Phase II Randomized Evaluation of 5-Lipoxygenase Inhibition by Herbal Complementary and Alternative Medicine Approach Compared to Control as an Adjuvant Therapy in Newly Diagnosed and Recurrent High-grade Gliomas
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change From Pooled Baseline in Peritumoral Brain Edema
研究概览
简要总结
RATIONALE: Giving the herb Boswellia serrata after surgery and radiation therapy may slow the growth of any remaining tumor cells. It is not yet known whether giving Boswellia serrata together with standard treatment is more effective than standard treatment alone in treating high-grade gliomas.
PURPOSE: This randomized phase II trial is the study of a combination of complementary and alternative medicine (CAM) herbal supplement intervention as an adjuvant to standard treatment of patients with newly diagnosed and recurrent high-grade gliomas (HGG). The central hypothesis of this application is that a herbal preparation that inhibits 5-LO activity, will produce measurable biologically meaningful decrease in 5-LO eicosanoid production and brain edema that will be associated with improved survival and quality of life in patients with HGG.
详细描述
OBJECTIVES:
Primary
- To determine whether a herbal approach to decreasing 5-LO eicosanoid production reduces peritumoral brain edema in patients with HGG.
Secondary
- To determine if this adjuvant approach improves the quality of life and progression free and overall survival of patients with HGG.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I (intervention)
Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.
干预措施: Boswellia serrata extract (Drug)
Arm I (intervention)
Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.
干预措施: cyanocobalamin (Dietary Supplement)
Arm II (control)
Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
干预措施: cyanocobalamin (Dietary Supplement)
结局指标
主要结局
Change From Pooled Baseline in Peritumoral Brain Edema
时间窗: at 2 months
The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation. For each patient change = edema at follow up - baseline edema
Change From Baseline in Peritumoral Brain Edema
时间窗: at 6 months
The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation. For each patient change = edema at follow up - baseline edema.
次要结局
- Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 1 Year(1 year)
- Overall Survival: Percentage of Patients That Were Alive at 1 Year(1 year.)
- Quality of Life at 6 Months(At 2, 4, 6, 12, and 24 months)
- Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 6 Months(6 months)
研究者
Ali Altunkaya
Principal Investigator
Case Comprehensive Cancer Center