NCT00369460

Changes in Muscle Tissue in Patients With Pancreatic Cancer

Pilot Study of Changes in Fat-Free Mass in Pancreatic Carcinoma Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 9 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: Measuring changes in muscle tissue in patients with cancer may help doctors predict how well patients will respond to treatment, and may help the study of cancer in the future. PURPOSE: This pilot study is evaluating changes in muscle tissue in patients with pancreatic cancer.

Detailed description

OBJECTIVES: * Demonstrate a decrease/increase of fat-free mass (FFM) by 10% from baseline, based on tumor progression/regression, within each patient with inoperable locally advanced or metastatic pancreatic carcinoma. * Determine the correlation between changes in FFM and 6-month survival. * Confirm the frequency of lymphocytopenia in patients with inoperable locally advanced or metastatic pancreatic carcinoma. * Demonstrate an interaction between pretreatment total lymphocyte count, treatment response, and 6-month survival in patients with inoperable locally advanced or metastatic pancreatic carcinoma. * Collect adjuvant information, such as weight, body mass index, age, ECOG performance status, gait speed, concomitant medications, CA19-9, and total lymphocyte count, in these patients. OUTLINE: This is a pilot study. Patients will have weight, body mass index, age, ECOG performance status, gait speed, concomitant medications, CA19-9, and total lymphocyte count measured before start of cancer treatment of the patient's choosing. Patients will be re-assessed at approximately 2 months, 4 months, 6 months, and with any change in tumor burden. PROJECTED ACCRUAL: A total of 17 patients will be accrued for this study.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
OTHER	physiologic testing	Weight, body mass index, age, ECOG performance status, gait speed, concomitant medications, CA19-9, and total lymphocyte count measured before start of cancer treatment of the patient's choosing. Patients will be re-assessed at approximately 2 months, 4 months, 6 months, and with any change in tumor burden.

Timeline

• Start date: 2006-01-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2006-08-29
• Last updated: 2015-10-12

Locations

1 site across 1 country: United States