Effects of Steroid Tapering on Functional Capacity and Neurocognition

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01169415
• Other study ID #: Pro00024406
• Status: Withdrawn
• Phase: N/A
• First received: June 25, 2010
• Last updated: May 15, 2014
• Start date: June 2010
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Drug:
• Dexamethasone acetate
Participants will receive a protracted (30 days) course of dexamethasone after surgery.
• Dexamethasone
Participants will receive a protracted (14 days) course of dexamethasone after surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Neurocognitive Function	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.	10 weeks	No
Secondary	Skeletal Muscle Strength	Isokinetic muscle strength for bilateral grip and bilateral quadriceps.	10 weeks	No
Secondary	Patient-Reported Outcomes (PROs)	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).	10 weeks	No
Secondary	Body composition	Body-mass index, weight, height, and circumference of the abdomen, hips, and quadriceps.	10 weeks	No
Secondary	Biochemical metabolic measurements	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).	10 weeks	No