Clinical Significance of Change in Body Weight During Treatment of Advanced Colorectal Cancer Patients - A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Colorectal cancer (CRC) is a significant and growing health burden in Hong Kong. According to data from Hong Kong Cancer Registry, CRC ranked the first in incidence and the second in mortality, with around 5,000 new cases diagnosed and more than 2,000 cancer-related mortality in 2014. The investigators aim to evaluate the association between serial weight change during first line treatment and outcomes in patients with metastatic CRC.
详细描述
Studies have suggested that exposure to a greater number of chemotherapeutic agents is associated with better survival in metastatic colorectal cancer.
Multiple factors might affect body weight during treatment. Cancer-related symptoms can impair quality of life and appetite. Cachexia syndrome affects around 50% of colon cancer patients and is characterized by cancer-induced catabolism with involuntary weight loss (fat and muscle), patients have increased lipolysis and change in skeletal muscle metabolism, including increased energy expenditure at rest and protein degradation, and decreased protein synthesis. Besides these disease factors, treatment related side effects are common causes of weight loss, such as inability to ingest or digest food effectively due to nausea, vomiting, and malaise. Based on these factors and the hypotheses between tumour control and weight gain, monitoring the serial weight change can have practical value.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Histologically proven adenocarcinoma of colorectal origin
- •Stage IV disease with systemic treatment
- •Estimated life expectancy >3 months
- •Adequate organ functions
排除标准
- •Eastern Cooperative Oncology Group performance status 3 or above
- •Pregnancy
- •Human immunodeficiency virus infection and acquired immune deficiency syndrome (HIV/AIDS)
- •Past medical history of another cancer
研究组 & 干预措施
stage IV colorectal cancer
stage IV colorectal cancer on first line systemic treatment are observed for the trend of weight change and treatment outcomes
干预措施: first line systemic treatment for colorectal cancer (Drug)
结局指标
主要结局
Overall survival
时间窗: From date of start of anti-cancer treatment until the date of death from any cause (assessed by physical examination, imaging, or blood biomarkers), assessed up to 60 months
Survival time from start of anti-cancer treatment until death from any cause, or loss of follow-up
Progression-free survival
时间窗: From date of start of anti-cancer treatment until the date of first documented progression (assessed by physical examination, imaging, or blood biomarkers) or date of death from any cause, whichever came first, assessed up to 60 months
Survival time from start of anti-cancer treatment until disease progression, or death from disease, or loss of follow-up
次要结局
- Chemotherapy interruption(from start of first-line anti-cancer treatment until completion, assessed by clinical assessment up to 60 months)
- Chemotherapy dose change(from start of first-line anti-cancer treatment until completion, assessed by clinical assessment up to 60 months)
研究者
Shing Fung Lee
Resident Specialist
Tuen Mun Hospital