Effects of Steroid Tapering on Functional Capacity and Neurocognition

NCT ID: NCT01169415

Last Updated: 2014-05-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2014-05-31

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.

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.

Conditions

Glioblastoma Multiforme

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Protracted (30 days), Dexamethasone

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

Group Type: EXPERIMENTAL

Dexamethasone acetate

Intervention Type: DRUG

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

Abbreviated (14 days), dexamethasone

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

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

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

Interventions

Dexamethasone acetate

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

Intervention Type: DRUG

Dexamethasone

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

Intervention Type: DRUG

Other Intervention Names

Decadron; Decadron

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine B Peters, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Other Identifiers

Pro00024406

Identifier Type: -

Identifier Source: org_study_id