714-X (PDQ®): Integrative, alternative, and complementary therapies - Health Professional Information [NCI]

Overview

NOTE: The information in this summary is no longer being updated and is provided for reference purposes only.

This cancer information summary provides an overview of the use of 714-X as a treatment for people with 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 derived from camphor in a chemical reaction with ammonia and sodium chloride.
• 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.

Reference citations in some PDQ cancer information summaries may include links to external websites 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 websites, or of any treatment or product, by the PDQ Integrative, Alternative, and Complementary Therapies 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 ammonia chloride moiety. Numerous trace elements have also been found in batches of 714-X.[1,2]

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. [1,2] 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 clinical drug 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).[1,2]

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.[1,2]

References:

1. 714X Technical Data. Rock Forest, Canada: CERBE Distribution, Inc. Available online. Last accessed April 7, 2016.
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.[1,2] With dark-field microscopes, researchers are able to examine living cells in samples of fresh blood and tissue taken from healthy individuals and individuals with serious diseases, including cancer.

The developer of 714-X states that 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 fungi exist normally in the blood and play a role in the development of cancer. These microorganisms, which are 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.[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 that the body can defend itself against cancer cell growth and metastasis.[1,2,3] 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.[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 April 7, 2016.

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 lymphosarcoma tumor 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.[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 tumor cells 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 breast adenocarcinoma cells transplanted under the skin of mice responded better to local radiation therapy when small doses of camphor were administered by intraperitoneal injection 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.[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.[1,2] The only described side effects of treatment with this compound are local redness, tenderness, and swelling at injection sites.[2]

References:

1. 714X Technical Data. Rock Forest, Canada: CERBE Distribution, Inc. Available online. Last accessed April 7, 2016.
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.

Summary of the Evidence for 714-X

To assist readers in evaluating the results of human/clinical studies of integrative, alternative, and complementary therapies 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 tumor response, 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, a summary of the evidence 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 Integrative, Alternative, and Complementary Therapies.

Changes to This Summary (04 / 08 / 2016)

The PDQ cancer 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.

This summary is written and maintained by the PDQ Integrative, Alternative, and Complementary Therapies Editorial Board, which is editorially independent of NCI. The summary reflects an independent review of the literature and does not represent a policy statement of NCI or NIH. More information about summary policies and the role of the PDQ Editorial Boards in maintaining the PDQ summaries can be found on the About This PDQ Summary and PDQ® - NCI's Comprehensive Cancer Database pages.

About This PDQ Summary

Purpose of This Summary

This PDQ cancer information summary for health professionals provides comprehensive, peer-reviewed, evidence-based information about the use of 714-X in the treatment of people with cancer. It is intended as a resource to inform and assist clinicians who care for cancer patients. It does not provide formal guidelines or recommendations for making health care decisions.

Reviewers and Updates

This summary is reviewed regularly and updated as necessary by the PDQ Integrative, Alternative, and Complementary Therapies Editorial Board, which is editorially independent of the National Cancer Institute (NCI). The summary reflects an independent review of the literature and does not represent a policy statement of NCI or the National Institutes of Health (NIH).

Board members review recently published articles each month to determine whether an article should:

• be discussed at a meeting,
• be cited with text, or
• replace or update an existing article that is already cited.

Changes to the summaries are made through a consensus process in which Board members evaluate the strength of the evidence in the published articles and determine how the article should be included in the summary.

The lead reviewer for 714-X is:

• Jeffrey D. White, MD (National Cancer Institute)

Any comments or questions about the summary content should be submitted to Cancer.gov through the NCI website's Email Us. Do not contact the individual Board Members with questions or comments about the summaries. Board members will not respond to individual inquiries.

Levels of Evidence

Some of the reference citations in this summary are accompanied by a level-of-evidence designation. These designations are intended to help readers assess the strength of the evidence supporting the use of specific interventions or approaches. The PDQ Integrative, Alternative, and Complementary Therapies Editorial Board uses a formal evidence ranking system in developing its level-of-evidence designations.

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The preferred citation for this PDQ summary is:

PDQ® Integrative, Alternative, and Complementary Therapies Editorial Board. PDQ 714-X. Bethesda, MD: National Cancer Institute. Updated <MM/DD/YYYY>. Available at: https://www.cancer.gov/about-cancer/treatment/cam/hp/714-x-pdq. Accessed <MM/DD/YYYY>. [PMID: 26389421]

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Last Revised: 2016-04-08