Changes in Muscle Tissue in Patients With Pancreatic Cancer

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Pancreatic Cancer

Treatments: Other: physiologic testing

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00369460

P30CA043703 (U.S. NIH Grant/Contract)

CASE8205 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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