Healia Clinical Trials Information Database

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.


All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.

The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


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