The Effects of Ganglioside-Monosialic Acid in Post-chemotherapy Cognitive Impairment in Patients With Early Operable Breast Cancer: A Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- HVLT R-DR
研究概览
简要总结
The purpose of this study is to evaluate the prophylactic effects of Ganglioside-Monosialic Acid in post-chemotherapy cognitive impairment in patients with early operable breast cancer.
详细描述
This is a multicenter, prospective, randomized, single-blind, phase III clinical trial. The primary endpoint is the changes of cognitive function from baseline to 4 weeks after the completion of adjuvant chemotherapy in the experimental group and the control group, which were evaluated by HVLT-R scale. This study is designed to recruit up to 306 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have provided written and signed informed consent;
- •Histologically confirmed invasive ductal carcinoma;
- •Planned to received (neo)/adjuvant chemotherapy;
- •Eastern Cooperative Oncology Group (ECOG) score of 0 to 1;
- •Can cope with HVLT-RDR and ADAS-Cog evaluation;
- •No prior therapy could induce neurological damage,within 4 weeks
- •Normal blood routine, liver and kidney functions within 1 week before enrollment in this study;
- •Women of childbearing age have a negative serum or urinary pregnancy tests prior to enrollment in this study; Pre-menopause women are contracepted with medically acceptable methods during the study period.
- •Compliance with the study protocol.
排除标准
- •Eastern Cooperative Oncology Group (ECOG) score ≥ 2;
- •Hypersensitivity to experiment agents or components;
- •Women with pregnancy or breast feeding;
- •A clear past history of neurological or psychiatric disorders, including epilepsy or dementia;
- •Abnormal baseline impairment of cognitive impairment;
- •Poor compliance, unwillingness or inability to follow protocol to continue the study;
- •Any circumstances in which the investigator deemed the subject unsuitable for enrollment in this study.
研究组 & 干预措施
experimental group
standard (neo)adjuvant chemotherapy plus Ganglioside-Monosialic Acid 100mg+250ml normal saline (NS)
干预措施: Ganglioside-Monosialic Acid (Drug)
Control group
standard (neo)adjuvant chemotherapy plus 250ml normal saline (NS)
干预措施: 250ml normal saline (NS) (Drug)
结局指标
主要结局
HVLT R-DR
时间窗: 4 weeks after the completion of adjuvant chemotherapy
The change of score for Hopkins verbal learning test -revised,delayed recall,from baseline to 4 weeks after the completion of adjuvant chemotherapy.
次要结局
- ADAS-Cog(36 weeks after the completion of adjuvant chemotherapy)
- HVLT R-DR(36 weeks after the completion of adjuvant chemotherapy)
研究者
Zhong-yu Yuan
Professor
Sun Yat-sen University