Biological Markers in Patients With Pancreatic Cancer Experiencing Weight Loss

Case Comprehensive Cancer Center44 enrolled

Overview

RATIONALE: Learning about biological markers in patients with pancreatic cancer and cachexia may help doctors predict patient outcome and may help the study of cancer in the future. PURPOSE: This laboratory study is examining biological markers in patients with pancreatic cancer experiencing weight loss.

OBJECTIVES: * Compare levels of caspase-3 and phosphorylated Akt (pAkt) in the rectus abdominous muscle of patients with pancreatic cancer who are experiencing cachexia and are undergoing surgery for diagnosis or primary therapy with patients who have not lost weight and are undergoing abdominal surgery for nonmalignant conditions. * Compare levels of urinary 3-methylhistidine (3-MH) in these patients. * Evaluate possible correlations of caspase-3 activity, pAkt, and urinary 3-MH with early time to progression and subsequent lean body weight loss in patients with pancreatic cancer. * Associate excretion of urinary 3-MH with higher levels of caspase-3 activity and pAkt to analyze the utility of 3-MH as a marker of skeletal muscle proteolysis. OUTLINE: This is a pilot study. During surgery, a muscle biopsy is performed and approximately 1 cm of rectus abdominous muscle is obtained for analysis. Caspase-3 activity and total/phosphorylated phosphatidylinositol-3 kinase and Akt are measured in muscle biopsies by western blot analysis. 3-methylhistidine activity is measured in urine samples. After completion of study, patients with pancreatic cancer are followed postoperatively at 3 and 6 months. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cachexia Pancreatic Cancer

Interventions

immunologic techniqueOTHER

laboratory biomarker analysisOTHER

biopsyPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * Diagnosis or suspicion of pancreatic cancer * Any stage disease allowed * At least 5% weight loss within the past 6 months * Scheduled to undergo exploratory surgery * Scheduled to undergo exploratory surgery for suspected nonmalignant condition * No weight loss OR weight loss due to specific reason (e.g., bowel obstruction, infection, or nausea/vomiting) * No cancer diagnosis other than primary pancreatic carcinoma PATIENT CHARACTERISTICS: * ECOG performance status 0-3 * Life expectancy ≥ 12 weeks * No pacemakers or implanted defibrillators PRIOR CONCURRENT THERAPY: * Prior or concurrent chemotherapy and radiotherapy allowed * Prior or concurrent biological therapy and surgery allowed * At least 4 weeks since prior corticosteroids or anabolic steroids * Other concurrent anticancer therapy allowed * No concurrent corticosteroids or anabolic steroids, thalidomide, eicosapentaenoic acid (EPA), or Juven for weight loss * Concurrent steroids (i.e., antiemetics) associated with chemotherapy allowed * No concurrent nutritional supplements with EPA

Locations (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Skeletal muscle loss

Time frame: Up to 6 months

Lean body mass

Time frame: Up to 6 months

Time to progression

Time frame: Up to 6 months

Caspase-3 levels

Time frame: Up to 6 months

Phosphorylated Akt levels

Time frame: Up to 6 months

Urinary 3-methylhistidine levels

Time frame: Up to 6 months

Data from ClinicalTrials.gov

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