Effects of Dexamethasone Tapering Schedules on Functional Capacity and Neurocognition in Patients With Newly Diagnosed Glioblastoma Multiforme
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Functional Capacity (6-minute walk test)
研究概览
简要总结
Purpose and Objective:
- To compare the effects of either an abbreviated or protracted taper of dexamethasone on functional capacity in newly diagnosed glioblastoma multiforme (GBM) patients.
- To compare neurocognitive function in newly diagnosed GBM patients receiving either an abbreviated or protracted taper of dexamethasone.
- To compare skeletal muscle strength in newly diagnosed GBM patients receiving either an abbreviated or protracted taper of dexamethasone.
- 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.
- 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.
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent prior to beginning specific protocol procedures,
- •histologically proven GBM,
- •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),
- •>18 years and <70 years of age,
- •Karnofsky performance index >70%,
- •no documented cardiac, neurodegenerative, neuromuscular, or pulmonary disease,
- •no contraindications to a 6-minute walk test,
- •no contraindications to neurocognitive testing,
- •primary treating physician approval, and
- •no complications operatively or postoperatively that requires modification of dexamethasone dosing.
- •receiving dexamethasone as standard of care.
排除标准
- 未提供
研究组 & 干预措施
Protracted (30 days), Dexamethasone
Participants will receive a protracted course (30 days) of dexamethasone after surgery.
干预措施: Dexamethasone acetate (Drug)
Abbreviated (14 days), dexamethasone
Participants will receive an abbreviated (14 days) course of dexamethasone after surgery.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Functional Capacity (6-minute walk test)
时间窗: 10 weeks
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.
次要结局
- Neurocognitive Function(10 weeks)
- Skeletal Muscle Strength(10 weeks)
- Patient-Reported Outcomes (PROs)(10 weeks)
- Body composition(10 weeks)
- Biochemical metabolic measurements(10 weeks)