Diet and Nutrition

Advocates of dietary cancer treatments typically extend mainstream assumptions about the protective effects of fruits, vegetables, fiber, and avoidance of excessive dietary fat in reducing cancer risk to the idea that foods or vitamins can cure cancer. Proponents of this belief make their claims in books with titles such as The Food Pharmacy: Dramatic New Evidence that Food is Your Best Medicine, Prescription for Nutritional Healing, and New Choices in Natural Healing. The chapter on cancer in a popular tome, Alternative Medicine, after criticizing chemotherapy, radiation, and surgery as “highly invasive…and may shorten the patient's life,” recommends that therapy instead address the entire body and employ a “nontoxic approach…incorporating treatments that rely on biopharmaceutical, immune enhancement, metabolic, nutritional, and herbal, nontoxic methods.”⁴⁶

Mind-Body Techniques

The potential to influence our health with our minds is an extremely appealing concept in the United States. It affirms the power of the individual, a belief intrinsic to American culture. Some mind-body interventions have moved from the category of alternative, unconventional therapies into mainstream medicine. Hypnosis and relaxation techniques are often used by conventional practitioners such as clinical psychologists. Several randomized trials have shown effects of hypnosis on both procedural and malignant pain.^53,54 There is also randomized trial evidence that relaxation and imagery reduce cancer pain.⁵⁵ A number of randomized trials have demonstrated positive effects of relaxation therapy on anxiety, depression, or mood in newly diagnosed cancer patients.^56–58 Relaxation training and hypnosis have been shown to have an effect on anxiety during treatment procedures, such as chemotherapy or bone marrow aspiration, in most^59,60 but not all⁶¹ randomized trials. In addition, hypnosis has been found effective for the treatment of anticipatory nausea in children.⁶² Trials have also generally found hypnosis and relaxation training to be beneficial against chemotherapy-induced nausea in adults,^63,64 although some studies find no differences between groups.⁶⁵

Music therapy is provided by professional musicians who are also trained music therapists. Typically they hold graduate degrees in music therapy, and are trained to deal with the psychosocial as well as clinical issues faced by patients and family members. Music therapy is particularly effective in the palliative care setting with randomized trials indicating benefit for reducing anxiety,^66–68 depression,^69,70 and pain.⁷¹

Some proponents argue that patients can use mental attributes and mind-body work to prevent or cure cancer. This belief is attractive because it ascribes to patients almost complete control over the course of their illness.⁷² Although they may involve small numbers of patients or remain unreplicated, studies suggesting that mental factors and prayer influence the course of cancer are widely publicized. An example is a 1989 Lancet article reporting that women with breast cancer who attended weekly support group sessions had improved survival as compared to women who did not attend.⁷³ Prospective replications of this randomized study have failed to find survival differences.^74,75

In some support groups, patients are encouraged to maintain positive attitudes and assume responsibility for their own health. The premise is that cancer results from unhealthy emotional patterns, correction of which can cure cancer or prolong remission. A careful case-control study, however, found no difference in length of survival between patients who attended the support groups versus those who did not, where patients in both groups had completed standard mainstream therapy for breast cancer.⁷⁶ Had these results been positive, the study no doubt would have received substantial publicity, but this refutation produced scant, if any, media attention.

Attending to the psychological health of cancer patients is a fundamental component of good cancer care. Support groups, good doctor-patient relationship, and the emotional and instrumental help of family and friends are vital. However, the idea that patients can influence the course of their disease through mental or emotional work is not substantiated and can evoke feelings of guilt and inadequacy when disease continues to advance despite patients' best spiritual or mental efforts.⁷²

Bioelectromagnetics

Bioelectromagnetics is the study of interactions between living organisms and their electromagnetic fields. According to proponents, magnetic fields penetrate the body and heal damaged tissues, including cancers and pain originating from localized musculoskeletal injuries.⁷⁷ These are bogus claims with no merit.

Alternative Medical Systems

This category includes ancient systems of healing typically based on concepts of human physiology that differ from those accepted by modern science. Two of the most popular healing systems are traditional Chinese medicine and India's Ayurvedic medicine, popularized by best-selling author Deepak Chopra.⁷⁸

The term Ayurveda comes from the Sanskrit words “ayur” (life) and “veda” (knowledge). Ayurveda's ancient healing techniques are based on the classification of people into one of three predominant body types. There are specific remedies for disease, and regimens to promote health, for each body type. This medical system has a strong mind-body component, stressing the need to keep consciousness in balance. It uses techniques such as yoga and meditation to do so. Ayurveda also emphasizes regular detoxification and cleansing through all bodily orifices.

There are said to be 10 Ayurveda clinics in North America, including one hospital-based clinic that has served 25,000 patients since 1985. The new Chopra Center for Well Being in La Jolla, California, offers a luxury spa setting for Ayurvedic treatments. The number of cancer patients who seek care at Ayurvedic clinics and spas is not documented.

Traditional Chinese medicine explains the body in terms of its relationship to the environment and the cosmos. Concepts of human physiology and disease are interwoven with geographic features of ancient China and with the forces of nature. Chi, the life force said to run through all of nature, flows in the human body through vertical energy channels known as meridians. Chi must flow in the correct strength and quality through each of the meridians and organs for health to be maintained. The most well-known method of altering the flow of Qi is acupuncture, the insertion of needles at special points on the meridians. Given modern understanding, acupuncture points are seen by some to correspond to physiologic and anatomic features such as peripheral nerve junctions or trigger points, which are areas of increased sensitivity within muscles that cause the characteristic patterns of referred pain. Although the very existence of chi or a “vital energy force” remains unproved, a substantial quantity of scientific research supports the value of acupuncture for the relief of pain and other symptoms.

One of the most intensively researched areas is nausea and vomiting where randomized, blinded, placebo-controlled trials consistently support the effectiveness of acupuncture as an antiemetic in pregnancy,⁷⁹ after anesthesia,^79,80 and during chemotherapy.^79,81 Evidence from systematic reviews of randomized trials indicates that acupuncture is effective for both acute⁸² and chronic pain.⁸³ No randomized trials of acupuncture for chronic cancer pain have been published, but several single-arm studies report that approximately half of patients in significant pain despite receiving optimal pharmacologic management obtain clinically relevant, persisting pain relief from acupuncture.^84–87

One explanation for the analgesic effects of acupuncture is that it stimulates release of endogenous opioids and other neurotransmitters. Seminal research conducted in the 1970s demonstrated that acupuncture induced analgesia in mice that could be blocked by naloxone.⁸⁸ Moreover, mice deficient in opiate receptors show poor electroacupuncture analgesia.⁸⁹ Levels of endogenous opioids in the cerebrospinal fluid have been directly observed to increase following acupuncture in humans.⁹⁰ There is preliminary evidence that acupuncture may lead to changes in the genetic expression of opioids, an observation that, if confirmed, may provide a basis for understanding the persisting effects of acupuncture treatment.⁹¹

In addition to acupuncture, basic therapeutic tools developed initially as part of traditional Chinese medicine include acupressure, qi gong, and tai chi. Tai chi is a well-documented, effective, gentle exercise technique, particularly useful in preventing falls among the frail or elderly.⁹² Traditional Chinese medicine also includes a full herbal pharmacopoeia with remedies for most ailments, including cancer.⁹³ Few such remedies have been subjected to careful study. Chinese herbal teas and relaxation techniques are soothing and appealing to many patients with cancer, who use them as complementary therapies. The potential anticancer benefits of Chinese green tea and other herbal remedies are under investigation.^94–96

Pharmacologic and Biologic Treatments

Because this group of alternative treatments is invasive and biologically active, it is highly controversial. Probably the best known and most popular pharmacologic therapy today is antineoplastons, developed by Stanislaw Burzynski and available in his clinic in Houston, Texas.⁹⁷ Laboratory analysis conducted by a respected scientist concluded that antineoplastons did not normalize tumor cells.⁹⁸ Early promising anecdotal reports encouraged a limited clinical trial for pediatric patients with brain tumors, but a joint research effort by the NIH Office of Alternative Medicine and the NCI failed to accrue sufficient numbers of patients, and none of the six patients assessable for response showed tumor regression.⁹⁹ Further research at the Burzynski Institute was permitted under an investigational new drug (IND) permit, but preliminary data recently were criticized by respected mainstream scientists as uninterpretable, and the therapy as useless and toxic.¹⁰⁰ Burzynski and his patients continue the antineoplaston therapy and remain vocal advocates of its efficacy.

For the public, the effectiveness of this treatment remains unclear. Although the therapy is unproved and outside the realm of mainstream medicine, many patients report anecdotal success. Moreover, researchers at the NCI and elsewhere continue to investigate phenylacetate, a metabolite of the amino acid phenylalanine, which makes up 80% of antineoplaston AS2.1. Recent results of a study conducted at the Memorial Sloan-Kettering Cancer Center indicate that “the safety profile and efficacy of phenylacetate make it an attractive agent for the treatment of pancreatic cancer,”¹⁰¹ and a Japanese investigation of three patients with advanced cancer concluded that “antineoplaston A10 and AS2.1 may be contributing to the rapid antitumor response.”¹⁰²

Immunoaugmentative therapy (IAT) was developed by the late Lawrence Burton, and offered in his clinic in the Bahamas. Injected IAT is said to balance four protein components in the blood and to strengthen the patient's immune system. According to proponent literature, Burton claimed that IAT was particularly effective in treating mesothelioma.¹⁰³ Documentation of IAT's efficacy remains anecdotal. The clinic has continued to operate following Burton's death, but its popularity seems to have waned.¹⁰⁴

Interest in shark cartilage as a cancer therapy was activated by a 1992 book by I. William Lane, Sharks Don't Get Cancer, and by a television special that displayed apparent remissions in patients treated with shark cartilage in Cuba. The televised outcome was strongly disputed by oncologists in the United States. Advocates base their therapy on its putative antiangiogenic properties.¹⁰⁵ A recent Phase I-II trial of shark cartilage found no clinical benefit,¹⁰⁶ but two large NIH-sponsored Phase III trials have been initiated.

The dwindling commercial success of shark cartilage as a treatment for cancer has led to its promotion for a different set of problems. Alternative medicine journals contain advertisements showing shark cartilage as “the most important joint decision you'll ever make. Your patients can now fight aging bone conditions. The secret is shark cartilage.” Because the advertisements avoid specific indication that the therapy can cure an ailment, they fall within the guidelines of the 1994 Food Supplement Act. Thus, the advertisements are permitted, even though there are no data concerning the safety or efficacy of this product as a treatment for any condition.

Cancell is another well-known biologic remedy that appears to be especially popular in Florida and the midwestern United States. Proponents claim that it returns cancer cells to a “primitive state” from which they can be digested and rendered inert. The FDA laboratory studies, which showed Cancell to be composed of common chemicals including nitric acid, sodium sulfite, potassium hydroxide, sulfuric acid, and catechol, found no basis for proponent claims of Cancell's effectiveness against cancer.¹⁰⁷

Manual Healing Methods

Osteopathic and chiropractic doctors were among the earliest groups to use manual methods. The value of chiropractic treatment of low back pain was supported by an NIH consensus conference,¹⁰⁸ but its value is widely disputed by mainstream physicians.¹⁰⁹ Today numerous manual healing techniques involving touch and manipulation are applied. Hands-on massage is one.¹¹⁰ The benefits of massage therapy are documented, especially for seriously ill and palliative care patients. Several randomized trials suggest that massage reduces anxiety, at least in the short-term, in groups as varied as adolescent psychiatric patients,¹¹¹ intensive care unit patients,¹¹² elderly people in care homes,¹¹³ and children suffering posttraumatic stress disorder.¹¹⁴ Data also indicate that massage improves psychological end points in cancer patients. In a highquality, if underpowered, trial, 35 patients were randomized to receive up to nine 20-min massages during inpatient stays or to standard care control. Massage was superior to control for anxiety, nausea, fatigue, and general well-being.¹¹⁵ In the largest study to date, 87 hospitalized cancer patients were randomized to foot massage or control. Pain and anxiety scores fell with massage, with differences between groups achieving both statistical and clinical significance.¹¹⁶

One of the most popular manual healing methods is therapeutic touch, which, despite its name, involves no direct contact. In therapeutic touch, healers move their hands a few inches above a patient's body and sweep away “blockages” to the patient's energy field. Although a study published in JAMA showed that experienced therapeutic touch practitioners were unable to detect the investigator's “energy field,”¹¹⁷ and despite mainstream scientists' unwillingness to accept its fundamental premises, therapeutic touch is taught in North American nursing schools and widely practiced by nurses in the United States and other countries.¹¹⁸

Related to therapeutic touch are the several therapies that involve manipulation of a putative human energy field or use of an individual's special gift for energy healing. Healing of this type, which has remained popular over the centuries in the less-developed areas of the world,¹¹⁹ has gained increasing public interest and acceptance in the United States. Healers in many areas of the United States claim the ability to cure people of cancer. Although their ministrations may cause only minor difficulties when patients also receive mainstream care, many patients are firmly convinced of these healers' abilities and decline even to have tumors removed surgically.

Herbal Remedies for Cancer

Herbal remedies typically are part of traditional and folk healing methods with long histories of use. Some form of herbal medicine is found in most areas of the world and across all cultures historically. Although many herbal remedies are claimed to have anticancer effects, only a few have gained substantial popularity as alternative cancer therapies.

For decades, Essiac has been one of the most popular herbal cancer alternatives in North America. Developed initially by a Native healer from southwestern Canada, it was popularized by a Canadian nurse, Rene Caisse (Essiac is Caisse spelled backwards). Essiac comprises four herbs: burdock, Turkey rhubarb, sorrel, and slippery elm. Researchers at the NCI and elsewhere found that it has no anticancer effect. Essiac is illegal in Canada, but it is widely available in American pharmacies and health food stores.

Iscador, a derivative of mistletoe, is a popular cancer remedy in Europe, where it is said to have been in continuous use as folk treatment since the druids. Iscador is available in many mainstream European cancer clinics. European governments have funded studies of Iscador's effectiveness against cancer, and results are starting to become available. No survival benefit has been found in patients with malignant melanoma¹²⁰ or head and neck cancer¹²¹. A small trial in glioma reported statistically significant differences between groups for one outcome in one subgroup¹²² but is flawed by multiple testing.

Pau d'arco tea is said to be an old Inca Indian remedy for many illnesses, including cancer. Made from the bark of an indigenous South American evergreen tree, its active ingredient, lapachol, has been isolated. Although lapachol showed antitumor activity in animal studies conducted in the 1970s, it does not appear to affect human malignancies. The tea does induce nausea and vomiting. Despite the absence of efficacy, pau d'arco tea is sold as a cancer remedy in health food stores, by mail, and on the Internet.

Asian herbal remedies show greater promise. Several mushroom-derived compounds are approved for use as cancer treatments in Japan and is there evidence of effectiveness in randomized Phase III trials. Most trials studied polysaccharide kureha (PSK), an extract of the mushroom Coriolus versicolor, or schizophyllan (SPG), which is extracted from the culture medium of Schizophyllum commune Fries. Trials typically compared chemotherapy or radiotherapy plus mushroom extract or conventional treatment alone, and found superior survival with PSK as compared to controls in both gastrectomy^123,124 and esophagectomy patients.¹²⁵ Two randomized trials of mushroom extracts given after curative resection for colorectal cancer have been conducted. In the first (n = 120), median survival in the PSK group was approximately 5 years, as compared to slightly over 4 years in controls.¹²⁶ The subsequent trial randomized 462 colorectal cancer patients scheduled for curative resection to chemotherapy (mitomycin C and 5-fluorouracil) alone or chemotherapy plus PSK.¹²⁷ Both disease-free and overall survival were significantly higher in the PSK group (3 year rates 77.2% vs 67.7% and 85.8% vs 79.25%). Results were less encouraging in breast cancer^128,129 and leukemia.¹³⁰ SPG was slightly but not significantly superior to control for gastrectomy, although a subgroup analysis showed improved survival in patients with curative resection.^131,132 The most encouraging results for SPG are found with cervical cancer, with trials demonstrating improvements in survival¹³³ and increased rates of tumor response.¹³⁴

PC-SPES (PC for prostate cancer; SPES is the Latin word for hope), a combination of eight herbs, all but one from traditional Chinese medicine, reduces prostate-specific antigen (PSA) levels in men with advanced prostate cancer regardless of whether disease is androgen-dependent.^95,135–137 Improvements in quality of life also have been reported.¹³⁷ The recipe came from a great-grandfather of one of the researchers, that ancestor having been a physician to the Chinese emperor. Estrogenic side effects occurred with PC-SPES, and its mechanism of action, although uncertain, may relate to its phytoestrogen effects. PC-SPES was suspended from the market in early 2002 when undisclosed contamination with anxiolytic and antithrombotic agents was uncovered.

Sho-saiko-to is a traditional Asian medicine for liver disease comprised of seven botanicals. It has demonstrated marked antiproliferative effects on various cancer lines, particularly hepatoma.¹³⁸ In a Phase III randomized trial, 260 patients with cirrhosis were randomized to treatment with Sho-saiko-to or control.¹³⁹ At 5 years, Sho-saiko-to led to a one-third reduction in the incidence of hepatocellular carcinoma (23% vs 34%) and a 40% reduction in deaths (24% vs 40%).

In a separate study, a formula of 19 vegetables from traditional Chinese medicine believed to have antitumor activity was added to the diets of 12 patients with stages III and IV non-small-cell lung cancer. Thirteen clinically similar patients were selected as controls. All patients received conventional therapies. The median survival of control patients was 4 months (mean 4.8 months). The median survival of patients who received the vegetable remedy was 15.5 months (mean 15 months). The completely nontoxic vegetable brew significantly improved quality and quantity of life.¹⁴⁰

These investigations suggest that historic herbal cancer remedies, pretested to ensure purity and consistency of product and studied carefully, may produce potentially useful, nontoxic cancer treatments. The difficulty with time-honored herbal remedies is that they are rarely tested for purity, examined for consistency, or studied carefully. They are, nonetheless, in common use. Herb sales in US drugstores and food stores increased 35% from 1993 to 1994, totaling $106.7 million for the year.¹⁴¹

Herbal Medicine

Cancer patients use over-the-counter herbal products in addition to or instead of those promoted specifically as cancer treatments. It is therefore important to recognize herbal remedies that may help cancer patients (Table 76-2) and those that are toxic or interact with other medications (Table 76-3). Because neither the FDA nor any other agency examines herbal remedies for safety and effectiveness, few products have been formally tested for side effects or quality control, but information is beginning to emerge on the basis of public experience with over-the-counter supplements.

Table 76-2

Herbal Products with Serious Toxic Effects.

Table 76-3

Important Potential Interactions Between Herbal Preparations and Conventional Drugs.

Recent reports in the literature describe severe liver and kidney damage from some herbal remedies (see Table 76-3). These reports underscore the fact that “natural” products, contrary to apparent consumer belief, are not necessarily safe or harmless.¹⁴² Most members of the public apparently are not aware that herbs are dilute pharmaceuticals, natural drugs that contain scores of different chemicals, most of which have not been documented. Effects are not always predictable.

Moreover, the potential for herb-drug interaction is sufficiently problematic that patients on chemotherapy should be told to stop using herbal remedies during treatment. Similar cautions are necessary for patients receiving radiation, as some herbs photosensitize the skin and cause severe reactions. Patients scheduled for surgery should be alerted to the fact that some herbs produce dangerous blood pressure swings and other unwanted interactions with anesthetics.¹⁴³ Herbs such as feverfew, garlic, ginger, and ginkgo have anticoagulant effects and should be avoided by patients on Coumadin, heparin, aspirin, and related agents. The risk of herb-drug interactions appears to be greatest for patients with kidney or liver problems.

Botanic remedies are sold in many forms, including capsules, liquids, and tea leaves. They may contain one or a collection of herbs and other ingredients, which typically are not described and often are unknown. The content of herbal remedies often differs widely from one bottle to the next.¹⁴⁴

The California Department of Health found unsafe levels of mercury and other toxic metals in more than a third of Asian patent medicines studied. Several instances of heart problems resulting from digitalis-contaminated supplements have been reported.¹⁴⁵ Concerns have been raised recently even about dietary antioxidants, which may interact with chemotherapeutic agents.¹⁴⁶

Regulatory and Safety Issues: Herbal Remedies and other Food Supplements

Dietary supplements, which include vitamins and minerals, homeopathic remedies, herbal treatments, antioxidants, and other over-the-counter products, are probably the most popular unconventional remedies used today by cancer patients as well as by the public in general. Supplement sales have steadily increased. According to the Nutrition Business Journal, 1998 sales of supplements sold over the Internet alone reached $40 million, an increase from $12 million in 1997. Nutrition Business Journal estimates sales of food supplements at $160 million for 1999 and $500 million in 2001.

No legal standards exist for the processing or packaging of herbs. Quality-control standards and reviews are needed. Because they are not mandatory, however, few food supplement companies voluntarily self-impose quality evaluation and control. Consumer protection and enforcement agencies cannot provide protection against contaminated or falsely advertised products. Current federal regulations do not permit such oversight, and regulatory capability would prohibit full analysis and ongoing oversight of the estimated 20,000 food supplement items now sold over the counter.

Nonetheless, Canada is establishing a federal office to evaluate and regulate herbal remedies, which it will treat as a new category distinct from drugs and foods. Organizations such as the American Medical Association and the American Cancer Society have produced position papers, and hearings have been held on food supplement issues by the FDA. The magnitude and seriousness of the problem probably will result in the establishment of government oversight programs of some kind, despite anticipated efforts on the part of the food supplement industry to block efforts that could lead to regulation.