NEW YORKAn 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
The researchers are seeking 72 to 90 patients with advanced
pancreatic cancer for the phase III randomized study, which is being
sponsored by the NCIs 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
For information about patient entry into the trial, contact Michelle
Gabay, RN [212-305-9468] at Columbia-Presbyterian Cancer Center.