Pilot Study of Changes in Fat-Free Mass in Pancreatic Carcinoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Collection of information on weight, body mass index, age, ECOG performance status, gait speed, concomitant medications, CA19-9, and total lymphocyte count
研究概览
简要总结
RATIONALE: Measuring changes in muscle tissue in patients with cancer may help doctors predict how well patients will respond to treatment, and may help the study of cancer in the future.
PURPOSE: This pilot study is evaluating changes in muscle tissue in patients with pancreatic cancer.
详细描述
OBJECTIVES:
- Demonstrate a decrease/increase of fat-free mass (FFM) by 10% from baseline, based on tumor progression/regression, within each patient with inoperable locally advanced or metastatic pancreatic carcinoma.
- Determine the correlation between changes in FFM and 6-month survival.
- Confirm the frequency of lymphocytopenia in patients with inoperable locally advanced or metastatic pancreatic carcinoma.
- Demonstrate an interaction between pretreatment total lymphocyte count, treatment response, and 6-month survival in patients with inoperable locally advanced or metastatic pancreatic carcinoma.
- Collect adjuvant information, such as weight, body mass index, age, ECOG performance status, gait speed, concomitant medications, CA19-9, and total lymphocyte count, in these patients.
OUTLINE: This is a pilot study.
Patients will have weight, body mass index, age, ECOG performance status, gait speed, concomitant medications, CA19-9, and total lymphocyte count measured before start of cancer treatment of the patient's choosing.
Patients will be re-assessed at approximately 2 months, 4 months, 6 months, and with any change in tumor burden.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 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
结局指标
主要结局
Collection of information on weight, body mass index, age, ECOG performance status, gait speed, concomitant medications, CA19-9, and total lymphocyte count
时间窗: At start of cancer treatment and re-assessed at approximately 2 months, 4 months, 6 months, and with any change in tumor burden.
Incidence of lymphocytopenia
时间窗: Total lymphocyte count measured before start of cancer treatment and at approximately 2 months, 4 months, 6 months, and with any change in tumor burden.
Correlation of pretreatment total lymphocyte count, treatment response, and survival at 6 months
时间窗: at 6 months
Fat-free mass (FFM)
时间窗: Patients will have body mass index measured before start of cancer treatment of the patient's choosing. Patients will be re-assessed at approximately 2 months, 4 months, 6 months, and with any change in tumor burden.
Correlation of changes in FFM with survival at 6 months
时间窗: at 6 months
次要结局
未报告次要终点