Innovative Clinical Trial for Advanced Pancreatic Cancer Patients

NEW YORK—An innovative clinical trial to be conducted at Columbia University is now recruiting patients with advanced pancreatic cancer. The study will test the effectiveness of the “Gonzalez regimen,” which combines a strict diet of fresh fruits, vegetable juices, dietary supplements, and pancreatic enzyme extracts with a “detoxification” program. John Chabot, MD, a surgical oncologist at Columbia-Presbyterian Cancer Center, is the principal investigator.

The researchers are seeking 72 to 90 patients with advanced pancreatic cancer for the phase III randomized study, which is being sponsored by the NCI’s newly established Office of Cancer Complementary and Alternative Medicine. Half the patients will receive standard therapy with gemcitabine (Gemzar), while the other half will take the Gonzalez regimen. With this rigorous diet, patients eat large amounts of raw fruits, raw and steamed vegetables, juices, cereals, and nuts, including up to 20 almonds a day. Fish is allowed in limited quantities. The diet excludes red meat, chicken, refined grain products, white sugar, and soy.

Patients also take approximately 150 pills a day, at regular intervals throughout the day, on an empty stomach. The pills include vitamins, minerals, amino acids, trace elements, glandular extracts, and 25 g to 40 g (40 pills) of freeze-dried pancreatic enzymes derived from pigs. Most patients take the pills for 15 days, stop for 5, and begin again.

During the 5-day break, patients undergo a “detoxification” process: They can use coffee enemas or drink fruit juices or a Metamucil-like product in conjunction with various herbs to “flush” their systems. The cost of the regimen is approximately $6,000 a year, but will be free to participants.

The trial, which was given a 5-year, $250,000 grant, is applying scientific methods to assess the efficacy of this alternative treatment. The NCI agreed to test the regimen after Nicholas Gonzalez, MD, a New York endocrinologist, conducted a pilot study of his protocol from 1993 to 1996.

The results, reported earlier this year in Nutrition and Cancer, showed that 9 of 11 pancreatic patients survived for 1 year, five survived for 2 years, and four survived for 3 years. These results surpassed those usually achieved with standard treatment for advanced disease.

The Gonzalez protocol derives from the work of John Beard, a turn-of-the-century Scottish embryologist who noted that placentas, which invade the uterus much as a tumor does, stop growing the day that the fetal pancreas begins to function. Thus, Beard theorized that pancreatic enzymes might also halt the growth of malignant tumors.

For information about patient entry into the trial, contact Michelle Gabay, RN [212-305-9468] at Columbia-Presbyterian Cancer Center.