Since the death of my long-time colleague and friend, Nicholas Gonzalez, MD, I have continued to offer the same protocol that we used for patients with cancer and other degenerative diseases. The method is based on the work of William Donald Kelley, DDS; Nick had reviewed Kelley’s records and found many remarkable patient outcomes, as detailed in his book One Man Alone.¹ Nick and I co-authored an article with 30 case reports in Alternative Therapies in Health and Medicine in 2007.² At the time of his death, Nick was working on a collection of case reports from his practice and mine, which was subsequently published in two volumes.^3,4

In a 2019 article, I reported the outcomes of two patients I first saw around the time of Nick’s death in 2015.⁵ Below, I provide an update of their status.

Patient 1: Metastatic Colon Cancer

Patient 1 had a right colectomy in May 2014, for a 4.5 cm adenocarcinoma with metastases in 2/32 lymph nodes. CT scan July 2014 showed three hepatic hemangiomas.

Instead of the recommended chemotherapy, Patient 1 followed a self-designed nutritional plan. CT December 2014 showed the three hepatic hemangiomas seen previously, and a low-attenuation lesion described as unchanged from previous exams. PET scan was negative; but his CEA was steadily rising, so he began chemotherapy with FOLFOX. CT scan June 2015 showed, in addition to the three hemangiomas, a new 0.8 x 0.9 cm low attenuation lesion in the liver. He discontinued chemotherapy at that time.

By December 2015, the liver lesion had grown to 1.7 x 1.5 cm. In February 2016, he underwent partial resection of the right lobe of the liver. The pathology report stated: “Metastatic adenocarcinoma, consistent with colonic primary, extending focally to margin of resection.”

He began a nutritional program under my direction in April 2016. Around the same time, a scan showed “Enlarging low attenuation lesion within the right lobe of the liver suspicious for metastatic disease.”

After two months on his protocol, abdominal CT showed a low attenuation hepatic mass, and CT of the chest showed a new “slight lobulated nodule … measuring 0.9 x 0.8 cm.” His oncologist strongly recommended resection of the lung nodule and the liver mass, as well as resumption of chemotherapy. However, Patient 1 told me that FOLFOX made him so sick that he would rather be dead.

In mid-July 2016, he underwent resection of the right lobe of the liver which contained a 1.5 x 4.0 x 2.7 cm well-circumscribed lesion. Microscopic examination showed “Metastatic nodule of colorectal-type adenocarcinoma with no residual viable tumor identified.” The finding of necrotic tissue, rather than viable cancer, is interesting since he had not received chemotherapy for more than a year.

He refused resection of the lung mass and continued on the protocol I prescribed, with no other treatment. A series of CTs have shown no further activity in the liver, and gradual shrinkage and disappearance of the lung mass. In March 2021, he told me that his oncologist marvels at the resolution of his Stage IV disease. Patient 1 has never told his oncologist about his nutritional program.

In summary, a liver metastasis developed in this patient while he was receiving FOLFOX chemotherapy. It was resected, and he began treatment with me roughly 10 weeks after surgery. Ten weeks later, scans demonstrated a recurrent liver lesion and a new lung lesion. The liver lesion was removed, and pathology showed “no residual viable tumor”; he had received no orthodox treatment of any kind during this window. Since then, the patient has had gradual resolution of the lung lesion, with no evidence for disease in several scans, while pursuing only the prescribed nutritional protocol.

In a review and meta-analysis of palliative chemotherapy for colon cancer, median survival was estimated to be 8.0 months for untreated patients and 11.7 months for the chemotherapy group.⁶ Patient 1 is now more than five years out from the discovery of metastatic disease.

Patient 2: Metastatic Non-Small Cell Lung Cancer

Patient 2: Metastatic Adenocarcinoma

In October 2013, Patient 2 reported vision changes, vertigo, and headaches to his local doctor. Scans showed masses in his lung and brain, and in February 2014, the brain mass was resected. Pathology demonstrated “metastatic adenocarcinoma, most consistent with a non-small cell lung primary.”

March 2014 PET/CT revealed a 7 mm pulmonary nodule with intense uptake, and focal activity in the hilum. MRI of the head showed enhancement along the resection cavity. He then underwent radiation to the brain.

He was told he would most likely be dead in six months regardless of treatment, so he refused chemotherapy and began a self-designed nutritional plan. On this, his disease progressed. Chest CT August 2014 showed the lung lesion was larger at 1.5 cm, the hilar node also larger at 2.5 cm, and several new small nodules were seen, felt to be metastases. MRI of the brain September 2014 showed a new 1 cm tumor in the frontal lobe; in a repeat scan in December, the frontal lobe mass measured 1.7 cm, and a new mass had developed in the cerebellum.

I first saw Patient 2 in late December 2014. At that time, he felt well, though he did report visual changes caused by his original brain surgery. He had no symptoms from his pulmonary disease.

In January 2015, he started the protocol I prescribed, but he also proceeded with glucocorticoids followed by radiation to both tumors in his brain, because of concerns about impending herniation. After completing radiation, he developed excruciating headaches, and was found to have extensive vasogenic edema with midline shift. In June 2015, he called to let me know that despite all these issues, he had stayed on the prescribed nutritional program. Chest CT August 2015 showed that the previously seen masses had resolved. MRI of the brain September 2015 was unchanged from a June study. In March 2016, he let me know that a recent MRI of the brain demonstrated a slight decrease of enhancement in the resection bed, to the amazement of his neurologist.

During 2017 and 2018, he continued in his usual state of health, with visual problems felt due to his brain surgery and radiation. MRI of the brain April 2018, compared to a June 2016 scan, was read as “persistent right cerebral masses, slightly enlarged.” Then in late June 2018, he called me to report episodes of left-sided weakness and shaking. I told him to go the emergency room.

In the hospital, chest CT July 2018 showed “No evidence of metastatic disease or primary neoplasm involving the thorax.” An MRI of the brain, compared with the April 2018 study, showed “Interval increase in size of right frontal mass with signs of recent hemorrhage … with increased surrounding vasogenic edema … stable right parietotemporal mass with surrounding vasogenic edema.” His physicians concluded that the brain masses represented post-radiation changes, with the acute clinical change due to hemorrhage, and he was discharged on a glucocorticoid taper and levetiracetam.

I told him at the time that despite the clear chest CT, he should not assume that his cancer was gone, and should not stop his nutritional protocol. Unfortunately, because of his poor vision, and left-sided weakness from the June 2018 hemorrhage, he was never able to resume it. He lived alone, with very little social support, and was having great difficulty managing daily activities such as shopping, cooking, and cleaning. He contacted me occasionally to update me about his situation, and then again to let me know that his disease had recurred with a vengeance. He passed away in May 2020.

In summary, this patient with non-small cell lung cancer had one brain metastasis removed, then radiation to recurrent brain lesions, but had no systemic treatment and no treatment of any kind to the lung lesion or the hilar nodes. While he was able to continue his nutritional program, there was no evidence of disease in the thorax; but after his neurological deterioration due to hemorrhage, he could no longer follow it; his disease recurred, and he expired.

In a review of cases of non-small cell lung cancer metastatic to the brain, median survival was about 10 months.⁷ Patient 2’s six-year survival is remarkable, as is the resolution of the lung tumor without orthodox therapy of any kind during the period he was able to follow his nutritional protocol. And while I am saddened by his death, in our last conversation he told me he was grateful for the extra time he had, and he promised he would put in a good word with St. Peter for me.

Discussion

The treatment protocol used with these patients involves three components: large doses of a pancreas product naturally rich in enzymes; diet and nutritional supplementation designed to address autonomic nervous system imbalance; and detoxification with several modalities, including coffee enemas. All three aspects are necessary for success.

Pancreas product. The theoretical mechanisms behind the use of pancreatic enzymes against cancer have been reviewed in detail elsewhere.^8,9 To summarize, more than a century ago, the British embryologist John Beard noted the similarity between cancer and the trophoblast, the early stage of the placenta.¹⁰ Both tissues are undifferentiated, invasive, and able to create a blood supply. But at a certain point in gestation, the trophoblast modifies its aggressive behavior and transforms into the mature placenta. Beard observed that this transformation occurred at the same time the fetal pancreas began to synthesize enzymes, and speculated that pancreatic enzymes might play a role in cancer prevention and treatment.

Research has confirmed that trophoblast cells and cancer cells use similar mechanisms to invade and create a blood supply.¹¹ More recent studies demonstrate receptors for proteases on the surfaces of both types of cells.^12,13

During Beard’s life, physicians used enzyme preparations with variable success, which Beard felt was due to the erratic quality of the products used. Quality, dosing, and patient non-adherence all make for challenges in implementing this form of therapy. For some patients, it is difficult to accept that treatment will have to continue for years. Our belief is that cancer develops due to inadequate pancreatic enzyme manufacture by the body, and that just as an insulin-dependent diabetic requires insulin indefinitely, many of our patients require some additional pancreas product indefinitely or the cancer will recur. Patient 2’s story illustrates this.

Some patients over the years have decided that only the pancreas product is important and that they could minimize or eliminate the following aspects of the protocol. Kelley, Nick, and I all found that those patients do not succeed.

Diet, supplements, and the autonomic nervous system. Dietary advice for all patients includes organic food, unprocessed and unrefined, with no white flour, white sugar, or inflammatory oils. Beyond that, in this model, different patients need different diets, from nearly vegetarian to a diet replete with animal protein and fat, in addition to root and cruciferous vegetables. Different patients also need different supplement protocols, with the vegetarian patients doing well with magnesium and potassium, the carnivores needing more calcium.

The model is based on Kelley’s clinical observations, with support from the work of Dr. Francis Pottenger and Dr. Ernst Gellhorn.^14,15 The two parts of the autonomic system, the sympathetic “fight-flight-freeze” system and the parasympathetic “rest-digest” system, ideally operate in a balanced way. Genetic predisposition, environmental stressors and aging can push one system or the other to be overactive, resulting in poor health. Health can be improved by improving the balance of the autonomic system.

The sympathetic nervous system can be toned down by an alkalinizing diet and by magnesium and potassium but is stimulated by calcium. Patients with an overactive parasympathetic system tend to be too alkaline and do well with red meat, fat, and supplemental calcium. Patients whose metabolism is balanced need a variety of foods and moderate amounts of magnesium, potassium, and calcium. A detailed explanation of this, with a review of Pottenger’s and Gellhorn’s work, can be found in Nick’s book Nutrition and the Autonomic Nervous System.¹⁶

Kelley predicted that an overactive sympathetic system contributes to carcinomas, such as lung, breast, pancreas, colon or prostate cancer. Patients with an overactive parasympathetic system would develop cancers of the immune system, such as myeloma, leukemia, and lymphoma.

Nick told me once that the principles of autonomic imbalance could help make sense out of many of the bits and pieces that would float past in the medical and nutritional literature. As an example, researchers have found that breast cancer patients who were prescribed beta-blockers (for reasons other than breast cancer, such as hypertension or heart disease) do better than patients who were not prescribed this medication.¹⁷ In Kelley’s model, breast cancer patients have an overactive sympathetic nervous system, and beta-blockers specifically block the beta-adrenergic receptor of the sympathetic nervous system, bringing these patients’ metabolisms closer to balance.

In another study, administration of calcium supplements slightly raised the risk of heart attack.¹⁸ A subsequent article, pooling the results of many studies, suggested that there was no such increased risk.¹⁹ Calcium, as a stimulator of the sympathetic nervous system, could well be an instigator of heart attacks if given to patients whose sympathetic nervous systems are already too active. In the Kelley model, patients with overactive parasympathetic nervous systems need and thrive on high doses of calcium supplements, while patients with overactive sympathetic systems need very little. The patients in the study showing increased risk might well have been made up mostly of those with overactive sympathetic systems. Larger analyses, pooling data from many studies with patients of a variety of metabolic types, would show no risk.

In contrast to Kelley, Nick and myself, others in the integrative nutritional world state that everyone should be on the same diet, which might be anywhere from vegan to low-carb—usually the diet that the prescribing practitioners feel best eating for themselves. With our methods, I will find myself recommending for some patients a diet with less animal protein than works for me, and for others a diet with much much more. Two of my patients, who were included in our 2007 article in Alternative Therapies in Health and Medicine,² illustrate this point; one, with pancreatic cancer, was told to eat a near-vegetarian diet, the other, with lymphoma, was told to eat large amounts of animal protein. Both patients are alive and well today, twenty years or more since diagnosis. Each continues to eat the prescribed diet with relish. The vast majority of the time, patients feel well with the recommendations we give.

Many other nutritional supplements besides magnesium, potassium and calcium have an effect on autonomic nervous system balance as well, which is why I warn my patients not to add to or modify their protocol without talking to me first. Emotional states and stress are also important, since negative emotions can activate the sympathetic nervous system powerfully.²⁰

Detoxification. Detoxification, primarily with the use of coffee enemas, is the third component of the work I do. Coffee enemas were widely used in mainstream medicine in the nineteenth and the first half of the twentieth century for the treatment of poisoning and in postoperative care.^21-27 Theoretically, coffee enemas stimulate bile flow from the liver and gallbladder, thereby assisting removal of wastes. Support for this comes from a 2014 article describing their use in clearing bile prior to capsule endoscopy.²⁸ Alternative Therapies in Health and Medicine recently published an article of mine reviewing this subject.²⁹

Kelley found that pancreatic enzyme ingestion could lead to flu-like symptoms that were relieved by coffee enemas, and so he incorporated them as a key component of his treatment regimen. On a practical level, Nick and I have had patients decide that the enemas were unnecessary, and none have done well. Most patients immediately feel better when they do them, so compliance with this aspect is better than I would have predicted before I tried them myself. However, some patients cut corners because of the time it takes, as well as a fundamental lack of appreciation of the importance of detoxification. Dietary quality and avoidance of environmental pollutants also fit into the category of detoxification, because bringing in unnecessary toxins slows the whole process down.

Conclusion

In an ideal world, methodologies that look promising in case reports are then evaluated in a formal clinical trial.³⁰ Nick and I tried our best, starting with a pilot study in pancreatic cancer published in 1999.³¹

The clinical trial that followed was, in our opinion, rendered worthless because of problems in study design, mismanagement, and poor compliance on the part of the majority of the patients enrolled.^32,33 The academic researchers involved did not discuss compliance in their publication of the results, even though this had been discussed extensively as the trial progressed.^34,35 The oncology community was profoundly unsupportive of the trial, and I believe this affected patient compliance with the protocol.

Nick and I have focused on publication of case reports over the years, but one of the most common questions, from both patients and other practitioners, has been, “What is your success rate?” Understandably, patients want to know what the likelihood of success is for their particular situation. Unfortunately, it is a question that is impossible to answer in a scientifically rigorous and responsible way, due to a heterogeneous patient population, variations in adherence, and difficulty finding an appropriate comparison group in the medical literature. Nick and I addressed this in the last article we wrote together, published a few months before his death in 2015.³⁶

My goal in continuing to practice and publish case reports is to keep this work alive to help interested patients with no curative options, or those who have completed their orthodox therapy. It is my hope that one day the medical world will be more receptive and willing to fairly investigate the results.

References

1. Gonzalez NJ. One Man Alone; An Investigation of Nutrition, Cancer, and William Donald Kelley. New York, NY: New Spring Press; 2010.

2. Gonzalez NJ, Isaacs LL. The Gonzalez therapy and cancer: a collection of case reports. Altern Ther Health Med. 2007;13(1):46-55. Available at: http://www.alternative-therapies.com/at/web_pdfs/gonzalez1.pdf.

3. Gonzalez NJ. Conquering Cancer: Volume One. New York, NY: New Spring Press; 2016.

4. Gonzalez NJ. Conquering Cancer: Volume Two. New York, NY: New Spring Press; 2017.

5. Isaacs LL. An enzyme-based nutritional protocol in metastatic cancer: case reports of a patient with colon cancer and a patient with lung cancer. Altern Ther Health Med. 2019;25(4):16-19. Available at: https://www.drlindai.com/Alt-ther-7-2019.pdf.

6. Simmonds PC. Palliative chemotherapy for advanced colorectal cancer: systematic review and meta-analysis. Colorectal Cancer Collaborative Group. BMJ. 2000;321(7260):531-535.

7. Hu C, Chang EL, Hassenbusch SJ, et al. Nonsmall cell lung cancer presenting with synchronous solitary brain metastasis. Cancer. 2006;106(9):1998-2004.

8. Gonzalez NJ. The History of the Enzyme Treatment of Cancer. Altern Ther Health Med. 2014;20(S2):30-44.

9. Gonzalez NJ, Isaacs LL. The Trophoblast and the Origins of Cancer: One solution to the medical enigma of our time. New York, NY: New Spring Press; 2009.

10. Beard J. The Enzyme Treatment of Cancer and Its Scientific Basis. London: Chatto and Windus; 1911.

11. Murray MJ, Lessey BA. Embryo implantation and tumor metastasis: common pathways of invasion and angiogenesis. Semin Reprod Endocrinol. 1999;17(3):275-290.

12. Bar-Shavit R, Maoz M, Kancharla A, et al. Protease-activated receptors (PARs) in cancer: Novel biased signaling and targets for therapy. Methods Cell Biol. 2016;132:341-358.

13. Even-Ram SC, Grisaru-Granovsky S, Pruss D, et al. The pattern of expression of protease-activated receptors (PARs) during early trophoblast development. J Pathol. 2003;200(1):47-52.

14. Pottenger FM. Symptoms of Visceral Disease. St. Louis, MO: C.V. Mosby Company; 1944.

15. Gellhorn E. Principles of Autonomic-Somatic Integrations: Physiological Basis and Psychological and Clinical Implications. Minneapolis, MN: University of Minnesota Press; 1967.

16. Gonzalez NJ. Nutrition and the Autonomic Nervous System: The scientific foundations of the Gonzalez Protocol. New York, NY: New Spring Press; 2017.

17. Barron TI, Sharp L, Visvanathan K. Beta-adrenergic blocking drugs in breast cancer: a perspective review. Ther Adv Med Oncol. 2012;4(3):113-125. Available at:

18. Xiao Q, Murphy RA, Houston DK, Harris TB, Chow WH, Park Y. Dietary and supplemental calcium intake and cardiovascular disease mortality: the National Institutes of Health-AARP diet and health study. JAMA Intern Med. 2013;173(8):639-646.

19. Waldman T, Sarbaziha R, Merz CN, Shufelt C. Calcium Supplements and Cardiovascular Disease: A Review. Am J Lifestyle Med. 2015;9(4):298-307.

20. Elefteriou F. Chronic stress, sympathetic activation and skeletal metastasis of breast cancer cells. BoneKEy reports. 2015;4:693.

21. Bedside procedures. In: Lyght CE, Keefer CS, Lukens FDW, Richards DW, Sebrell WH, Trapnell JM, eds. The Merck Manual of Diagnosis and Therapy. 11th ed. Rahway, NJ: Merck Sharp & Dohme Research Laboratories; 1966:1682-1683.

22. McClain ME. The patient’s needs: Enemas. Scientific Principles in Nursing. St. Louis, MO: The C.V. Mosby Company; 1950:168.

23. Stajano C. The concentrated coffee enema in the therapeutics of shock. Uruguayan Med Surg Special Arch 1941;29(3):1-27.

24. The Medicinal Employment of Coffee. The Sanitary Record. 1897;20:105S-106S. Available at: https://books.google.com/books?id=tS0TAAAAYAAJ.

25. Mississippi Valley Medical Association Society Proceedings. West Med Review. 1896;1(7):189-194. Available at: http://google.com/books?id=tOVXAAAAMAAJ.

26. Allison CC. Operative Technique in Appendicitis, with Cases. West Med Review. 1896;1(6):152-154. Available at: http://google.com/books?id=tOVXAAAAMAAJ.

27. Cachot MA. Case of Poisoning by Aconite; Enema of Coffee in the Treatment. Pac Med Surg J 1866;9:239-240. Available at: http://google.com/books?id=BkAgAQAAIAAJ.

28. Kim ES, Chun HJ, Keum B, et al. Coffee enema for preparation for small bowel video capsule endoscopy: a pilot study. Clinical nutrition research. 2014;3(2):134-141. Available at: https://e-cnr.org/Synapse/Data/PDFData/9994CNR/cnr-3-134.pdf.

29. Isaacs LL. Coffee Enemas: A Narrative Review. Altern Ther Health Med. 2021;27(3):46-49.

30. Isaacs LL. Evaluating anecdotes and case reports. Altern Ther Health Med. 2007;13(2):36-38. Available at: http://www.alternative-therapies.com/at/web_pdfs/isaacs.pdf.

31. Gonzalez NJ, Isaacs LL. Evaluation of pancreatic proteolytic enzyme treatment of adenocarcinoma of the pancreas, with nutrition and detoxification support. Nutr Cancer. 1999;33(2):117-124. Available at: http://www.ncbi.nlm.nih.gov/pubmed/10368805.

32. Gonzalez NJ. What Went Wrong: The Truth Behind the Clinical Trial of the Enzyme Treatment of Cancer. New York, NY: New Spring Press; 2012.

33. Isaacs LL. Research Battles: Survival Tips From a Veteran. Integr Med (Encinitas). 2015;14(5):30-32. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4712871/.

34. 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. 2010;28(12):2058-2063.

35. Engel LW. 2005. Available at: https://www.drlindai.com/engel.pdf.

36. Gonzalez NJ, Isaacs LL. Statistics: Why Meaningful Statistics Cannot Be Generated From a Private Practice. Altern Ther Health Med. 2015;21(2):11-15.