Assessment of Symptom-Related Cytokines in Lung and Gastrointestinal (GI) Cancer Patients

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Brief Title

Assessment of Symptom-Related Cytokines in Lung and Gastrointestinal (GI) Cancer Patients

Official Title

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

Brief Summary

      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.
    

Detailed Description

      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.

      At the end of the chemoradiation, lung cancer patients will again be given questionnaires to
      measure cognitive symptoms.

      For lung cancer patients who are post-chemotherapy, your symptoms will be monitored weekly
      for 3 months after therapy using the interactive voice response telephone system. For
      esophageal, gastric, colorectal, and anal patients who are post-therapy, your symptoms will
      be monitored weekly for 6 weeks after therapy using the interactive voice response telephone
      system. About 30 days after chemoradiation, you will have 2½ tablespoons of blood drawn at
      your regularly scheduled clinic visit. If you are not scheduled for a 3 month clinic visit,
      we will contact your local physician for blood lab results.

      This is an investigational study. About 225 evaluable patients will take part in this study.
      All will be enrolled at M. D. Anderson.
    


Study Type

Observational


Primary Outcome

Patient Symptom Assessment (Questionnaire)


Condition

Anal Cancer

Intervention

Questionnaire

Study Arms / Comparison Groups

 Symptom-Related Cytokines Questionnaire
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

205

Start Date

November 2002

Completion Date

July 2010

Primary Completion Date

July 2010

Eligibility Criteria

        Inclusion Criteria:

          1. Patients scheduled for chemoradiation therapy at MDACC.

          2. Adults > 18 years of age.

          3. Diagnosis of lung, esophageal, gastric, colorectal, or anal cancer.

          4. English-speaking.

          5. Lives in the United States.

          6. Adequate vision and hearing to use the IVR system.

          7. Provides written informed consent.

        Exclusion Criteria:

          1. Patients with a current diagnosis of psychosis or dementia.

          2. Patients who are unable to complete the assessment measures or refuse to participate.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Xin Shelley Wang, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00502502

Organization ID

ANS02-495


Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Xin Shelley Wang, MD, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

July 2012