714-X (PDQ®): Complementary and alternative medicine - Health Professional Information [NCI]

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714-X

Purpose of This PDQ Summary

This PDQcancer information summary for health professionals provides comprehensive, peer-reviewed, evidence-based information about the use of 714-X as a treatment for cancer. The 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 714-X research.
  • Possible side effects of 714-X 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 714-X as a treatment for cancer. The summary includes a brief history of the development of 714-X; a review of laboratory, animal, and clinical research; and possible side effects of 714-X use.

This summary contains the following key information:

  • The main ingredient of 714-X is naturally derived camphor that is chemically modified by the introduction of a nitrogen atom.
  • It is claimed that 714-X protects and stabilizes the immune system and restores its ability to fight cancer.
  • No study of 714-X has been published in a peer-reviewed scientific journal to show it is safe or effective in treating cancer.
  • 714-X is not approved for use in the United States.
  • The U.S. Food and Drug Administration has placed an import ban on 714-X.

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

714-X was developed more than 30 years ago in a privately funded laboratory in Quebec, Canada, where it continues to be produced. The primary component of 714-X is naturally derived camphor that is chemically modified by the introduction of a nitrogen atom. After modification, the camphor is combined with water and sodium chloride (i.e., salt). Numerous trace elements have also been found in batches of 714-X.[1] Reviewed in [2]

The private laboratory markets 714-X worldwide through its own distribution company.[1] In Canada, this compound is legally available on compassionate grounds only and must be obtained through a physician.[1] Reviewed in [2] Because the production of 714-X is not regulated, there is no guarantee that rigorous quality control procedures are followed to ensure manufacturing consistency or product safety. The U.S. Food and Drug Administration (FDA) has not approved 714-X for use as a treatment for cancer or any other medical condition. In addition, the FDA has placed an import ban on 714-X.

Before researchers can conduct clinicaldrug research in the United States, they must file an Investigational New Drug (IND) application with the FDA. The IND application process is confidential, and information about an IND can be disclosed only by the applicants. To date, no investigators have announced that they have applied for an IND to study 714-X as a treatment for cancer.

714-X is usually administered by injection near lymph nodes in the groin. It can also be administered nasally, using a nebulizer.Nasal administration is used for follow-up treatment and for the treatment of patients with lung or oral cancers. The producers of 714-X do not recommend intravenous or oral administration. A usual treatment cycle consists of a single daily injection for 21 days followed by a 2- to 3-day rest period. Between 6 and 12 treatment cycles have been recommended by the producers. The producers of 714-X advise a 50% reduction in dose for pediatric patients who weigh less than 30 kg (66 lb).[1] Reviewed in [2]

It has been suggested that 714-X is more effective if administered early in the disease process and before surgery, chemotherapy, or radiation therapy. The producers claim, however, that 714-X can also be used in conjunction with conventional treatments. It has been further suggested that the use of alcohol and treatment with nonconventional therapies such as shark or bovine (i.e., cow) cartilage (and other angiogenesis inhibitors), vitamin B12 supplements, and vitamin E supplements be avoided during 714-X treatment.[1] Reviewed in [2]

References:

1. 714X Technical Data. Rock Forest, Canada: CERBE Distribution, Inc. Available online. Last accessed June 11, 2009.
2. Kaegi E: Unconventional therapies for cancer: 6. 714-X. Task Force on Alternative Therapeutic of the Canadian Breast Cancer Research Initiative. CMAJ 158 (12): 1621-4, 1998.

History

Little documentation exists regarding the development of 714-X and its mechanism of action. It appears to have been developed in the 1960s on the basis of earlier studies that used a high-magnification, dark-field microscope called a somatoscope. Reviewed in [1,2] With the somatoscope, researchers were able to examine living cells in samples of fresh blood and tissue taken from healthy individuals and individuals with serious diseases, including cancer.

The study of living cells (as opposed to the dead cells examined with a conventional light microscope or an electron microscope) led to the theory that microorganisms distinct from bacteria, viruses, and fungus exist normally in the blood and play a role in the development of cancer. These microorganisms, which were called somatids, are said to exist in multiple forms, some of which appear only in individuals affected by degenerative or malignant diseases. The forms associated with degenerative diseases or cancer reportedly secrete growth hormones and toxic substances that disrupt normal cellular metabolism and damage the immune system. In this compromised environment, cells that have become cancerous are allowed to proliferate. It was also suggested that cancer cells trap nitrogen, thereby depriving the rest of the body of the nitrogen needed for normal cellular metabolism. In addition, it was proposed that cancer cells secrete a toxic substance, cocancerogenic K factor, that further inhibits the immune system. Reviewed in [1,2]

The producers of 714-X state that cancer can be diagnosed, and its development and spread can be predicted by studying blood samples with the somatoscope. No evidence has been published in peer-reviewed scientific journals to support these proposals, and the somatidian theory of cancer development is not widely accepted.

714-X reportedly works by protecting, stabilizing, and reactivating the patient's immune system, so the body can defend itself against cancer cell growth and metastasis.[3] Reviewed in [1,2] 714-X is said to accomplish this, in part, by helping to increase the "fluidity" of lymph.[3] In addition, the camphor component of 714-X is purportedly attracted to cancer cells, where the added nitrogen is released, thus preventing malignant cells from depleting the nitrogen required by normal cells (including immune system cells) for proper metabolism and function. Reviewed in [1,2]

References:

1. Kaegi E: Unconventional therapies for cancer: 6. 714-X. Task Force on Alternative Therapeutic of the Canadian Breast Cancer Research Initiative. CMAJ 158 (12): 1621-4, 1998.
2. Hess DJ: Germ warfare: the case for bacteria as carcinogen. In: Hess DJ: Can Bacteria Cause Cancer? Alternative Medicine Confronts Big Science. New York: New York University Press, 1997, pp 7-48.
3. 714X Technical Data. Rock Forest, Canada: CERBE Distribution, Inc. Available online. Last accessed June 11, 2009.

Laboratory / Animal / Preclinical Studies

No laboratory study of the safety and/or effectiveness of 714-X has been published in scientific literature. A few animal experiments have been conducted, but the results of these experiments have not been reported in peer-reviewed scientific journals. The animal studies utilized a lymphosarcomatumor model in rats and lymphoma tumor models in dogs and cows. 714-X was not found to be effective as an anticancer treatment in these studies. Reviewed in [1]

A few laboratory and animal studies have suggested that camphor is able to enhance the response of the immune system to vaccine administration and to increase the sensitivity of tumorcells to radiation therapy.[2,3,4,5,6] In one series of studies, investigators used camphor vapors as a conditioned stimulus to promote an immune response.[2,3,4,5] These studies demonstrated that mice exposed to camphor vapors at the same time they received an antilymphoma vaccine showed decreased growth of transplanted lymphoma cells and increased survival when they were re-exposed to camphor vapors plus the vaccine or to camphor vapors alone, in comparison with mice re-exposed to only the vaccine.[2,3] These investigators also demonstrated that exposure to camphor vapors led to an increase in natural killer cells[4] and an increase in tumor-specific cytotoxic T cells.[5] Another study reported that breastadenocarcinoma cells transplanted under the skin of mice responded better to local radiation therapy when small doses of camphor were administered by intraperitonealinjection before the radiation treatment.[6]

Finally, researchers examined nine compounds, including a camphor-containing compound, for their ability to inhibit the activity of estrone sulfatase, an enzyme involved in the production of estrone, which is a precursor of the various forms of estrogen. Estrogens are thought to promote the growth of hormone-dependent breast cancer cells. The camphor-containing compound showed only modest inhibition of estrone sulfatase activity in human breast cancer cells grown in vitro.[7]

References:

1. Kaegi E: Unconventional therapies for cancer: 6. 714-X. Task Force on Alternative Therapeutic of the Canadian Breast Cancer Research Initiative. CMAJ 158 (12): 1621-4, 1998.
2. Hiramoto RN, Hiramoto NS, Rish ME, et al.: Role of immune cells in the Pavlovian conditioning of specific resistance to cancer. Int J Neurosci 59 (1-3): 101-17, 1991.
3. Ghanta VK, Hiramoto NS, Solvason HB, et al.: Conditioning: a new approach to immunotherapy. Cancer Res 50 (14): 4295-9, 1990.
4. Ghanta VK, Hiramoto NS, Solvason HB, et al.: Conditioned enhancement of natural killer cell activity, but not interferon, with camphor or saccharin-LiCl conditioned stimulus. J Neurosci Res 18 (1): 10-5, 1987.
5. Ghanta VK, Hiramoto NS, Soong SJ, et al.: Conditioning of the secondary cytotoxic T-lymphocyte response to YC8 tumor. Pharmacol Biochem Behav 50 (3): 399-403, 1995.
6. Goel HC, Roa AR: Radiosensitizing effect of camphor on transplantable mammary adenocarcinoma in mice. Cancer Lett 43 (1-2): 21-7, 1988.
7. Howarth NM, Purohit A, Reed MJ, et al.: Estrone sulfonates as inhibitors of estrone sulfatase. Steroids 62 (4): 346-50, 1997.

Human / Clinical Studies

No clinical studies (i.e., clinical trials, case series, or case reports) have been reported in peer-reviewed scientific journals to support the safety or the efficacy of 714-X. A number of anecdotal reports and testimonials have been published in newspapers and other nonmedical literature. The producers of 714-X state that they have tried to document the long-term experience of patients treated with this compound, but they have encountered difficulty in obtaining information from patients and their health care providers. Reviewed in [1]

References:

1. Kaegi E: Unconventional therapies for cancer: 6. 714-X. Task Force on Alternative Therapeutic of the Canadian Breast Cancer Research Initiative. CMAJ 158 (12): 1621-4, 1998.

Adverse Effects

It is claimed that 714-X is nontoxic in the manufacturer-recommended dose range.[1] Reviewed in [2] The only described side effects of treatment with this compound are local redness, tenderness, and swelling at injection sites. Reviewed in [2]

References:

1. 714X Technical Data. Rock Forest, Canada: CERBE Distribution, Inc. Available online. Last accessed June 11, 2009.
2. Kaegi E: Unconventional therapies for cancer: 6. 714-X. Task Force on Alternative Therapeutic of the Canadian Breast Cancer Research Initiative. CMAJ 158 (12): 1621-4, 1998.

Overall Level of Evidence for 714-X

To assist readers in evaluating the results of human/clinical studies of complementary and alternative medicine (CAM) treatments for cancer, a scoring system has been devised that allows studies of individual treatments to be ranked according to the strength of their evidence (i.e., their level of evidence). Not all studies, however, are given a level of evidence score. To be eligible, a study must:

  • Evaluate a therapeutic outcome(s), such as tumorresponse, improvement in survival, or carefully measured improvement in quality of life.
  • Be reported in a peer-reviewed scientific journal.
  • Have its clinical findings published in sufficient detail that a meaningful evaluation can be made.

Evidence from studies that do not meet these requirements is considered extremely weak. In addition to scoring individual studies, an overall level of evidence assessment is usually made.

Because no study of the use of 714-X in humans has been reported in a peer-reviewed scientific journal, no level of evidence analysis is possible for this treatment. Therefore, at this time, the use of 714-X as a treatment for cancer cannot be recommended outside the context of well-designed clinical trials.

For additional information about levels of evidence analysis, refer to Levels of Evidence for Human Studies of Cancer Complementary and Alternative Medicine.

Changes to This Summary (06 / 12 / 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.

More Information

ADDITIONAL INFORMATION ABOUT CAM THERAPIES

  • The National Center for Complementary and Alternative Medicine (NCCAM).
  • The National Cancer Institute Office of Cancer Complementary and Alternative Medicine (OCCAM).
  • CAM on PubMed, a special subset of the PubMed scientific literature database created through a partnership between NCCAM and the National Library of Medicine.

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This information is intended mainly for use by doctors and 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).

Date Last Modified: 2009-06-12

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