Dr. Gonzales said the pilot study and resulting clinical trial offers some hope for patients with pancreatic cancer, which has a one-year relative survival rate of only 19 percent and a five-year rate of only 4 percent.

"We desperately need better treatment for pancreatic cancer, of which the majority of patients die and die quickly because we do not have any good therapy for it," said Barrie Cassileth, PhD, chief of integrative medicine, Memorial Sloan-Kettering Cancer Center. "It would be very exciting if this approach turns out to be beneficial, though many oncologists are skeptical and believe that even though the case results look promising, the end result will not support the validity of the trials. That’s exactly why trials are necessary."

The purpose of pilot studies, which involve a very small number of patients, is to find out if a treatment has any significant effect on the cancer. If some evidence is seen, the treatment moves into the next phase of testing. Pilot studies do not provide definitive proof of effectiveness.

As of January 12, 1999, nine of 11 patients in the pilot study had survived one year; five had survived two years; and four had survived four years. One of Dr. Gonzales’ patients, who has been following the regimen (which includes 150 supplements per day) since 1991, is 75 years old and in excellent health, showing no evidence of disease.

Changes in Diet

As detailed in the journal Nutrition and Cancer (Vol. 33, No. 2), Dr. Gonzales promotes a diet emphasizing fresh raw fruits, raw and lightly steamed vegetables, and fresh vegetable juice daily. The diet encourages plant-based protein sources such as cereals, nuts and seeds, and whole-grain products such as bread and brown rice. It allows one or two eggs daily, whole milk yogurt daily, and fish two or three times a week. The diet forbids all red meat and poultry.

The supplements include vitamins, minerals, and trace elements as a supportive, not an anticancer, regimen. Dr. Gonzales also prescribes certain freeze-dried organ concentrates such as thymus and liver. Each patient takes a capsule of porcine (pig) lyophilized (freeze-dried) pancreas product daily.
 
The detoxification procedures include twice-daily coffee enemas, believed by alternative medicine practitioners to enhance liver function and the processing and excretion of metabolic wastes, Dr. Gonzales said.
 
Seeking Participants
Columbia Presbyterian Medical Center in New York is seeking participants for the five-year clinical trial sponsored by the NCI. Interested persons may contact John Chabot, MD, chief of surgical oncology at Columbia Presbyterian at 212-305-9468.

The clinical trial was originally set up as a randomized study, but an initial flood of interested patients revealed they wanted to be in the trial only if they could get the alternative treatment. As a result, NCI changed the trial to a non-randomized study so patients may choose between chemotherapy and the alternative therapy.

If the trial is successful, Dr. Gonzales said, it would mean that this regimen could become an accepted therapy like radiation or chemotherapy.

"I applaud Dr. Gonzales for his willingness and courage to participate in this kind of study where he’s willing to turn over [his treatment] for review to a major comprehensive cancer center and take the results, whatever they might be," Dr. Cassileth said.