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Home > "S" Clinical Trials Conditions > Study to treat Cancer-Related Cachexia in Patients with Pancreatic Cancer  Study to treat Cancer-Related Cachexia in Patients with Pancreatic Cancer
Study to treat Cancer-Related Cachexia in Patients with Pancreatic Cancer
For Condition: Pancreatic Neoplasms,Cachexia
Status: Recruiting
Sponsor(s): Centocor ,
Synopsis: Cachexia is a condition that occurs in cancer patients and other chronically ill patients and is characterized by rapid loss of fatty tissue and skeletal muscle. The key feature of this condition is weight loss, but other symptoms, such as anorexia (loss of appetite), fatigue, vomiting and anemia (low numbers of red blood cells) may also occur. Patients with pancreatic cancer have among the highest rate of weight loss of any group of patients with cancer, with approximately 80 to 90% losing weight during the course of their illness. Some research studies have shown that a substance called tumor necrosis factor alpha or TNFa is one of the important factors contributing to cancer-related cachexia. The medication being used in this study decreases the amount of TNFa in the blood. It is thought that using this drug might delay or stop the progression of cachexia. A total of approximately 90 patients across approximately 23 centers throughout the world will participate in this study.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Documented (biopsy-confirmed) pathologic diagnosis of pancreatic cancer that is newly diagnosed, locally advanced, or metastatic (Stage II to IV) and is not amenable to surgical resection. - Standard gemcitabine chemotherapy is indicated. - Documented loss of >/= 10% body weight compared to premorbid stable weight, or >/= 5% weight loss within 90 days prior to randomization. - Karnofsky performance status of 70 to 100. - Adequate bone marrow, liver and renal functions. Exclusion Criteria - Received any previous chemotherapy, biologic therapy or radiation therapy, for pancreatic cancer. - Pregnant, nursing or planning pregnancy. - Ongoing use of tube feedings or TPN. - BMI >/= 28 - Receiving any medication that can profoundly modulate metabolism or weight. - Mechanical obstruction of the alimentary or biliary tract, malabsorption, or intractable vomiting or diarrhea. - Evidence of congestive heart failure (CHF) or clinical history of CHF.
Total Enrollment: 90
Location and Contact Information:
Arizona Cancer Center *Recruiting*
Tucson, Arizona, 25724
United States
Recruiting
New York Oncology Hematology PC *Recruiting*
Albany, New York,
United States
Recruiting
C. Micheal Jones, MD - Hematology/Oncology *Recruiting*
Germantown, Tennessee,
United States
Recruiting
Ultimate Health Services, Inc. *Recruiting*
Huntington, West Virginia, 25702
United States
Recruiting
Rocky Mountain Cancer Center *Recruiting*
Denver, Colorado,
United States
Recruiting
Medical College of Wisconsin *Recruiting*
Milwakee, Wisconsin, 53226
United States
Recruiting
New York Medical College *Recruiting*
Valhalla, New York,
United States
Recruiting
Pacific Coast Hem/Onc Medical Group, Inc. *Recruiting*
Fountain Valley, California,
United States
Recruiting
University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting
Capitol Comprehensive Cancer Care Clinic *Recruiting*
Jefferson City, Missouri, 65109
United States
Recruiting
Arizona Cancer Center *Recruiting*
Scottsdale, Arizona, 85258
United States
Recruiting
Central Indiana Cancer Centers *Recruiting*
Indianapolis, Indiana, 46227
United States
Recruiting
Additional Information:
Study ID Numbers: CO168T60;
Study Start Date: February 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060502
Other Cachexia Studies:
1. Creatine in Treating Patients With Cancer-Associated Weight Loss
2. Comparison of Nutritional Supplements in Preventing Weight Loss in Patients With Cancer
3. Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite
4. Adenosine Triphosphate in Treating Patients With Advanced Solid Tumors
5. Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/day, and Placebo in AIDS Patients With Anorexia and Cachexia
Related Studies:
Other Cachexia Clinical Trials
Other California Clinical Trials
Other Fountain Valley Clinical Trials
Study to treat Cancer-Related Cachexia in Patients with Pancreatic Cancer
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