Biological Markers in Patients With Pancreatic Cancer Experiencing Weight Loss

September 29, 2015 updated by: Case Comprehensive Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Skeletal muscle loss
Time Frame: Up to 6 months
Up to 6 months
Lean body mass
Time Frame: Up to 6 months
Up to 6 months
Time to progression
Time Frame: Up to 6 months
Up to 6 months
Caspase-3 levels
Time Frame: Up to 6 months
Up to 6 months
Phosphorylated Akt levels
Time Frame: Up to 6 months
Up to 6 months
Urinary 3-methylhistidine levels
Time Frame: Up to 6 months
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Joanna M. Brell, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (ACTUAL)

November 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (ESTIMATE)

May 12, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 30, 2015

Last Update Submitted That Met QC Criteria

September 29, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE3204 (OTHER: Case Comprehensive Cancer Center)
  • P30CA043703 (U.S. NIH Grant/Contract)
  • CWRU-020541

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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