Cancell/Cantron/Protocel (PDQ®): Complementary and alternative medicine - Health Professional Information [NCI]

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Cancell/Cantron/Protocel

Purpose of This PDQ Summary

This PDQcancer information summary for health professionals provides comprehensive, peer-reviewed, evidence-based information about the use of Cancell/Cantron/Protocel as a treatment for cancer. This summary is reviewed regularly and updated as necessary by the PDQ Cancer Complementary and Alternative Medicine Editorial Board.

Information about the following is included in this summary:

  • A brief history of Cancell/Cantron/Protocel research.
  • Possible side effects of Cancell/Cantron/Protocel use.

This summary is intended as a resource to inform and assist clinicians and other health professionals who care for cancer patients. It does not provide formal guidelines or recommendations for making health care decisions.

Some of the reference citations in the summary are accompanied by a level of evidence designation. These designations are intended to help the readers assess the strength of the evidence supporting the use of specific interventions or treatment strategies. The PDQ Cancer Complementary and Alternative Medicine Editorial Board uses a formal evidence ranking system in developing its level of evidence designations. These designations should not be used as a basis for reimbursement determinations.

This summary is also available in a patient version, which is written in less technical language.

Overview

This complementary and alternative medicine (CAM) information summary provides an overview of the use of Cancell/Cantron/Protocel as a treatment for cancer. The discussion in the summary is limited to Cancell/Cantron/Protocel as it was originally conceived; the "vibrationally tuned" distilled water also distributed under the name Cancell will not be discussed.

This summary contains the following key information:

  • Cancell/Cantron/Protocel has been promoted by its manufacturers as an effective therapy for cancer and a number of other diseases.
  • Cancell/Cantron/Protocel is a mixture of common chemicals, none of which is known to be effective in treating any type of cancer.
  • No animal study or human study of Cancell/Cantron/Protocel has been published in a peer-reviewed scientific journal to show that it is safe or effective in treating cancer.
  • Cancell/Cantron/Protocel is not approved by the FDA for use in the United States as a treatment for a disease. There is a permanent injunction against distribution.

Many of the medical and scientific terms used in the summary are hypertext linked (at first use in each section) to the NCI Dictionary of Cancer Terms, which is oriented toward nonexperts. When a linked term is clicked, a definition will appear in a separate window. All linked terms and their corresponding definitions will appear in a glossary in the printable version of the summary.

Reference citations in some PDQ CAM information summaries may include links to external Web sites that are operated by individuals or organizations for the purpose of marketing or advocating the use of specific treatments or products. These reference citations are included for informational purposes only. Their inclusion should not be viewed as an endorsement of the content of the Web sites, or of any treatment or product, by the PDQ Cancer CAM Editorial Board or the National Cancer Institute.

General Information

Cancell/Cantron/Protocel, also known by the names Sheridan's Formula, Jim's Juice, JS-114, JS-101, 126-F, and "Cancell-like products", Cantron and Protocel, is a liquid that has been produced in various forms principally by two manufacturers since the late 1930s. Reviewed in [1,2,3] It has been promoted as an effective therapy for cancer and a wide range of other diseases including AIDS, collagen disease, lupus, scleroderma, cystic fibrosis, multiple sclerosis, adult-onset diabetes mellitus, emphysema, Parkinson disease, hemophilia, hypotension, hypertension, and some forms of epilepsy and mental illness. Reviewed in [1,3]

The exact composition of Cancell/Cantron/Protocel is unknown. The U.S. Food and Drug Administration (FDA) has listed the components as inositol, nitric acid, sodium sulfite, potassium hydroxide, sulfuric acid, and catechol. Reviewed in [1,2] The original manufacturer also identified "crocinic acid" as a component; Reviewed in [1] however, information about the nature and origin of this chemical has not been provided, and it does not appear to be a known compound. An independent analysis of one formulation of Cancell/Cantron/Protocel found 12 different compounds, none of which is known to be effective in treating any form of cancer. Reviewed in [1]

Before researchers can conduct clinical drug research in the United States, they must file an Investigational New Drug (IND) application with the FDA. Entelev, which is the original name of the mixture, was assigned an IND number (IND #20258) by the FDA in 1982.[4] The IND currently remains inactive because information about the product's composition and studies showing its therapeutic effectiveness in animals have not been provided to the FDA. Reviewed in [1] In 1989, the FDA was granted a permanent injunction against both principal manufacturers of Cancell/Cantron/Protocel prohibiting them or their agents from distributing the mixture, which was judged an unapproved new drug. Reviewed in [1]

Cancell/Cantron/Protocel has been administered orally,rectally, and topically. Reviewed in [1] Topical skin application is accomplished by dampening a cotton pad with the liquid and taping the moistened pad to the wrist or the ball of the foot after first treating the area with dimethyl sulfoxide. Reviewed in [1] Cancer patients have also been advised to take bromelain, which is a digestive aid, and to avoid high intakes of vitamins C and E while undergoing treatment with Cancell/Cantron/Protocel. Reviewed in [1,3]

References:

1. Questionable methods of cancer management: Cancell/Entelev. CA Cancer J Clin 43 (1): 57-62, 1993 Jan-Feb.
2. Cassileth BR, ed.: The Alternative Medicine Handbook: The Complete Reference Guide to Alternative and Complementary Therapies. New York, NY: WW Norton & Company, 1998.
3. Cancell Alternative Cancer Treatment. Available online. Last accessed June 16, 2009.
4. U.S. District Court for the Eastern District of Michigan.: Complaint for Permanent Injunction: United States of America, Plaintiff, v. James V. Sheridan and Edmund J. Sopcak, Defendants. 21st February, 1989.

History

Cancell/Cantron/Protocel was developed in the 1950s by a chemist who called it Entelev and provided it free of charge to patients with terminalcancer. Reviewed in [1,2] In 1984, production was taken over by a second manufacturer who distributed the mixture free of charge under the trademarked name Cancell to individuals with cancer, AIDS, and other conditions. Reviewed in [1,2]

The two principal manufacturers of Cancell/Cantron/Protocel have offered somewhat different explanations for cancer development, but their theories about how the mixture works are quite similar. According to the original manufacturer, human cells can be normal, cancerous, or primitive.[1] Each of these cellular forms is distinguished by the degree of oxygen utilization in cellular metabolism. Normal cells use aerobic metabolism (glycolysis plus additional biochemical reactions that require oxygen) to produce the energy needed for growth and maintenance. Primitive cells only use glycolysis, which is a much less efficient way to produce energy. It was proposed that normal cells become cancerous when, in response to certain damaging conditions such as chronic energy stress (a demand for energy greater than the cell's ability to produce it), they reach a critical point and begin to rely mainly on glycolysis to produce energy. According to this theory, cancerous cells still maintain many of the features of normal cells and cannot be recognized by the body as foreign. According to the original manufacturer, Cancell/Cantron/Protocel causes cancer cells to become completely primitive, i.e., their residual aerobic metabolism is inhibited and they produce energy solely by glycolysis. The resulting primitive cells are then seen by the body as foreign and destroyed. While the aerobic metabolism of normal cells is also inhibited by Cancell/Cantron/Protocel, they are too far removed from the critical point to become cancerous or completely primitive. Reviewed in [1]

The second manufacturer suggested that a bacterium called Progenitor cryptocides is involved in cancer development. Reviewed in [1] According to this theory, P. cryptocides becomes activated in individuals whose bodies are damaged by an improper diet. Once activated, this bacterium helps cause damaged normal cells to shift their energy production from aerobic metabolism to glycolysis. When the demand for energy exceeds the damaged normal cell's ability to produce it, the cell mutates and becomes cancerous. Once again, Cancell/Cantron/Protocel forces cancerous cells into a completely primitive state where they self-digest and are replaced by normal cells. The waste material produced by this self-digestion process is discarded by the body in a variety of ways: in urine, stool, vaginal discharge, or perspiration; it may also be vomited or coughed up. Reviewed in [1]

The idea that cancer cells show increased levels of glycolysis compared with normal cells is widely accepted, but this change in metabolism is not believed to be a fundamental cause of cancer development. Reviewed in [3,4,5] In addition, there is no scientific evidence that Cancell/Cantron/Protocel or any of its components can cause cells to produce energy solely by glycolysis or is able to treat cancer effectively. Reviewed in [1,6] Furthermore, there is no evidence to date to support the existence of the bacterium P. cryptocides.[7]

References:

1. Questionable methods of cancer management: Cancell/Entelev. CA Cancer J Clin 43 (1): 57-62, 1993 Jan-Feb.
2. Cancell Alternative Cancer Treatment. Available online. Last accessed June 16, 2009.
3. Mathupala SP, Rempel A, Pedersen PL: Aberrant glycolytic metabolism of cancer cells: a remarkable coordination of genetic, transcriptional, post-translational, and mutational events that lead to a critical role for type II hexokinase. J Bioenerg Biomembr 29 (4): 339-43, 1997.
4. Dang CV, Semenza GL: Oncogenic alterations of metabolism. Trends Biochem Sci 24 (2): 68-72, 1999.
5. Dills WL Jr: Nutritional and physiological consequences of tumour glycolysis. Parasitology 107 (Suppl): S177-86, 1993.
6. Cassileth BR, ed.: The Alternative Medicine Handbook: The Complete Reference Guide to Alternative and Complementary Therapies. New York, NY: WW Norton & Company, 1998.
7. Unproven methods of cancer management. Livingston-Wheeler therapy. CA Cancer J Clin 41 (3): A7-12, 1991 May-Jun.

Laboratory / Animal / Preclinical Studies

In 1978 and 1980, the National Cancer Institute (NCI) tested Cancell/Cantron/Protocel in animal studies and determined that the mixture lacked substantial antitumor activity. Reviewed in [1]

In 1990 and 1991, samples of Cancell/Cantron/Protocel were evaluated in NCI's in vitro 60 Human Tumor Cell Line Screen. The test results are available online. The graphs and the numerical designations for each of the three cancer cell growth criteria (GI50, concentration required for 50% inhibition of cell growth; TGI, concentration required for total inhibition of cell growth; and LC50, concentration required for 50% cell lethality or death) are somewhat complicated, but a technical explanation is provided in the Appendix. There is little evidence that any of the constituents of Cancell/Cantron/Protocel would be available in the bloodstream of a patient in significant concentrations after its ingestion. Activity was seen in two-thirds of the cell lines, though at levels that would be roughly 275 times higher than the theoretical maximum concentration achievable in serum. Therefore, the in vitro effects are likely due to nonspecific effects of changes in salt concentration. Furthermore, cells in the NCI Tumor Cell Line Screen are grown in artificial media under conditions that do not truly mimic the in vivo situation in animals or humans, and that results obtained with the screen may not accurately reflect possible effects in humans. To place the findings for Cancell/Cantron/Protocel in perspective any conventional drug exhibiting this low level of in vitro activity in the NCI human cancer cell line screen would normally not be investigated further by NCI.

The principal manufacturers of Cancell/Cantron/Protocel have stated that they have performed numerous animal experiments with the mixture involving tens of thousands of mice. Reviewed in [1,2] Results of these experiments, however, have not been published in peer-reviewed scientific journals and no information beyond stating that some of the experiments tested the toxicity of Cancell/Cantron/Protocel has been provided.

References:

1. Questionable methods of cancer management: Cancell/Entelev. CA Cancer J Clin 43 (1): 57-62, 1993 Jan-Feb.
2. Cancell Alternative Cancer Treatment. Available online. Last accessed June 16, 2009.

Human / Clinical Studies

The principal manufacturers of Cancell/Cantron/Protocel have stated that the mixture has been used by thousands of patients and that it is safe and effective in treating 50% to 80% of cancers. Reviewed in [1,2] The degree of effectiveness is said to vary with the type of malignancy. These findings, however, have not been published in peer-reviewed scientific journals and only testimonials and anecdotal reports have been provided. No clinical trials of Cancell/Cantron/Protocel have been reported.

References:

1. Questionable methods of cancer management: Cancell/Entelev. CA Cancer J Clin 43 (1): 57-62, 1993 Jan-Feb.
2. Cancell Alternative Cancer Treatment. Available online. Last accessed June 16, 2009.

Adverse Effects

The reported side effects of Cancell/Cantron/Protocel include temporary, moderate fatigue during the first few weeks of treatment and nausea. Reviewed in [1,2] One patient who exceeded the manufacturer's dose recommendations experienced diarrhea for a few hours but was reported to be fine the next day. Reviewed in [2]

References:

1. Questionable methods of cancer management: Cancell/Entelev. CA Cancer J Clin 43 (1): 57-62, 1993 Jan-Feb.
2. Cancell Alternative Cancer Treatment. Available online. Last accessed June 16, 2009.

Overall Level of Evidence for Cancell / Cantron / Protocel

To assist readers in evaluating the results of human studies of complementary and alternative medicine treatments for cancer, the strength of the evidence (i.e., the levels of evidence) associated with each type of treatment is provided whenever possible. To qualify for a level of evidence analysis, a study must:

  • Be published in a peer-reviewed scientific journal.
  • Report on a therapeutic outcome or outcomes, such as tumor response, improvement in survival, or measured improvement in quality of life.
  • Describe clinical findings in sufficient detail that a meaningful evaluation can be made.

No levels of evidence analysis could be performed for Cancell/Cantron/Protocel because no study of its use in humans has been published in a peer-reviewed scientific journal. For additional information about levels of evidence analysis, refer to Levels of Evidence for Human Studies of Cancer Complementary and Alternative Medicine.

Appendix

As noted previously (refer to the Laboratory/Animal/Preclinical Studies section of this summary for more information) samples of Cancell/Cantron/Protocel were evaluated in the National Cancer Institute's (NCI's) in vitro 60 Human Tumor Cell Line Screen in 1990 and 1991. In the screen, the cell lines are grown in artificial media under conditions that do not truly mimic the in vivo situation in animals or humans. The important information used in assessing a drug's effectiveness in the NCI in vitro screen includes drug concentrations necessary to achieve the following:

1. 50% inhibition of cell growth (GI50; the concentration needed to reduce the growth of treated cells to half that of untreated [i.e., control] cells).
2. 100% (total) growth inhibition (TGI; the concentration required to completely halt the growth of treated cells).
3. 50% cell kill or lethal concentration (LC50; the concentration that kills 50% of treated cells).

The log10 values for GI50, TGI, and LC50 for the 60 cell lines are available online.

The variations in log10 values for GI50 are 0.4 to 1.8 (mean = 1.15), equivalent to concentrations of 2.5 to 63 µg/mL (mean = 14); the variations in log10 values for TGI are 1.0 to 2.5 (mean = 1.62), equivalent to 10 to 320 µg/mL (mean = 41); and the variations in log10 values for LC50 are 1.6 to 3.9 (mean = 3.17), equivalent to 39 to 7,943 µg/mL (mean = 1,479).

Cancell/Cantron/Protocel Tumor Cell Line Screen Results

Parameter Measured 60 Cell-line Range (µg/mL) Mean (µg/mL)
50% growth inhibition (GI50) 2.5–63 14
Total growth inhibition (TGI) 10–320 41
Concentration for 50% lethality (LC50) 39–7,943 1,479
Maximum theoretical human plasma concentration (for comparison) 29 (calculated)

Based on the manufacturer's recommended doses of a marketed brand of Cancell/Cantron/Protocel it has been calculated that under idealized conditions of absolutely no loss of the constituents after administration to a patient (i.e., 100% bioavailability, meaning no loss due to degradation, absorption in the body, or rapid excretion—an unlikely situation), the maximum concentration that could be achieved in the plasma of an average 154-lb male is 29 µg/mL (antilog of 1.46). Thus, under these highly idealized conditions Cancell/Cantron/Protocel may exhibit some mild inhibitory effect on the growth of some cancer cells, but it would not be expected to inhibit their growth completely or to kill them. There is little evidence that any of the constituents of Cancell/Cantron/Protocel would be available in the bloodstream of a patient.

Changes to This Summary (07 / 23 / 2009)

The PDQcancer information summaries are reviewed regularly and updated as new information becomes available. This section describes the latest changes made to this summary as of the date above.

Editorial changes were made to this summary.

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Date Last Modified: 2009-07-23

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