Effects of Steroid Tapering on Functional Capacity and Neurocognition

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Glioblastoma Multiforme

Intervention / Treatment
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* Drug: Dexamethasone acetate
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protracted (30 days), Dexamethasone<br>Participants will receive a protracted course (30 days) of dexamethasone after surgery. | Drug: Dexamethasone acetate<br>* Participants will receive a protracted (30 days) course of dexamethasone after surgery.<br>* Other names: Decadron;|
| Experimental: Abbreviated (14 days), dexamethasone<br>Participants will receive an abbreviated (14 days) course of dexamethasone after surgery. | Drug: Dexamethasone<br>* Participants will receive a protracted (14 days) course of dexamethasone after surgery.<br>* Other names: Decadron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Capacity (6-minute walk test) | 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. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive Function | 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. | 10 weeks | 
| Skeletal Muscle Strength | Isokinetic muscle strength for bilateral grip and bilateral quadriceps. | 10 weeks | 
| Patient-Reported Outcomes (PROs) | 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). | 10 weeks | 
| Body composition | Body-mass index, weight, height, and circumference of the abdomen, hips, and quadriceps. | 10 weeks | 
| Biochemical metabolic measurements | 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). | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized, Dexamethasone, Abbreviated, Protracted, Post-operatively