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Effects of Steroid Tapering on Functional Capacity and Neurocognition

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glioblastoma Multiforme

Intervention: Dexamethasone acetate (Drug); Dexamethasone (Drug)

Phase: N/A

Status: Withdrawn

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
Katherine B Peters, MD, PhD, Principal Investigator, Affiliation: Duke University Health System

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 Details

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

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

Primary outcome: Functional Capacity (6-minute walk test)

Secondary outcome:

Neurocognitive Function

Skeletal Muscle Strength

Patient-Reported Outcomes (PROs)

Body composition

Biochemical metabolic measurements

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.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: June 2010
Last updated: May 15, 2014

Page last updated: August 23, 2015

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