Effects of Steroid Tapering on Functional Capacity and Neurocognition

• ClinicalTrials.gov Identifier: NCT01169415
• Recruitment Status: Withdrawn
• First Posted: July 26, 2010
• Last Update Posted: May 19, 2014
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Glioblastoma Multiforme	Drug: Dexamethasone acetate; Drug: Dexamethasone	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• 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
• Study Start Date: June 2010
• Actual Primary Completion Date: May 2014
• Actual Study Completion Date: May 2014

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.
2. Skeletal Muscle Strength [ Time Frame: 10 weeks ]
   Isokinetic muscle strength for bilateral grip and bilateral quadriceps.
3. 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).
4. Body composition [ Time Frame: 10 weeks ]
   Body-mass index, weight, height, and circumference of the abdomen, hips, and quadriceps.
5. 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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
• Other Study ID Numbers: Pro00024406
• 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; Dexamethasone acetate; 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