Directly relevant laboratory or animal data concerning the anticancer potential of the Gonzalez regimen are limited. Published animal studies focus on the role of pancreatic enzymes in cancer treatment rather than the regimen as a whole.

An animal study published in 1999 measured the ability of orally administered porcine pancreas preparation (PPP) to slow or halt the growth of cancer and to inhibit metastasis. Sixty Fischer F344 female rats were divided into five groups of 12 each. All groups were fed the same basic diet. After 5 days, R13762 transplantable rat mammary tumor was implanted into a mammary fat pad on each rat. The animals were maintained on their assigned diets for another 40 days. After the tumors had taken hold, two groups were given a high dose of PPP (20% by weight) and two groups were given a lower dose (2% by weight). The fifth group was used as a control and received no enzymes. In addition, one group from each of the PPP-dosed rat groups was also given a magnesium citrate supplement because magnesium is often given with PPP in clinical practice.[1]

Results showed that PPP had no effect on tumor growth, and PPP alone did not show any significant effect on the amount of metastases. However, when the rate of metastases in the rats dosed at the 20% rate was compared with those dosed at 2%, it was noted that there was an increase in metastases in the rats given a higher dose of PPP. The lowest rate of metastases was seen in the rats given the 2% dose plus magnesium citrate.[1]

In another study, the effects of porcine pancreatic enzyme (PPE) extracts on survival and tumor growth were examined in 5- to 6-week-old male beige X-linked immunodeficient mice. In the survival study, two groups of mice received pancreatic cancer cells AsPc1 injected into their pancreas. The treatment group (14 mice) received PPE in water at a dose of 400 mg/kg of body weight, which corresponds to the dose used in patients receiving the Gonzalez regimen. The control group (13 mice) was given only water. After death, the pancreas was removed and measured for volume and weight. The median survival rates for the treatment group and the control group were 43.5 days and 35 days, respectively. At day 35, the survival rates were 79% in the treatment group and 38% in the control group. In addition, the control mice showed reduced activity as compared with the treatment group, which showed normal activity and no signs of disease. In general, the size of tumors and the rate of invasion in the liver and peritoneum correlated with length of survival time.[2]

In the tumor growth segment of this study, a second group of 30 mice was taken through the same procedures. Tumor size and weight were measured in two mice from each group on day 52, and again in two mice from the control group and five mice from the treatment group on day 60. Ascites were much more apparent in the control group than in the treatment group. Physical activity among the treated mice was much greater than in the control group. Results showed that the treatment group had significantly smaller tumors than the control group in both weight and volume. The mean tumor weight was 1.2 g in the control group and 0.75 g in the treatment group. The tumor volume was 0.42 cm³ in the treatment group and 0.91 cm³ in the control group. All mice in the control group showed steatorrhea, hyperglycosuria, hyperbilirubinuria, and ketonuria in the early stages of tumor growth, whereas in the treated group only a few mice showed these abnormalities in the final stages. There were no differences in the tumors of the treatment and control groups in the expression of growth factors, epidermal growth factor receptor, or apoptotic rate.[2]

References

1. Cohen LA, Aliaga C, Pittman B, et al.: Oral enzyme therapy and experimental rat mammary tumor metastasis. Life Sci 65 (24): 2603-14, 1999.  [PUBMED Abstract]
   
   
2. Saruc M, Standop S, Standop J, et al.: Pancreatic enzyme extract improves survival in murine pancreatic cancer. Pancreas 28 (4): 401-12, 2004.  [PUBMED Abstract]
   
   

Glossary Terms

Abnormal buildup of fluid in the abdomen that may cause swelling. In late-stage cancer, tumor cells may be found in the fluid in the abdomen. Ascites also occurs in patients with liver disease.

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.

In a clinical trial, the group that does not receive the new treatment being studied. This group is compared to the group that receives the new treatment, to see if the new treatment works.

The things a person eats and drinks.

The amount of medicine taken, or radiation given, at one time.

The protein found on the surface of some cells and to which epidermal growth factor binds, causing the cells to divide. It is found at abnormally high levels on the surface of many types of cancer cells, so these cells may divide excessively in the presence of epidermal growth factor. Also called EGFR, ErbB1, and HER1.

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

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.

A substance made by the body that functions to regulate cell division and cell survival. Some growth factors are also produced in the laboratory and used in biological therapy.

A substance or object that is put in the body as a prosthesis, or for treatment or diagnosis.

Use of a syringe and needle to push fluids or drugs into the body; often called a "shot."

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

In medicine, a mineral used by the body to help maintain muscles, nerves, and bones. It is also used in energy metabolism and protein synthesis.

Having to do with the breast.

A statistics term. The average value in a set of measurements. The mean is the sum of a set of numbers divided by how many numbers are in the set.

The time from either diagnosis or treatment at which half of the patients with a given disease are found to be, or expected to be, still alive. In a clinical trial, median survival time is one way to measure how effective a treatment is.

The spread of cancer from one part of the body to another. A tumor formed by cells that have spread is called a “metastatic tumor” or a “metastasis.” The metastatic tumor contains cells that are like those in the original (primary) tumor. The plural form of metastasis is metastases (meh-TAS-tuh-SEEZ).

By or having to do with the mouth.

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 disease in which malignant (cancer) cells are found in the tissues of the pancreas. Also called exocrine cancer.

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

The tissue that lines the abdominal wall and covers most of the organs in the abdomen.

Having to do with or coming from pigs.

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

In statistics, describes a mathematical measure of difference between groups. The difference is said to be significant if it is greater than what might be expected to happen by chance alone. Also called statistically significant.

The extent of a cancer in the body. Staging is usually based on the size of the tumor, whether lymph nodes contain cancer, and whether the cancer has spread from the original site to other parts of the body.

Adding nutrients to the diet.

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.