Role of Caspase-3, Phosphatidylinositol-3 Kinase (PI3K), and 3-methylhistidine (3-MH) in the Pathophysiology of Skeletal Muscle Loss in Weight-losing Pancreas Cancer Patients
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.
Description
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.
Status: Completed (N/A). Started on June 1st, 2005.
Enrollment: 44 subjects
Study Type: Observational
Study Design:
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
Conditions:
Interventions:
- Other: immunologic technique
- Other: laboratory biomarker analysis
- Procedure: biopsy
Eligibility
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
- Gender
Both
- Mininum Age
18 Years
- Maximum Age
N/A
- Healthy Volunteers
No
Resources
Source: Case Comprehensive Cancer Center
Authority: United States: Federal Government
Locations
-
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland
Ohio
44106
United States
Officials
Joanna M. Brell, MD (Study Chair, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center)
Sponsors
Case Comprehensive Cancer Center (Lead Sponsor)
National Cancer Institute (NCI) (Collaborator)
References
None.
Links
- Date Verified
- June 1st, 2010
- First Received
- June 10th, 2010
- Last Changed
- June 10th, 2010
Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.
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