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Evaluation of Intensive Pancreatic Proteolytic Enzyme Therapy With Ancillary Nutritional Support Versus Gemcitabine Chemotherapy in the Treatment of Inoperable Pancreatic Adenocarcinoma (NCT00003851)

National Center for Complementary and Integrative Health (NCCIH)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Pancreatic enzymes may help kill cancer cells. It is not yet known if gemcitabine is more effective than pancreatic enzyme therapy plus specialized diet for pancreatic cancer. PURPOSE: This clinical trial is comparing the effectiveness of gemcitabine with that of pancreatic enzyme therapy plus specialized diet (Gonzalez regimen) in treating patients who have stage II, stage III, or stage IV pancreatic cancer.
  • Biological: proteolytic enzymes
    • Drug: gemcitabine hydrochloride
      • Procedure: Gonzalez regimen
        Ages eligible for Study
        18 Years to 65 Years
        Genders eligible for Study
        All
        Accepts Healthy Volunteers
        No
        OBJECTIVES:

        - Compare the survival of patients with stage II, III, or IV adenocarcinoma of the pancreas treated with gemcitabine versus intensive proteolytic enzyme therapy and adjunctive dietary and nutritional support.

        - Compare the quality of life in patients treated with these regimens.

        OUTLINE: This is an open-label study. Patients are stratified according to stage (II or III vs IV), performance status (0-1 vs 2) and nutritional status (well nourished or moderately malnourished vs severely malnourished). Patients are entered into 1 of 2 treatment arms at their choice:

        - Arm I (Nutritional Arm): Patients receive pancreatic enzymes orally every 4 hours and at meals daily on days 1-16, followed by 5 days of rest. Patients receive magnesium citrate and Papaya Plus with the pancreatic enzymes. Additionally, patients receive nutritional supplementation with vitamins, minerals, trace elements, and animal glandular products 4 times per day on days 1-16, followed by 5 days of rest. Courses repeat every 21 days until death despite relapse. Patients consume a moderate vegetarian metabolizer diet during the course of therapy, which excludes red meat, poultry, and white sugar. Coffee enemas are performed twice a day, along with skin brushing daily, skin cleansing once a week with castor oil during the first 6 months of therapy, and a salt and soda bath each week. Patients also undergo a complete liver flush and a clean sweep and purge on a rotating basis each month during the 5 days of rest.

        - Arm II (Chemotherapy Arm): Patients receive gemcitabine-based chemotherapy. Quality of life is assessed at 0, 2, 6, and 12 months and then yearly thereafter.

        Patients are followed at 1, 3, 7, and 12 months and then yearly thereafter.

        PROJECTED ACCRUAL: Approximately 72-90 patients will be accrued for this study within 3 years.

        1 locations

        United States (1)
        • Herbert Irving Comprehensive Cancer Center at Columbia University
          New York, New York, United States, 10032
        Status:
        terminated
        Type:
        Interventional
        Phase:
        -
        Start:
        28 February, 1999
        Updated:
        12 February, 2013
        Participants:
        90
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