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Participants will receive a protracted course (30 days) of dexamethasone after surgery.

Participants will receive an abbreviated (14 days) course of dexamethasone after surgery.

Participants will receive a protracted (30 days) course of dexamethasone after surgery.

Participants will receive a protracted (14 days) course of dexamethasone after surgery.

Katherine B Peters, MD, PhD

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.

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.

Effects of Steroid Tapering on Functional Capacity and Neurocognition

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

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.

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.

Isokinetic muscle strength for bilateral grip and bilateral quadriceps.

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-mass index, weight, height, and circumference of the abdomen, hips, and quadriceps.

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).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effects of Steroid Tapering on Functional Capacity and Neurocognition	NCT01169415	Glioblastoma Mu...	Dexamethasone a... Dexamethasone	18 Years - 70 Years	Duke University
Effects of Steroid Tapering on Functional Capacity and Neurocognition	NCT01169415	Glioblastoma Mu...	Dexamethasone a... Dexamethasone	18 Years - 70 Years	Duke University

Spots Global Cancer Trial Database for protracted

Every month we try and update this database with for protracted cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for protracted

Every month we try and update this database with for protracted cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for protracted cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.