The anticancer efficacy of the Gonzalez regimen has been investigated in two human studies (CPMC-IRB-8544 ¹ [1]), both involving patients with pancreatic cancer.

The first study, a prospective nonconsecutive case series conducted by the developer and an associate, included 11 patients diagnosed with adenocarcinoma of the pancreas (stage II or stage IV). None of the patients had received chemotherapy or radiation therapy, and none had undergone surgical resection with curative intent. All the patients had pancreatic tumors that were either unresected or partially resected. Survival from the time of diagnosis was the only study endpoint, and all 11 patients (including one who left the study) were included in this survival analysis.

The investigators reported a median survival time of 17 months and a mean survival time of 25.2 months for these patients. Nine patients (82%) survived 1 year, five patients (45%) survived 2 years, and four patients (36%) survived 3 years. At the time the study was reported, two patients were alive: one who had survived 3 years, and one had survived 4 years. The researchers concluded that the 1-year and 2-year survival percentages for this group of patients were superior to those observed for other U.S. patients diagnosed with adenocarcinoma of the pancreas (1-year survival, all stages = 25%; 2-year survival, all stages = 10%).[1]

The small number of patients in this study and the absence of a control group are limitations that raise doubts about the reliability of its findings. It is possible that important, unidentified differences between these patients and other patients diagnosed with stage II to stage IV pancreatic cancer contributed to the relatively long survival. The investigators report that 25 additional patients with pancreatic cancer were seen during the study period but were excluded from study participation. Eleven of these patients were excluded on the basis of comorbidities, previous treatment, or delay between diagnosis and beginning the program; 14 otherwise eligible patients were excluded on the grounds that they chose not to start the program, complied only briefly, or predicted noncompliance.[1]

The second study is a nonrandomized prospective case-control observational study (CPMC-IRB-8544 ¹) sponsored by the National Center for Complementary and Alternative Medicine and the National Cancer Institute in which median survival and quality of life were found to be better in patients treated with gemcitabine -based (i.e., other drugs may be included) chemotherapy than for patients treated with the Gonzalez regimen. This study was originally planned for randomization but changed after few patients elected to participate in the randomized trial. The same eligibility criteria were used to select patients for both treatment arms. The results of this study were reported in the peer-reviewed Journal of Clinical Oncology.[2] According to the report, 70 patients were evaluated for the study and 55 were enrolled: 23 in the gemcitabine arm and 32 in the enzyme treatment arm. The enzyme treatment included orally ingested proteolytic enzymes, nutritional supplements, detoxification, and an organic diet (as used in the pilot study by Gonzalez and Isaacs).[1] Patients received three pancreatic enzyme capsules and two magnesium citrate capsules with each meal. The patients also took specified numbers of capsules with magnesium citrate and Papaya Plus every 4 hours on an empty stomach. The dose for patients with stage II disease was 69 enzyme capsules per day, and the dose for patients with stages III or stage IV was 81 capsules per day. After day 16, patients had a 5-day rest period and then resumed treatment on day 22. Patients in the experimental arm received proteolytic treatment under the care of a practitioner familiar with the regimen; those in the chemotherapy arm received treatment by the oncologist they selected.[2] Treatment could be adjusted by the physician, and it could be increased for cancer progression. The gemcitabine treatment patients received various gemcitabine-containing regimens, with 19 of the 23 patients receiving a combination of gemcitabine, capecitabine, and docetaxel. The two groups had similar clinical characteristics. The median survival for the patients in the gemcitabine arm was 14 months and, on the enzyme arm, 4.3 months. The quality of life as measured by the FACT-PA was also better in the chemotherapy arm. The paper does not list Dr. Gonzalez as an author, and does not identify him as participating in the study; however, Dr. Gonzalez published comments on his Web site indicating his participation in the study and detailing his objections to how the study was designed and conducted.[3]

No data concerning the effectiveness of the Gonzalez regimen for the treatment of cancer patients with other types of cancer have been reported, despite claims that a variety of cancers can be treated. In addition, there is no safety or efficacy information on the regimen in children. No clinical trials of this regimen have been conducted in children, and this extremely difficult regimen may be prohibitive in young children.

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. Chabot JA, Tsai WY, Fine RL, et al.: Pancreatic Proteolytic Enzyme Therapy Compared With Gemcitabine-Based Chemotherapy for the Treatment of Pancreatic Cancer. J Clin Oncol : , 2009.  [PUBMED Abstract]
   
   
3. Gonzalez Nicholas: Journal of Clinical Oncology Article Rebuttal. New York, NY, 2009 Available online. ² Last accessed September 23, 2009. 
   
   

Glossary Terms

Cancer that begins in cells that line certain internal organs and that have gland-like (secretory) properties.

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 and can invade nearby tissues. Cancer cells can also spread to other parts of the body through the blood and lymph systems. There are several main types of cancer. Carcinoma is a cancer that begins in the skin or in tissues that line or cover internal organs. Sarcoma is a cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue. Leukemia is a 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. Also called malignancy.

A drug used to treat stage III colon cancer in patients who had surgery to remove the cancer. It is also used to treat metastatic breast cancer that has not improved after treatment with certain other anticancer drugs. Capecitabine is being studied in the treatment of other types of cancer. It is taken up by cancer cells and breaks down into 5-fluorouracil, a substance that kills tumor cells. Capecitabine is a type of antimetabolite. Also called Xeloda.

In medicine, a sac of tissue and blood vessels that surrounds an organ, joint, or tumor. A capsule is also a form for medicine that is taken by mouth. It usually has a shell made of gelatin with the medicine inside.

Treatment with drugs that kill cancer cells.

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.

To make something less poisonous or harmful. It may refer to the process of removing toxins, poisons, or other harmful substances from the body.

The process of identifying a disease, such as cancer, from its signs and symptoms.

The things a person eats and drinks.

A drug used together with other drugs to treat certain types of breast cancer, stomach cancer, prostate cancer, and certain types of head and neck cancer. It is also being studied in the treatment of other types of cancer. Docetaxel is a type of mitotic inhibitor. Also called Taxotere.

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

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.

Effectiveness. In medicine, the ability of an intervention (for example, a drug or surgery) to produce the desired beneficial effect.

In clinical trials, requirements that must be met for an individual to be included in a study. These requirements help make sure that patients in a trial are similar to each other in terms of specific factors such as age, type and stage of cancer, general health, and previous treatment. When all participants meet the same eligibility criteria, it gives researchers greater confidence that results of the study are caused by the intervention being tested and not by other factors.

In clinical trials, an event or outcome that can be measured objectively to determine whether the intervention being studied is beneficial. The endpoints of a clinical trial are usually included in the study objectives. Some examples of endpoints are survival, improvements in quality of life, relief of symptoms, and disappearance of the tumor.

A protein that speeds up chemical reactions in the body.

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 experimental in other diseases or conditions. Also called investigational.

The active ingredient in a drug that is used to treat pancreatic cancer that is advanced or has spread. It is also used together with other drugs to treat breast cancer that has spread, advanced ovarian cancer, and non-small cell lung cancer that is advanced or has spread. It is also being studied in the treatment of other types of cancer. Gemcitabine blocks the cell from making DNA and may kill cancer cells. It is a type of antimetabolite

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.

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.

The average time that patients in a clinical study remained alive. The time is measured beginning either at diagnosis or the start of treatment. Also called mean survival.

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. Also called median overall survival and median survival.

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.

A clinical study that includes some, but not all, of the eligible patients identified by the researchers during the study registration period. This type of study does not usually have a control group.

A product that is added to the diet. A nutritional supplement is taken by mouth, and usually contains one or more dietary ingredient (such as vitamin, mineral, herb, amino acid, and enzyme). Also called dietary supplement.

Closely monitoring a patient's condition but withholding treatment until symptoms appear or change. Also called active surveillance, expectant management, and watchful waiting.

A doctor who specializes in treating cancer. Some oncologists specialize in a particular type of cancer treatment. For example, a radiation oncologist specializes in treating cancer with radiation.

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.

Having to do with the pancreas.

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

Medical doctor.

The initial study examining a new method or treatment.

A person who works in a specific profession. For example, a doctor or nurse is a healthcare practitioner.

In medicine, the course of a disease, such as cancer, as it becomes worse or spreads in the body.

In medicine, a study or clinical trial in which participants are identified and then followed forward in time.

The overall enjoyment of life. Many clinical trials assess the effects of cancer and its treatment on the quality of life. These studies measure aspects of an individual’s sense of well-being and ability to carry out various activities.

The use of high-energy radiation from x-rays, gamma rays, neutrons, protons, and other sources to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external-beam radiation therapy), or it may come from radioactive material placed in the body near cancer cells (internal radiation therapy). Systemic radiation therapy uses a radioactive substance, such as a radiolabeled monoclonal antibody, that travels in the blood to tissues throughout the body. Also called irradiation and radiotherapy.

When referring to an experiment or clinical trial, the process by which animal or human subjects are assigned by chance to separate groups that compare different treatments or other interventions. Randomization gives each participant an equal chance of being assigned to any of the groups.

A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.

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

Removed by surgery.

Surgery to remove tissue or part or all of an organ.

Stage II is divided into stages IIA and IIB, based on where the cancer has spread. In stage IIA, cancer has spread to nearby tissue and organs but has not spread to nearby lymph nodes. In stage IIB, cancer has spread to nearby lymph nodes and may have spread to nearby tissue and organs.

Cancer may be of any size and has spread to distant organs, such as the liver, lung, and peritoneal cavity (the body cavity that contains most of the organs in the abdomen), and may have also spread to organs and tissues near the pancreas or to lymph nodes.

An organ that is part of the digestive system. The stomach helps digest food by mixing it with digestive juices and churning it into a thin liquid.

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 cancer), or malignant (cancer). Also called neoplasm.

Describes an organ, tissue, or cancer that has not been either partly or completely removed by surgery.