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临床试验/NCT00502502
NCT00502502已完成不适用

Feasibility Study of the Assessment of Symptom-Related Cytokines in Lung and GI Cancer Patients Undergoing Chemoradiation Therapy

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2002年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
205
试验地点
1
主要终点
Patient Symptom Assessment (Questionnaire)

研究概览

简要总结

Primary Objectives:

  • To determine the feasibility of a study that would describe changes of certain circulating inflammatory cytokines (interleukin-1, 6, 8, 10, 12, and tumor necrosis factor-alpha [TNF] and symptoms related to chemoradiation therapy (pre-therapy, during therapy and up to 3 months post-therapy) among patients with lung, esophageal, gastric, colorectal and anal cancer.
  • To determine the feasibility of studying neurocognitive function in patients with non-small cell lung cancer (NSCLC) at presentation and during chemoradiation therapy to determine the prevalence, severity, and pattern of cognitive symptoms.

详细描述

One of the ways to learn about the symptoms of chemoradiation therapy is by looking at how certain proteins called cytokines (found in the blood) change during therapy. Another way is to look at how thinking and memory may be changed because of treatment.

Before therapy starts, you will be asked to complete several questionnaires during a visit to the Radiation Oncology clinic at M. D. Anderson. These questionnaires measure physical and emotional symptoms. These questionnaires should take about 30 minutes to finish. Lung cancer patients will also complete some cognitive (mental) questionnaires. During this visit, the research nurse will teach you how to use the telephone system for measuring symptoms. You will tell the system the most convenient times for the telephone calls. The date of the call will be at the same or close to the date of your weekly clinic visit.

Before you begin your chemoradiation treatments, you will have a sample of blood drawn (around 2½ tablespoons). The sample of blood will be used to measure levels of cytokines in your blood pre treatment.

You will have about 2½ tablespoons of blood drawn again when you start chemoradiation, and then once a week while you are receiving treatment. These cytokines may be related to symptoms experienced while having treatment for cancer. These blood tests are being done to study the levels of cytokines in your blood during, and after treatment for cancer.

Symptoms will be monitored weekly using an interactive voice response telephone system. During chemoradiation, the automated telephone system will call you once a week to ask you to rate your symptoms and how much the symptoms interfere in your daily life. The information collected by these calls is only being used for this research study.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Patients scheduled for chemoradiation therapy at MDACC.
  • Adults > 18 years of age.
  • Diagnosis of lung, esophageal, gastric, colorectal, or anal cancer.
  • English-speaking.
  • Lives in the United States.
  • Adequate vision and hearing to use the IVR system.
  • Provides written informed consent.

排除标准

  • Patients with a current diagnosis of psychosis or dementia.
  • Patients who are unable to complete the assessment measures or refuse to participate.

结局指标

主要结局

Patient Symptom Assessment (Questionnaire)

时间窗: Weekly for 1-3 months post-therapy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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