Clinical trial NCT01169415: Effects of Steroid Tapering on Functional Capacity and Neurocognition
Official title: Effects of Dexamethasone Tapering Schedules on Functional Capacity and Neurocognition in Patients With Newly Diagnosed Glioblastoma Multiforme
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Glioblastoma Multiforme
Keywords: Randomized
Dexamethasone
Abbreviated
Protracted
Post-operatively
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2010-07-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Functional Capacity (6-minute walk test)
timeFrame: 10 weeks
Secondary outcomes:
measure: Neurocognitive Function
timeFrame: 10 weeks
measure: Skeletal Muscle Strength
timeFrame: 10 weeks
measure: Patient-Reported Outcomes (PROs)
timeFrame: 10 weeks
measure: Body composition
timeFrame: 10 weeks
measure: Biochemical metabolic measurements
timeFrame: 10 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Duke Health
name: Katherine B Peters, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: