Pilot Study of Changes in Fat-Free Mass in Pancreatic Carcinoma Patients
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.
Observational
Observational Model: Cohort, Time Perspective: Prospective
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.
No
Joanna M. Brell, MD
Principal Investigator
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
CASE8205
NCT00369460
January 2006
July 2009
Name | Location |
---|---|
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |