Effects of Steroid Tapering on Functional Capacity and Neurocognition

This study has been withdrawn prior to enrollment.

(Funding not obtained)

Sponsor:

ClinicalTrials.gov Identifier:

NCT01169415

First Posted: July 26, 2010

Last Update Posted: May 19, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Duke University

Purpose

Purpose and Objective:

To compare the effects of either an abbreviated or protracted taper of dexamethasone on functional capacity in newly diagnosed glioblastoma multiforme (GBM) patients.
To compare neurocognitive function in newly diagnosed GBM patients receiving either an abbreviated or protracted taper of dexamethasone.
To compare skeletal muscle strength in newly diagnosed GBM patients receiving either an abbreviated or protracted taper of dexamethasone.
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.
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.
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.

Condition	Intervention
Glioblastoma Multiforme	Drug: Dexamethasone acetate Drug: Dexamethasone


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Effects of Dexamethasone Tapering Schedules on Functional Capacity and Neurocognition in Patients With Newly Diagnosed Glioblastoma Multiforme

Resource links provided by NLM:

Drug Information available for: Dexamethasone Dexamethasone sodium phosphate Dexamethasone acetate

Genetic and Rare Diseases Information Center resources: Glioblastoma Glioma Neuroepithelioma

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

Functional Capacity (6-minute walk test) [ Time Frame: 10 weeks ]
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.

Secondary Outcome Measures:

Neurocognitive Function [ Time Frame: 10 weeks ]
A computerized neurocognitive test battery called CNS Vital Signs® including verbal memory test, visual memory test, finger tapping test, symbol digit coding, Stroop test, shifting attention test, continuous performance test.
Skeletal Muscle Strength [ Time Frame: 10 weeks ]
Isokinetic muscle strength for bilateral grip and bilateral quadriceps.
Patient-Reported Outcomes (PROs) [ Time Frame: 10 weeks ]
Assessed by standardized and validated questionnaires including: Depression (Beck Depression Inventory); Quality of Life (Functional Assessment of Cancer Therapy-Brain); Fatigue (Functional Assessment of Cancer Therapy-Fatigue); Cognition (Functional Assessment of Cancer Therapy-Cognition), Symptomalogy Index (Phone Questionnarie/Survery), Computerized Battery from CNS Vital Signs (Medical Outcomes Survey, Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Zung Self-Rating Depression Scale).
Body composition [ Time Frame: 10 weeks ]
Body-mass index, weight, height, and circumference of the abdomen, hips, and quadriceps.
Biochemical metabolic measurements [ Time Frame: 10 weeks ]
Hematocrit (%), albumin (g/mL), fasting blood glucose (mg/dL), fasting insulin (micro IU/mL), insulin like growth facto binding protein 1 (IGFBP-1) (ng/mL), cystatin C (mg/dL), and retinol binding protein 4 (RBP-4).


Enrollment:	0
Study Start Date:	June 2010
Study Completion Date:	May 2014
Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Protracted (30 days), Dexamethasone Participants will receive a protracted course (30 days) of dexamethasone after surgery.	Drug: Dexamethasone acetate Participants will receive a protracted (30 days) course of dexamethasone after surgery. Other Name: Decadron
Experimental: Abbreviated (14 days), dexamethasone Participants will receive an abbreviated (14 days) course of dexamethasone after surgery.	Drug: Dexamethasone Participants will receive a protracted (14 days) course of dexamethasone after surgery. Other Name: Decadron

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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

written informed consent prior to beginning specific protocol procedures,
histologically proven GBM,
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),
>18 years and <70 years of age,
Karnofsky performance index >70%,
no documented cardiac, neurodegenerative, neuromuscular, or pulmonary disease,
no contraindications to a 6-minute walk test,
no contraindications to neurocognitive testing,
primary treating physician approval, and
no complications operatively or postoperatively that requires modification of dexamethasone dosing.
receiving dexamethasone as standard of care.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01169415

Sponsors and Collaborators

Duke University

Investigators


Principal Investigator:	Katherine B Peters, MD, PhD	Duke University Health System

More Information


Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT01169415 History of Changes
Other Study ID Numbers:	Pro00024406
First Submitted:	June 25, 2010
First Posted:	July 26, 2010
Last Update Posted:	May 19, 2014
Last Verified:	May 2014

Keywords provided by Duke University:


Randomized Dexamethasone Abbreviated Protracted Post-operatively

Additional relevant MeSH terms:


Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Dexamethasone acetate Dexamethasone BB 1101 Anti-Inflammatory Agents	Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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