Changes in Muscle Tissue in Patients With Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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. PROJECTED ACCRUAL: A total of 17 patients will be accrued for this study.

Official Title
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Pilot Study of Changes in Fat-Free Mass in Pancreatic Carcinoma Patients

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Other: physiologic testing


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Biopsy-proven inoperable locally advanced or metastatic pancreatic adenocarcinoma PATIENT CHARACTERISTICS: ECOG performance status 0-3 Must be able to stand unassisted on a scale Must not have pacemaker or implanted defibrillator PRIOR CONCURRENT THERAPY: Prior chemotherapy or radiotherapy allowed No concurrent use of any of the following: Corticosteroids Steroids as anti-emetics associated with chemotherapy allowed Anabolic steroids Thalidomide Megesterol Eicosapentaenoic acid (EPA) Nutritional supplements without EPA allowed Juven Concurrent enrollment in other clinical trials allowed
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: physiologic testing|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat-free mass (FFM) |  | 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 |  | at 6 months | 
| Incidence of lymphocytopenia |  | 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 |  | at 6 months | 
| Collection of information on weight, body mass index, age, ECOG performance status, gait speed, concomitant medications, CA19-9, and total lymphocyte count |  | At start of cancer treatment and re-assessed at approximately 2 months, 4 months, 6 months, and with any change in tumor burden. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer