Biological Markers in Patients With Pancreatic Cancer Experiencing Weight Loss

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00899158
First received: May 9, 2009
Last updated: June 10, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention
Cachexia
Pancreatic Cancer
Other: immunologic technique
Other: laboratory biomarker analysis
Procedure: biopsy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Skeletal muscle loss [ Designated as safety issue: No ]
  • Lean body mass [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Caspase-3 levels [ Designated as safety issue: No ]
  • Phosphorylated Akt levels [ Designated as safety issue: No ]
  • Urinary 3-methylhistidine levels [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

During surgery, a muscle biopsy is performed and approximately 1 cm of rectus abdominous muscle is obtained for analysis.


Enrollment: 44
Study Start Date: June 2005
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinic

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899158

Locations
United States, Ohio
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Joanna M. Brell, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Joanna Brell, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00899158     History of Changes
Other Study ID Numbers: CASE3204, P30CA043703, CASE3204, CWRU-020541
Study First Received: May 9, 2009
Last Updated: June 10, 2010
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
recurrent pancreatic cancer
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer
cachexia

Additional relevant MeSH terms:
Cachexia
Pancreatic Neoplasms
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 14, 2014