Source: National Cancer Institute Research, www.cancer.gov
NOTE: The information in this summary is no longer being updated and is provided for reference purposes only.
The Gonzalez regimen is a complex treatment plan based on the role of enzymes, vitamins, minerals, and other dietary factors. The developer of the regimen, Dr. Nicholas Gonzalez, promotes it as a treatment for advancedpancreatic cancer. Supporters of the Gonzalez regimen say it fights cancer in these ways:
Some key parts of the regimen include the following:
In 1902, James Beard, a Scottish physician, suggested that pancreatic enzymes might control and kill cancer cells. Later, William Kelley, a dentist, further developed Dr. Beard’s ideas and published the results of his own practice. Impressed by these findings, Dr. Gonzalez began working closely with Dr. Kelley. The Gonzalez regimen combines the work of Dr. Gonzalez and Dr. Kelley with the theories and practice of Dr. Max Gerson. Dr. Gerson also treated cancer with diet and nutritional supplements.
Supporters of the Gonzalez regimen believe that toxins (harmful substances) in the environment and in processed foods cause cancer to form in the body. These toxins are said to build up in tissues of the body, preventing important body processes from working correctly and letting cancer develop. The theory is that if these toxins could be destroyed and removed from the body, cancer would stop growing.
The pancreas secretes enzymes, proteins that help digest food. The Gonzalez regimen is based on the theory that pancreatic enzymes also help the body get rid of toxins that lead to cancer. The coffee enemas are added because they are believed to improve the liver’s ability to remove toxins from the body.
The diets used in the Gonzalez regimen are planned for each patient’s metabolic type. Metabolic typing is a theory that people fall into one of three groups based on the main type of food (protein, carb, or mixed) that their bodies need to stay healthy. The developer uses certain tests, including looking at the patient’s hair under a microscope, to decide a patient’s metabolic type. The theory is that a diet that is correct for the patient’s metabolic type will keep the body healthy and better able to prevent or fight cancer.
The pancreatic enzyme is taken by mouth, in a capsule. Between 130 and 160 doses of other nutritional supplements are taken by mouth each day. The patients also eat a special diet and have coffee enemas twice a day.
Research in a laboratory or using animals is done to find out if a drug, procedure, or treatment is likely to be useful in humans. These preclinical studies are done before any testing in humans is begun. Animal studies of the Gonzalez regimen looked at the effect of pancreatic enzymes in cancer treatment, but did not study the regimen as a whole. There has been preclinical testing on the effects of pancreatic enzymes in several cancers:
Nicholas Gonzalez, a New York physician, first studied his regimen in 11 patients who had advanced pancreatic cancer. In 1993, he reported selected results of the study to the National Cancer Institute (NCI). Patients treated with the Gonzalez regimen lived a median of 17 months, which is longer than usual for patients with this disease. Most patients with advanced pancreatic cancer live less than a year.
Because of the small number of patients in the study, and for other reasons, the NCI and the Office of Alternative Medicine (OAM) decided that the results were not clear and prospective studies were encouraged. In prospective studies, patients are followed forward in time. The NCI and the National Center for Complementary and Alternative Medicine (NCCAM) sponsored a second study with a much larger number of patients. This was a 7-year clinical study that included patients who had stage II, stage III, or stage IV pancreatic cancer that could not be removed by surgery.
In this study, one group of patients followed the Gonzalez regimen while another group was given standard treatment (chemotherapy). Results in the two groups were compared to see if the Gonzalez regimen works better than the standard treatment and if it has bad side effects. Results of the study were reported in the peer-reviewedJournal of Clinical Oncology in April 2010. Patients treated with standard chemotherapy survived a median of 14 months and patients treated with the Gonzalez regimen survived a median of 4.3 months. Patients treated with chemotherapy reported a better quality of life than those treated with the Gonzalez regimen. Dr. Gonzalez published comments on his Web site to express concerns about how the trial was conducted. One concern was how well patients in the Gonzalez regimen group actually followed the regimen.
The reported side effects of treatment with the Gonzalez regimen are the following:
There is no information on the side effects of the coffee enemas taken twice a day. Taking too many enemas of any kind can cause changes in normal blood chemistry, chemicals that occur naturally in the body and keep the muscles, heart, and other organs working properly.
The FDA has not approved the Gonzalez regimen or any of its components as a cancer treatment.
Complementary and alternative medicine (CAM)—also referred to as integrative medicine—includes a broad range of healing philosophies, approaches, and therapies. A therapy is generally called complementary when it is used in addition to conventional treatments; it is often called alternative when it is used instead of conventional treatment. (Conventional treatments are those that are widely accepted and practiced by the mainstream medical community.) Depending on how they are used, some therapies can be considered either complementary or alternative. Complementary and alternative therapies are used in an effort to prevent illness, reduce stress, prevent or reduce side effects and symptoms, or control or cure disease.
Unlike conventional treatments for cancer, complementary and alternative therapies are often not covered by insurance companies. Patients should check with their insurance provider to find out about coverage for complementary and alternative therapies.
Cancer patients considering complementary and alternative therapies should discuss this decision with their doctor, nurse, or pharmacist as they would any therapeutic approach, because some complementary and alternative therapies may interfere with their standard treatment or may be harmful when used with conventional treatment.
It is important that the same rigorous scientific evaluation used to assess conventional approaches be used to evaluate CAM therapies. The National Cancer Institute (NCI) and the National Center for Complementary and Alternative Medicine (NCCAM) are sponsoring a number of clinical trials (research studies) at medical centers to evaluate CAM therapies for cancer.
Conventional approaches to cancer treatment have generally been studied for safety and effectiveness through a rigorous scientific process that includes clinical trials with large numbers of patients. Less is known about the safety and effectiveness of complementary and alternative methods. Few CAM therapies have undergone rigorous evaluation. A small number of CAM therapies originally considered to be purely alternative approaches are finding a place in cancer treatment—not as cures, but as complementary therapies that may help patients feel better and recover faster. One example is acupuncture. According to a panel of experts at a National Institutes of Health (NIH) Consensus Conference in November 1997, acupuncture has been found to be effective in the management of chemotherapy-associated nausea and vomiting and in controlling pain associated with surgery. In contrast, some approaches, such as the use of laetrile, have been studied and found ineffective or potentially harmful.
The NCI Best Case Series Program, which was started in 1991, is one way CAM approaches that are being used in practice are being investigated. The program is overseen by the NCI’s Office of Cancer Complementary and Alternative Medicine (OCCAM). Health care professionals who offer alternative cancer therapies submit their patients’ medical records and related materials to OCCAM. OCCAM conducts a critical review of the materials and develops follow-up research strategies for approaches deemed to warrant NCI-initiated research.
When considering complementary and alternative therapies, patients should ask their health care provider the following questions:
The National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health (NIH) facilitates research and evaluation of complementary and alternative practices, and provides information about a variety of approaches to health professionals and the public.
NCCAM and the NIH National Library of Medicine (NLM) jointly developed CAM on PubMed, a free and easy-to-use search tool for finding CAM-related journal citations. As a subset of the NLM's PubMed bibliographic database, CAM on PubMed features more than 230,000 references and abstracts for CAM-related articles from scientific journals. This database also provides links to the Web sites of over 1,800 journals, allowing users to view full-text articles. (A subscription or other fee may be required to access full-text articles.) CAM on PubMed is available through the NCCAM Web site. It can also be accessed through NLM PubMed bibliographic database by selecting the "Limits" tab and choosing "Complementary Medicine" as a subset.
The NCI Office of Cancer Complementary and Alternative Medicine (OCCAM) coordinates the activities of the NCI in the area of complementary and alternative medicine (CAM). OCCAM supports CAM cancer research and provides information about cancer-related CAM to health providers and the general public via the NCI Web site.
U.S. residents may call the NCI Cancer Information Service toll free at 1-800-4-CANCER (1-800-422-6237) Monday through Friday from 8:00 am to 8:00 pm. A trained Cancer Information Specialist is available to answer your questions.
The Food and Drug Administration (FDA) regulates drugs and medical devices to ensure that they are safe and effective.
The Federal Trade Commission (FTC) enforces consumer protection laws. Publications available from the FTC include: