The Gonzalez regimen combines prescribed diets, nutritional supplements, coffee enemas, and pancreatic enzymes in a cancer management program. The regimen is intended to detoxify the body, correct nervous system imbalances that might lead to impaired general health, and support natural immune processes. The pancreatic enzymes are thought to be the specific anticancer component of the Gonzalez program.[1-4]

Two major concepts underlie use of the Gonzalez regimen in cancer treatment. The first concept is that the pancreas, like the liver, is an organ that performs a detoxification function and that pancreatic enzymes help the body eliminate toxins and help normal cells repair damaged cells.[2] The second concept is that cancer and most other human illness are related to physiological imbalances created by environmental toxins either consumed in food or contacted in the environment.[2,4]

Proponents of the Gonzalez regimen believe that toxins from sources such as processed foods and environmental pollution are responsible for human cancers. These toxins are thought to accumulate in tissues and over time create imbalances in the autonomic nervous system, diminish the normal immune response, and give rise to cellular damage that can lead to cancer.[2,4] If these toxins could be neutralized and eliminated from the body, proponents believe, both early and established cancers would be halted, and general health would be restored.[2,4]

According to the developer of the Gonzalez regimen, the diets used in this regimen are chosen for each patient according to individual metabolic profiles established at the time of initial evaluation through various tests, including hair analysis. There are ten basic diets and 90 variations.[2] The diets emphasize organic foods. Each diet carries a particular focus and can range from strictly vegetarian diets to diets high in meat and fat. Variations in the diets correlate with the theory that imbalances in the autonomic nervous system are exacerbated by a diet that is inappropriate for the patient’s metabolic type.[2,4]

Nutritional supplements employed in the Gonzalez regimen include vitamins, minerals, trace elements, amino acids, and extracts of animal organs (e.g., thymus and liver extracts from sheep or cows). As with the dietary protocols, the nutritional supplements are intended to correct autonomic nervous system imbalances.[2-4]

The major feature of the Gonzalez regimen is freeze-dried porcine pancreatic enzyme (PPE) administered in capsule form as part of the nutritional supplementation aspect of the program. Obtained from pigs, PPE is considered to be the primary cancer-fighting component in the regimen and to contribute to the overall detoxification process.[2]

Proponents of the regimen believe that the pancreatic enzymes are delivered to the bloodstream and help the body eliminate and destroy abnormal cells, waste material, and abnormal proteins that are toxic to the body. As the body detoxifies, the cancerous tumors tend to shrink.[2]

Coffee enemas are also included as part of the detoxification process. The enemas are administered twice daily.[4] The use of coffee enemas is based on a belief that coffee introduced into the lower intestinal tract will improve liver function and stimulate emptying of the gallbladder, thereby enhancing the elimination of toxins and waste products from the body.[2-4]

The Gonzalez regimen is available only to private patients of its New York-based practitioner [3] and to those participating in a clinical trial (CPMA-IRB-8544 ¹) sponsored by the National Center for Complementary and Alternative Medicine and the National Cancer Institute.

Pancreatic enzymes are sold in the United States as either prescription drugs indicated for pancreatic insufficiency [5] or over-the-counter (OTC) dietary supplements. As of 2004, those sold as prescription drugs must have a New Drug Approval from the US Food and Drug Administration (FDA) to be marketed legally in the United States. Pancreatic enzymes sold as OTC dietary supplements are regulated as foods, not drugs, and the FDA has no jurisdiction over the regulation of foods. Dietary supplements in the United States are therefore sold without any regulation by the FDA, as long as they do not claim to treat or prevent a specific disease or condition. According to the developer of the Gonzalez regimen, OTC preparations or other commercially available pancreatic enzymes are not effective against cancer.[4]

The PPE preparation used in the Gonzalez regimen is manufactured in New Zealand for use in the program.[3]

For the FDA, PPE falls under the category of a new prescription drug that is under investigation. To conduct clinical drug research in the United States, researchers must file an Investigational New Drug (IND) application with the FDA. To date, only one group of investigators is known to have IND approval to study this pancreatic enzyme preparation as a treatment for cancer. The IND process is confidential, and the existence of an IND can be disclosed only by the applicant(s).

References

1. Gonzalez NJ, Isaacs LL: Evaluation of pancreatic proteolytic enzyme treatment of adenocarcinoma of the pancreas, with nutrition and detoxification support. Nutr Cancer 33 (2): 117-24, 1999.  [PUBMED Abstract]
   
   
2. Gonzalez N: Dr. Nicholas Gonzalez on nutritional cancer therapy: a Moneychanger interview. The Moneychanger July 1995. Also available online ². Last accessed February 4, 2008. 
   
   
3. Gonzalez N, Kushi L: The dietary treatment of cancer (part II). In: Comprehensive Cancer Care: Integrating Complementary and Alternative Therapies - A Conference for Health professionals, June 12-14, 1998. Breakout Session 404. Available online ³. Last accessed May 2, 2006. 
   
   
4. Gonzalez NJ: Pancreatic cancer, proteolytic enzyme therapy and detoxification [excerpts]. Clinical Pearls News November 1999. Also available online ⁴. Last accessed February 4, 2008. 
   
   
5. Physician's Desk Reference 2005. 59th ed. Montvale, NJ: Thomson PDR, 2005. 
   
   

Glossary Terms

Not normal. An abnormal lesion or growth may be cancerous, premalignant (likely to become cancer), or benign.

One of several molecules that join together to form proteins. There are 20 common amino acids found in proteins.

A process in which anything complex is separated into simple or less complex parts.

A term for diseases in which abnormal cells divide without control. Cancer cells can invade nearby tissues and can spread to other parts of the body through the blood and lymph systems. There are several main types of cancer. Carcinoma is cancer that begins in the skin or in tissues that line or cover internal organs. Sarcoma is cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue. Leukemia is cancer that starts in blood-forming tissue such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the blood. Lymphoma and multiple myeloma are cancers that begin in the cells of the immune system. Central nervous system cancers are cancers that begin in the tissues of the brain and spinal cord.

The individual unit that makes up the tissues of the body. All living things are made up of one or more cells.

Having to do with the examination and treatment of patients.

A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical study.

The injection of coffee through the anus into the colon (large intestine). Coffee enemas are being tested in the treatment of pancreatic cancer.

The things a person eats and drinks.

Any substance, other than food, that is used to prevent, diagnose, treat or relieve symptoms of a disease or abnormal condition. Also refers to a substance that alters mood or body function, or that can be habit-forming or addictive, especially a narcotic.

In medicine, a preparation of a substance obtained from plants, animals, or bacteria and used as a drug or in drugs.

An agency in the U.S. federal government whose mission is to protect public health by making sure that food, cosmetics, and nutritional supplements are safe to use and truthfully labeled. The Food and Drug Administration also makes sure that drugs, medical devices, and equipment are safe and effective, and that blood for transfusions and transplant tissue are safe. Also called FDA.

A method used to dry substances, such as food, to make them last longer. The substance is frozen and then dried in a vacuum.

The pear-shaped organ found below the liver. Bile is concentrated and stored in the gallbladder.

An alternative therapy that is being studied as a treatment for pancreatic cancer. It includes a special diet, nutritional supplements, pancreatic enzymes, and coffee enemas.

The activity of the immune system against foreign substances (antigens).

The complex group of organs and cells that defends the body against infections and other diseases.

Having to do with the intestines.

In clinical trials, refers to a drug (including a new drug, dose, combination, or route of administration) or procedure that has undergone basic laboratory testing and received approval from the U.S. Food and Drug Administration (FDA) to be tested in human subjects. A drug or procedure may be approved by the FDA for use in one disease or condition, but be considered investigational in other diseases or conditions. Also called experimental.

A large organ located in the upper abdomen. The liver cleanses the blood and aids in digestion by secreting bile.

Having to do with metabolism (the total of all chemical changes that take place in a cell or an organism to produce energy and basic materials needed for important life processes).

A nutrient required to maintain health.

The National Cancer Institute, part of the National Institutes of Health of the United States Department of Health and Human Services, is the Federal Government's principal agency for cancer research. The National Cancer Institute conducts, coordinates, and funds cancer research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer. Access the National Cancer Institute Web site at http://www.cancer.gov. Also called NCI.

The taking in and use of food and other nourishing material by the body. Nutrition is a 3-part process. First, food or drink is consumed. Second, the body breaks down the food or drink into nutrients. Third, the nutrients travel through the bloodstream to different parts of the body where they are used as "fuel" and for many other purposes. To give the body proper nutrition, a person has to eat and drink enough of the foods that contain key nutrients.

A part of the body that performs a specific function. For example, the heart is an organ.

A medicine that can be bought without a prescription (doctor's order). Examples include analgesics (pain relievers) such as aspirin and acetaminophen. Also called nonprescription and OTC.

A glandular organ located in the abdomen. It makes pancreatic juices, which contain enzymes that aid in digestion, and it produces several hormones, including insulin. The pancreas is surrounded by the stomach, intestines, and other organs.

A protein secreted by the pancreas that aids in the digestion of food.

Having to do with the functions of the body. When used in the phrase "physiologic age," it refers to an age assigned by general health, as opposed to calendar age.

Having to do with or coming from pigs.

A doctor's order for medicine or another intervention.

A molecule made up of amino acids that are needed for the body to function properly. Proteins are the basis of body structures such as skin and hair and of substances such as enzymes, cytokines, and antibodies.

A treatment plan that specifies the dosage, the schedule, and the duration of treatment.

Adding nutrients to the diet.

An organ that is part of the lymphatic system, in which T lymphocytes grow and multiply. The thymus is in the chest behind the breastbone.

A group or layer of cells that work together to perform a specific function.

Having to do with poison or something harmful to the body. Toxic substances usually cause unwanted side effects.

A poison produced by certain animals, plants, or bacteria.

An element found in very small amounts in a given substance. Organisms need certain trace elements to survive.

An abnormal mass of tissue that results when cells divide more than they should or do not die when they should. Tumors may be benign (not cancerous), or malignant (cancerous). Also called neoplasm.

A key nutrient that the body needs in small amounts to grow and stay strong. Examples are vitamins A, C, and E.