Clinical trial · Interventional
Effects of Steroid Tapering on Functional Capacity and Neurocognition
Effects of Dexamethasone Tapering Schedules on Functional Capacity and Neurocognition in Patients With Newly Diagnosed Glioblastoma Multiforme
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding not obtained
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Dexamethasone acetate | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Protracted (30 days), Dexamethasone
- description
- Participants will receive a protracted course (30 days) of dexamethasone after surgery.
- interventionNames
- Drug: Dexamethasone acetate
- type
- EXPERIMENTAL
- label
- Abbreviated (14 days), dexamethasone
- description
- Participants will receive an abbreviated (14 days) course of dexamethasone after surgery.
- interventionNames
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Functional Capacity (6-minute walk test)
- timeFrame
- 10 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available