Evaluation of Intensive Pancreatic Proteolytic Enzyme Therapy With Ancillary Nutritional Support Versus Gemcitabine Chemotherapy in the Treatment of Inoperable Pancreatic Adenocarcinoma
- 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
- 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
- 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
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
John Chabot, MD
Herbert Irving Comprehensive Cancer Center
United States: Institutional Review Board
|Herbert Irving Comprehensive Cancer Center at Columbia University||New York, New York 10032|