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OpenTrials
Completed

NCT Number: NCT00899158

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

immunologic technique

Other

laboratory biomarker analysis

Other

Biopsy

Procedure

Primary outcomes

  1. Skeletal muscle loss

    Time frame: Up to 6 months

  2. Lean body mass

    Time frame: Up to 6 months

  3. Time to progression

    Time frame: Up to 6 months

  4. Caspase-3 levels

    Time frame: Up to 6 months

  5. Phosphorylated Akt levels

    Time frame: Up to 6 months

  6. Urinary 3-methylhistidine levels

    Time frame: Up to 6 months

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
May 12, 2009
Registry last updated
Sep 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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