Effects of Steroid Tapering on Functional Capacity and Neurocognition

NCT01169415 | Withdrawn DMC

• 1 other identifier: Pro00024406
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Purpose and Objective:

1. 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. 2.To compare neurocognitive function in newly diagnosed GBM patients receiving either an abbreviated or protracted taper of dexamethasone.
3. 3.To compare skeletal muscle strength in newly diagnosed GBM patients receiving either an abbreviated or protracted taper of dexamethasone.
4. 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. 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. 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.

Conditions

Glioblastoma Multiforme

Keywords

Randomized; Dexamethasone; Abbreviated; Protracted; Post-operatively

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Neurocognitive Function

  10 weeks

• Skeletal Muscle Strength

  10 weeks

• Patient-Reported Outcomes (PROs)

  10 weeks

• Body composition

  10 weeks

• Biochemical metabolic measurements

  10 weeks

Study Arms (2)

Protracted (30 days), Dexamethasone

EXPERIMENTAL

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

Drug: Dexamethasone acetate

Abbreviated (14 days), dexamethasone

EXPERIMENTAL

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

Drug: Dexamethasone

Interventions

Dexamethasone acetate DRUG

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

Also known as: Decadron

Protracted (30 days), Dexamethasone

Dexamethasone DRUG

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

Also known as: Decadron

Abbreviated (14 days), dexamethasone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Glioblastoma

Interventions

dexamethasone acetate; Calcium Dobesilate; Dexamethasone

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Katherine B Peters, MD, PhD

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: July 26, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 19, 2014

Record last verified: 2014-05