Changes in Muscle Tissue in Patients With Pancreatic Cancer
NCT ID: NCT00369460
Last Updated: 2015-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
9 participants
OBSERVATIONAL
2006-01-31
2009-07-31
Brief Summary
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PURPOSE: This pilot study is evaluating changes in muscle tissue in patients with pancreatic cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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physiologic testing
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 Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Joanna M. Brell, MD
Role: PRINCIPAL_INVESTIGATOR
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Locations
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Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CASE8205
Identifier Type: OTHER
Identifier Source: secondary_id
CASE8205
Identifier Type: -
Identifier Source: org_study_id
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