Changes in Muscle Tissue in Patients With Pancreatic Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2006 |
| End Date: | July 2009 |
Pilot Study of Changes in Fat-Free Mass in Pancreatic Carcinoma Patients
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.
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.
- 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.
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
We found this trial at
1
site
Cleveland, Ohio 44106
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