Changes in Muscle Tissue in Patients With Pancreatic Cancer

Case Comprehensive Cancer Center9 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pancreatic Cancer

Interventions

physiologic testingOTHER

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

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

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Fat-free mass (FFM)

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.

Correlation of changes in FFM with survival at 6 months

Time frame: at 6 months

Incidence of lymphocytopenia

Time frame: 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

Time frame: at 6 months

Collection of information on weight, body mass index, age, ECOG performance status, gait speed, concomitant medications, CA19-9, and total lymphocyte count

Time frame: At start of cancer treatment and re-assessed at approximately 2 months, 4 months, 6 months, and with any change in tumor burden.

Data from ClinicalTrials.gov

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