no documented cardiac, neurodegenerative, neuromuscular, or pulmonary disease,

7. no contraindications to a 6-minute walk test,

8. no contraindications to neurocognitive testing,

9. primary treating physician approval, and

10. no complications operatively or postoperatively that requires modification of
dexamethasone dosing.

11. receiving dexamethasone as standard of care.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Functional Capacity (6-minute walk test)

Outcome Description:

The exercise test is designed to determine how far you can walk in six minutes. This test will take place at the PRT-BTC at Duke University Medical Center and/or Duke University Medical Center inpatient unit on 4100 or 4300 with appropriate medical supervision.

Outcome Time Frame:

10 weeks

Safety Issue:

No

Principal Investigator

Katherine B Peters, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Health System

Authority:

United States: Institutional Review Board

Study ID:

Pro00024406

NCT ID:

NCT01169415

Start Date:

August 2013

Completion Date:

August 2016

Related Keywords:

  • Glioblastoma Multiforme
  • Randomized
  • Dexamethasone
  • Abbreviated
  • Protracted
  • Post-operatively
  • Glioblastoma

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