Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT00003851
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT00003851
Study Brief:
Protocol Section:
NCT00003851