The US National Cancer Institute, through its office of Complementary and Alternative Medicine, is funding phase III clinical trials of a controversial treatment for advanced pancreatic cancer.
The treatment protocol, the Gonzalez regimen, involves a programme of dietary modification, nutritional supplements, and “detoxification” through coffee enemas. Patients with stage II-IV pancreatic cancer are being enrolled.
The study was initially established in 1993, when Dr Nicholas Gonzalez submitted selected unpublished results of his cancer therapy to the National Cancer Institute. The initial cohort involved 11 patients with diverse cancers who were treated with his regimen.
Anecdotal evidence led Dr Gonzalez to concentrate his efforts on pancreatic cancer, which he thought was more responsive to nutritional therapy than other types of cancer.
Preliminary data showed that patients with pancreatic cancer who were treated by the Gonzalez regimen survived an average of 17.5 months more than those who received conventional chemotherapy.
On the basis of the results of this preliminary study, 90 patients with pancreatic cancer refractory to surgery were randomised to one of two arms: 45 patients received intravenous chemotherapy with the nucleoside inhibitor drug gemcitabine for 30 minutes once a week for seven weeks; the other 45 patients were enrolled in the nutritional arm, which involved ingesting up to 150 dietary supplements daily and taking coffee enemas. The supplements included animal glandular extracts, vitamins, trace minerals, papaya, and magnesium citrate. Pancreatic enzymes were also administered.
Both the study and its sponsors are controversial. Detractors point out that, although Dr Gonzalez is a physician, he has never gone beyond the basic medical degree in terms of residencies or board certification.
His protocol, moreover, is based on a theory promulgated by the Scottish anatomist John Beard in the early years of the last century and popularised by a dentist, William Kelley, in the 1980s. This theory holds that cancer is one disease emanating from ectopic germ cells, which are allowed to grow due to a deficiency of proteases.
According to this theory, supplemental treatment with pancreatic enzymes is required to digest the cancerous cells. Coffee enemas are given to “stimulate” the liver to detoxify the cancers and to reduce the incidence of the tumour lysis syndrome.
This theory flies in the face of the modern understanding of neoplasia, which sees cancer as multiple diseases with genetic and environmental bases.
Despite unproved theories, the alternative regimen has received attention and an aura of credibility. Pancreatic cancer is rarely curable, so any regimen that has shown a possibility of increasing survival is worth studying.
Moreover, the National Center for Complementary and Alternative Medicine is mandated to fund alternative and complementary treatments and subject them to the same rigorous review as conventional treatments. It has done this through funding wings in various universities.
The phase III trial is being conducted through a $1.4m (£930000) grant given to Columbia University's Rosenthal Center for Alternative Medicine in New York.