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Biological Markers in Patients With Pancreatic Cancer Experiencing Weight Loss

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00899158
First Posted: May 12, 2009
Last Update Posted: September 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
  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 [ 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
Investigators
Study Chair: Joanna M. Brell, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  More Information

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00899158     History of Changes
Other Study ID Numbers: CASE3204
P30CA043703 ( U.S. NIH Grant/Contract )
CASE3204 ( Other Identifier: Case Comprehensive Cancer Center )
CWRU-020541
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: September 30, 2015
Last Verified: September 2015

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:
Pancreatic Neoplasms
Cachexia
Wasting Syndrome
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders