Effects of Steroid Tapering on Functional Capacity and Neurocognition

Duke University

Status: Withdrawn

Conditions: Glioblastoma Multiforme

Treatments: Drug: Dexamethasone; Drug: Dexamethasone acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT01169415

Pro00024406

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Protracted (30 days), Dexamethasone

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone acetate

Abbreviated (14 days), dexamethasone

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone