The Use of Ginkgo Biloba For The Prevention Of Chemotherapy-Related Cognitive Dysfunction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 170
- 主要终点
- The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score.
研究概览
简要总结
RATIONALE: Chemotherapy may cause memory loss, attention loss, and other problems that make it difficult for patients to think clearly. EGb761 may help maintain mental clarity in patients undergoing chemotherapy.
PURPOSE: Randomized clinical trial to study the effectiveness of EGb761 in preventing loss of mental clarity in women who are receiving chemotherapy for newly diagnosed breast cancer.
详细描述
OBJECTIVES:
- Determine the effectiveness of EGb761 in the prevention of chemotherapy-related cognitive dysfunction in women with breast cancer.
- Determine the safety and tolerability of this drug when administered during adjuvant chemotherapy in these patients.
- Assess the onset and trajectory of cognitive loss that may occur during chemotherapy in these patients.
- Assess the quality of life and cognitive role functioning of patients treated with this drug.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to type of chemotherapy (doxorubicin/cyclophosphamide vs doxorubicin/cyclophosphamide with taxane vs other anthracycline-based chemotherapy vs other non-anthracycline-based chemotherapy), age (18 to 49 vs 50 and over), menopausal status at start of therapy (premenopausal vs postmenopausal vs unknown for surgical reasons), and lymph node involvement (0-3 vs 4 or more). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral EGb761 twice daily.
- Arm II: Patients receive oral placebo twice daily. Patients in both arms receive treatment beginning no later than the start of the second course of chemotherapy and continuing until 1 month after the completion of chemotherapy.
Quality of life and cognitive function are assessed at baseline, monthly during chemotherapy, and then at 1, 6, 12, 18, and 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 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
Ginkgo Biloba
120 mg per day (60 mg BID)
干预措施: Ginkgo Biloba (Drug)
Placebo
1 tablet BID
干预措施: Placebo (Other)
结局指标
主要结局
The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score.
时间窗: Baseline, 12 months after starting Chemotherapy.
The primary analysis involved compiling each subscale score for the HSCS into area under the curve (AUC) scores for the data points from baseline to the 12 month data point. HSCS instrument contains questions regarding Memory (0-39), Language (0-30), Visual-motor (0-10), Spatial (0-8), Attention and Concentration (0-25), Self-Regulation and Planning (0-6) on a varying scales. Total is calculated by summing afore mentioned subscales, values of Total ranged from 0 to 125. Lower scores are better.
次要结局
- Median Scores for Trail Making Tests A and B (Lower Scores Are Better).(Baseline, 1, 6, 12, 18 and 24 months time points)
- Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B.(Baseline, 1, 6, 12, 18 and 24 months post chemotherapy.)
- Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED)(Baseline, 1st evaluation of post chemotherapy.)
- Associations Between Self-reported Cognition and the HSCS.(Baseline, 1, 6, 12, 18 and 24 months time points)
- Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B.(Baseline, 1, 6, 12, 18 and 24 months time points)