Biological Markers in Patients With Pancreatic Cancer Experiencing Weight Loss

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00899158
• Other study ID #: CASE3204
• Secondary ID: P30CA043703CASE3
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: September 29, 2015
• Start date: June 2005
• Est. completion date: December 2008

Study information

• Verified date: September 2015
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cachexia
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Other:
• immunologic technique

• laboratory biomarker analysis

Procedure:
• biopsy

Locations

Country	Name	City	State
United States	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skeletal muscle loss		Up to 6 months	No
Primary	Lean body mass		Up to 6 months	No
Primary	Time to progression		Up to 6 months	No
Primary	Caspase-3 levels		Up to 6 months	No
Primary	Phosphorylated Akt levels		Up to 6 months	No
Primary	Urinary 3-methylhistidine levels		Up to 6 months	No