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


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Not Enrolling
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Pancreatic Cancer

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Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Biopsy-proven inoperable locally advanced or metastatic pancreatic adenocarcinoma

PATIENT CHARACTERISTICS:

- ECOG performance status 0-3

- Must be able to stand unassisted on a scale

- Must not have pacemaker or implanted defibrillator

PRIOR CONCURRENT THERAPY:

- Prior chemotherapy or radiotherapy allowed

- No concurrent use of any of the following:

- Corticosteroids

- Steroids as anti-emetics associated with chemotherapy allowed

- Anabolic steroids

- Thalidomide

- Megesterol

- Eicosapentaenoic acid (EPA)

- Nutritional supplements without EPA allowed

- Juven

- Concurrent enrollment in other clinical trials allowed

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Fat-free mass (FFM)

Outcome Time Frame:

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.

Safety Issue:

No

Principal Investigator

Joanna M. Brell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Federal Government

Study ID:

CASE8205

NCT ID:

NCT00369460

Start Date:

January 2006

Completion Date:

July 2009

Related Keywords:

  • Pancreatic Cancer
  • recurrent pancreatic cancer
  • stage III pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065