Biological Markers In Patients With Pancreatic Cancer Experiencing Weight Loss

Study Overview

Biological Markers in Patients With Pancreatic Cancer Experiencing Weight Loss

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.

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.

Cachexia
Pancreatic Cancer

OTHER: immunologic technique
OTHER: laboratory biomarker analysis
PROCEDURE: biopsy

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

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-05-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-09-29
First Submitted that Met QC Criteria 2009-05-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-09-30
First Posted (ESTIMATED) 2009-05-12	Results First Posted N/A	Last Verified 2015-09

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

ECOG performance status 0-3
Life expectancy ≥ 12 weeks
No pacemakers or implanted defibrillators

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

Collaborators and Investigators

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

National Cancer Institute (NCI)

Investigators

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

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record