Effects on QOL When Zinc is Supplemented in Patients With Upper GI Cancer on Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- Quality of life scores
研究概览
简要总结
This randomized study examines how well zinc works in improving quality of life in patients with gastrointestinal cancer that cannot be removed by surgery who are receiving chemotherapy. Zinc may help to improve patient's quality of life by preventing zinc deficiency.
详细描述
PRIMARY OBJECTIVE:
I. Assess the effects on quality of life (QOL) when supplementing zinc in upper gastrointestinal (GI) cancer patients while they are receiving chemotherapy.
SECONDARY OBJECTIVES:
I. Correlate hypoalbuminemia with serum zinc deficiency.
II. Correlate zinc deficiency with neutropenia.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who present to adult medical oncology outpatient clinic with new diagnosis of non-resectable gastric, gastro-esophageal, pancreas or biliary cancer
- •Patients plan to receive chemotherapy at an Emory Cancer Center
- •No prior chemotherapy or radiation therapy for newly diagnosed gastric, gastro-esophageal, pancreas or biliary cancer
- •Patients must sign informed consent
排除标准
- •Zinc supplementation is not indicated for pregnant or lactating women therefore, this is an exclusion criteria and women of childbearing age will complete a pregnancy test
结局指标
主要结局
Quality of life scores
时间窗: Up to 4 months after study start
Quality of life (QOL) will be evaluated through patient subjective responses to the QOL survey.
次要结局
- Serum albumin level(Up to 4 months after study start)
- Serum zinc level(Up to 4 months after study start)
研究者
Olatunji Alese
Principal Investigator
Emory University