Changes in Muscle Tissue in Patients With Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT00369460
- Lead Sponsor
- Case Comprehensive Cancer Center
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Collection of information on weight, body mass index, age, ECOG performance status, gait speed, concomitant medications, CA19-9, and total lymphocyte count At start of cancer treatment and re-assessed at approximately 2 months, 4 months, 6 months, and with any change in tumor burden. Incidence of lymphocytopenia Total lymphocyte count measured before start of cancer treatment and at approximately 2 months, 4 months, 6 months, and with any change in tumor burden. Correlation of pretreatment total lymphocyte count, treatment response, and survival at 6 months at 6 months Fat-free mass (FFM) Patients will have body mass index 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. Correlation of changes in FFM with survival at 6 months at 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States