Cancell/Entelev

Cancell/Entelev (PDQ)
Complementary/Alternative Medicine

Overview
General Information
History
Laboratory/Animal/Preclinical Studies
Human/Clinical Studies
Adverse Effects
Levels Of Evidence
Glossary Of Terms
References
For More Information

Overview

This complementary and alternative medicine (CAM) information summary provides an overview of the use of Cancell/Entelev as a treatment for cancer. The discussion in the summary is limited to Cancell/Entelev as it was originally conceived; the "vibrationally tuned" distilled water also distributed under the name Cancell will not be discussed. A glossary of scientific terms used in the summary appears just before the references. Terms defined in the glossary are marked in the text by hypertext links.

This summary contains the following key information:

Cancell/Entelev has been promoted by its manufactures as an effective therapy for cancer and a number of other diseases.
Cancell/Entelev 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/Entelev has been published in a peer-reviewed, scientific journal to show that it is safe or effective in treating cancer.
Cancell/Entelev is not approved for use in the United States.

General Information

Cancell/Entelev, also known by the names Sheridan's Formula, Jim's Juice, Crocinic Acid, JS-114, JS-101, 126-F, and Cantron, is a liquid that has been produced in various forms, principally by two manufacturers, since the late 1930s.[reviewed in 1-4] 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's disease, hemophilia, hypotension, hypertension, and some forms of epilepsy and mental illness.[reviewed in 1,3]

The exact composition of Cancell/Entelev 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/Entelev 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.[reviewed in 1] 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/Entelev, prohibiting them or their agents from distributing the mixture, which was judged an unapproved new drug.[reviewed in 1]

Cancell/Entelev can be administered orally or rectally, or it can be applied to the skin.[reviewed in 1] 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/Entelev.[reviewed in 1,3,4]

History

Cancell/Entelev was developed in the late 1930s by a chemist, who called it Entelev and provided it free of charge to terminal cancer patients.[reviewed in 1,3] In 1984, production was taken over by a second manufacturer, who distributed the mixture free of charge under the trademarked name Cancell to patients with cancer, AIDS, and other conditions.[reviewed in 1,3]

The two principal manufacturers of Cancell/Entelev 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."[4] 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, in contrast, use only 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/Entelev 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.[4] While the aerobic metabolism of normal cells is also inhibited by Cancell/Entelev, 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/Entelev 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, in general, 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 5-7] In addition, there is no scientific evidence that Cancell/Entelev or any of its components can cause cells to produce energy solely by glycolysis or is able to treat cancer effectively.[reviewed in 1,2] Furthermore, there is no evidence to date to support the existence of the bacterium P. cryptocides.[8]

Laboratory/Animal/Preclinical Studies

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

In 1990 and 1991, samples of Cancell/Entelev were evaluated under NCI's In Vitro Anticancer Drug Discovery Program. On the basis of negative results from these investigations, it was concluded that no further study of Cancell/Entelev was warranted.[reviewed in 1]

The principal manufacturers of Cancell/Entelev have stated that they have performed numerous animal experiments with the mixture, involving tens of thousands of mice.[reviewed in 1,3,4] However, the results of these experiments have not been published in peer-reviewed, scientific journals, and no information beyond stating that some of the experiments tested the toxicity of Cancell/Entelev has been provided.[reviewed in 4]

Human/Clinical Studies

The principal manufacturers of Cancell/Entelev have stated that the mixture has been used by more than 15,000 patients and that it is safe and effective in treating 50% to 80% of cancers.[reviewed in 1,3,4] 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/Entelev have been conducted.

Adverse Effects

The reported side effects of Cancell/Entelev include temporary, moderate fatigue during the first few weeks of treatment and nausea.[reviewed in 1,3] 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 3,4]

Levels of Evidence for Human Studies of Cancer Complementary and Alternative Medicine

To assist readers in evaluating the results of human studies of CAM 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 levels of evidence analysis, a study must 1) be published in a peer-reviewed, scientific journal; 2) report on a therapeutic outcome(s), such as tumor response, improvement in survival, or measured improvement in quality of life; and 3) describe clinical findings in sufficient detail that a meaningful evaluation can be made. No levels of evidence analysis could be performed for Cancell/Entelev 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 of CAM treatments for cancer, please click on the following link: Levels of Evidence Analysis for Human Studies of Cancer Complementary and Alternative Medicine.

Glossary of Terms

aerobic: In biochemistry, reactions that need oxygen to happen or happen when oxygen is present.

aerobic metabolism: A chemical process in which oxygen is used to make energy from carbohydrates (sugars). Also known as aerobic respiration, oxidative metabolism, or cell respiration.

AIDS: Acquired immunodeficiency syndrome. An acquired defect in immune system function caused by human immunodeficiency virus 1 (HIV-1). AIDS is associated with increased susceptibility to certain cancers and to opportunistic infections, which are infections that occur rarely except in individuals with weak immune systems.

anecdotal report: An incomplete description of the medical and treatment history of one or more patients. Anecdotal reports may be published in places other than peer-reviewed, scientific journals.

bacteria: A large group of single-cell microorganisms associated with infections and disease in animals and humans. The singular of bacteria is bacterium.

biochemical reactions: In living cells, chemical reactions that help sustain life and allow cells to grow.

bromelain: An enzyme found in pineapples that breaks down other proteins, such as collagen and muscle fiber, and has anti-inflammatory properties. It is used as a meat tenderizer in the food industry.

catechol: A chemical originally isolated from a type of mimosa tree. Catechol is used as an astringent, an antiseptic, and in photography, electroplating, and making other chemicals. It can also be man-made.

cell respiration: A chemical process in which oxygen is used to make energy from carbohydrates (sugars). Also known as aerobic metabolism, oxidative metabolism, or aerobic respiration.

cellular metabolism: The sum of all chemical changes that take place in a cell through which energy and basic components are provided for essential processes, including the synthesis of new molecules and the breakdown and removal of others.

clinical trial: A research study that evaluates the effectiveness of new interventions in people. Each study is designed to evaluate new methods of screening, prevention, diagnosis, or treatment of a disease.

collagen disease: A term previously used to describe chronic diseases of the connective tissue (e.g., rheumatoid arthritis, systemic lupus erythematosus, and systemic sclerosis), but now is thought to be more appropriate for diseases associated with defects in collagen, which is a component of the connective tissue.

complementary and alternative medicine: CAM. Forms of treatment in addition to (complementary) or instead of (alternative) standard treatments. These practices include dietary supplements, megadose vitamins, herbal preparations, special teas, massage therapy, magnet therapy, spiritual healing, and meditation.

cystic fibrosis: A common hereditary disease in which exocrine (secretory) glands produce abnormally thick mucus. This mucus can cause problems in digestion, breathing, and body cooling.

diabetes mellitus: A group of disorders in which there is a defect in the transfer of glucose (sugar) from the bloodstream into cells, leading to abnormally high levels of blood sugar (hyperglycemia).

dimethyl sulfoxide: A colorless liquid that readily dissolves many chemicals and penetrates animal and plant tissues. It is used in human medicine, veterinary medicine, and pharmaceuticals.

emphysema: Pulmonary emphysema is a disorder affecting the alveoli (tiny air sacs) of the lungs. The transfer of oxygen and carbon dioxide in the lungs takes place in the walls of the alveoli. In emphysema, the alveoli become abnormally inflated, damaging their walls and making it harder to breathe. People who smoke or have chronic bronchitis have an increased risk of emphysema.

epilepsy: A group of disorders marked by problems in the normal functioning of the brain. These problems can produce seizures, unusual body movements, a loss of consciousness or changes in consciousness, as well as mental problems or problems with the senses.

glycolysis: A process in which glucose (sugar) is partially broken down by cells in enzyme reactions that do not need oxygen. Glycolysis is one method that cells use to produce energy. When glycolysis is linked with other enzyme reactions that use oxygen, more complete breakdown of glucose is possible and more energy is produced.

hemophilia: Refers to a group of hereditary disorders in which affected individuals fail to make enough of certain proteins needed to form blood clots.

hypertension: Abnormally high blood pressure.

hypotension: Abnormally low blood pressure.

in vitro: In the laboratory (outside the body). The opposite of in vivo (in the body).

inositol: A type of sugar that differs from glucose in its chemical structure. Certain modified forms of inositol can be used by the body to transmit signals inside and between cells.

malignancy: A cancerous tumor that can invade and destroy nearby tissue and spread to other parts of the body.

metabolism: The total of all chemical changes that take place in a cell or an organism. These changes produce energy and basic materials that are needed for important life processes.

multiple sclerosis: A disorder of the central nervous system marked by weakness, numbness, a loss of muscle coordination, and problems with vision, speech, and bladder control. Multiple sclerosis is thought to be an autoimmune disease in which the body's immune system destroys myelin. Myelin is a substance that contains both protein and fat (lipid) and serves as a nerve insulator and helps in the transmission of nerve signals.

mutate: To change the genetic material of a cell. The changes (mutations) can be harmful, beneficial, or have no effect.

nitric acid: A toxic, corrosive, colorless liquid used to make fertilizers, dyes, explosives, and other chemicals.

oral: By or having to do with the mouth.

Parkinson's disease: A progressive disorder of the nervous system marked by muscle tremors, muscle rigidity, decreased mobility, stooped posture, slow voluntary movements, and a mask-like facial expression.

potassium hydroxide: A toxic and highly corrosive chemical used to make soap, in bleaching, and as a paint remover. It is used in small amounts as a food additive and in the preparation of some drugs.

quality of life : The overall enjoyment of life. Many clinical trials measure aspects of a person's sense of well-being and ability to perform various tasks in order to assess the effects that cancer and its treatment have on the person.

rectal: By or having to do with the rectum, which is the last 8 to 10 inches of the large intestine ending at the anus.

scleroderma: A chronic disorder marked by hardening and thickening of the skin. Scleroderma can be localized or it can affect the entire body (systemic).

sodium sulfite: A chemical used in photography, paper making, water treatment, and for other purposes.

sulfuric acid: A strong acid that, when concentrated, is extremely corrosive to the skin and mucous membranes. It is used in making fertilizers, dyes, electroplating, and industrial explosives.

systemic lupus erythematosus: SLE. A chronic inflammatory connective tissue disease marked by skin rashes, joint pain and swelling, inflammation of the kidneys, inflammation of the fibrous tissue surrounding the heart (i.e., the pericardium), as well as other problems. Not all affected individuals display all of these problems. May be referred to as lupus.

testimonials: Information given by individuals who state that they have been helped by a particular treatment or product. The information usually cannot be judged in a scientific way.

therapeutic: Used to treat disease and help healing take place.

References:

1. The American Cancer Society: Questionable methods of cancer management: Cancell/ Entelev. CA--A Cancer Journal for Clinicians 43(1):57- 62, 1993.

2. Cassileth BR: The Alternative Medicine Handbook: The Complete Reference Guide to Alternative and Complementary Therapies. New York: W. W. Norton & Company; 160-161, 19and other health care professionals. If you have questions about this topic, you can ask your doctor, or call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).

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