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
18 Years
N/A
Both
Cachexia, Pancreatic Cancer
Trial Information
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
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.
Inclusion Criteria
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Outcome Measure:
Skeletal muscle loss
Safety Issue:
No
Principal Investigator
Joanna M. Brell, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CASE3204
NCT ID:
NCT00899158
Start Date:
June 2005
Completion Date:
December 2008
Related Keywords:
- Cachexia
- Pancreatic Cancer
- recurrent pancreatic cancer
- stage I pancreatic cancer
- stage II pancreatic cancer
- stage III pancreatic cancer
- stage IV pancreatic cancer
- cachexia
- Cachexia
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
