Effects of Steroid Tapering on Functional Capacity and Neurocognition

This study is not yet open for participant recruitment.
Verified October 2013 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01169415
First received: June 25, 2010
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Glioblastoma Multiforme
Drug: Dexamethasone acetate
Drug: Dexamethasone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Functional Capacity (6-minute walk test) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Isokinetic muscle strength for bilateral grip and bilateral quadriceps.

  • Patient-Reported Outcomes (PROs) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Body-mass index, weight, height, and circumference of the abdomen, hips, and quadriceps.

  • Biochemical metabolic measurements [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 100
Study Start Date: December 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2015 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169415

Contacts
Contact: Katherine B Peters, MD, PhD (919) 684-3914 katherine.peters@duke.edu
Contact: Maria W Freeman, RN, BSN (919) 684-3440 freem050@mc.duke.edu

Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Katherine B Peters, MD, PhD Duke University Health System
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01169415     History of Changes
Other Study ID Numbers: Pro00024406
Study First Received: June 25, 2010
Last Updated: October 25, 2013
Health Authority: United States: Institutional Review Board

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
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014