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Study Summary
No. 2008-0582:.......Pancreas......Xin Shelley Wang......Symptom Research
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Study Summary Title
Study Summary
Number:		2008-0582
Study Title:A feasibility study for identifying the role of symptom outcomes and biomarkers in survival of patients with pancreatic cancer
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Physician New Patient Referral
Name:Xin Shelley WangPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Symptom ResearchReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-3504
Contact us about clinical trials
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General Information
Disease Group:PancreasSupported By:N/A
Phase of Study:N/AReturn
Visit:		We expect to meet patients during their routine clinic visit to GI medical
oncologist before the second cycle of chemotherapy, as well as at 2 months and
4 months from start of chemotherapy.
Treatment
Agents:		NoneHome Care:None planned.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		Patients will be followed for their multiple symptoms up to 18 months or until
death. The study does not require hospitalization.
Description/
Intervention:		The goal of this clinical research study is to learn about symptoms related to
chemotherapy and the disease, in patients with advanced pancreatic cancer.
Researchers will study the possible reason for these symptoms by drawing blood
samples and comparing the test results to the symptoms you experience. The
study will also use a special telephone system for measuring the symptoms of
participants during and after therapy. Your level of physical activity will
also be studied using a pedometer and study diary.
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Study Objectives / Outcomes
1.1 Primary
1.1.1. To determine the value of patient reported pain and other symptoms for predicting overall survival in pancreatic cancer patients.
    1.2. Secondary
    1.2.1. To categorize, by using the patient rated multiple symptom assessment tool MD Anderson Symptom Inventory (MDASI), the longitudinal course of the multiple symptoms experienced by pancreatic cancer patients with metastatic disease.

    1.2.2. To explore the relationships between cancer symptoms and polymorphisms of genes relating to inflammation, chemotherapeutic drug and opiate metabolism.
      1.2.3. To explore the association of inflammatory cytokines, such as IL-6 and TNF-alpha, with disease-driven symptom development and its predictive value for survival in pancreatic cancer patients.

      1.2.4. To evaluate the association between objective measures of physical function (via daily step count), component scores of patient reported physical symptom severity, and physician reported performance status (ECOG PS).
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      Study Status Information
      Study Activation / Registration Date:11/12/2008
      IRB Review and Approval Date:11/12/2008
      Study Type:Observational
      Recruitment Status:Closed
      Projected Accrual:N/A
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      Enrollment Eligibility
      If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
      Inclusion Criteria:1) Patients must have histologically or cytologically confirmed cancer of the pancreas.

      2) Patients must have inoperable locally advanced or metastatic disease.

      3) Patients could be on treatment, or being planned for chemotherapy treatment.

      4) Age 18 years of age or older

      5) ECOG performance status 0-3

      6) Ability to give consent in either English or Spanish
      Exclusion Criteria:1) Any condition (including unwillingness) that would impair the patient's ability to utilize the IVR system

      2) Any recent surgical procedures (within 14 days, excluding biopsy, port-a-cath or picc line placement)
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      Links
      Registration Number: NCT00805688
      Study Information on Clinical Trials Registry (clinicaltrials.gov)
      Other Links:
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      Results

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