The Simone Report
NUTRIENTS AND CANCER TREATMENT
by Charles B. Simone, M.MS., M.D.,
with Nicole L. Simone, B.S.E., Charles B. Simone, II
copyright© 1999 Simone Protective Cancer Center
While thoroughly engrossed in basic science at the National
Cancer Institute as a Medical Oncologist and Tumor Immunologist,
I found new direction as a result of contacts with cancer patients. One of my first
patients was a Vice President of the United States who was dying of
malnutrition secondary to his cancer-as do 40% of all cancer patients.
Later, a man my own age with a rare cancer asked if I would keep him
alive until he saw the birth of his child. Intensive chemotherapy cleaned out
the cancer, but he failed to improve. As a last resort, I gave him high
doses of antioxidants and other vitamins and minerals that quickly produced a
seemingly miraculous, although temporary result. The man saw the birth
of his child.
Today's oncology care
Cancer will emerge as the number one cause of death in the
United States by the year 2000. Despite the enormous effort to combat cancer,
the number of new cases of nearly every form of cancer has increased
annually over the last century. Still worse, from 1930 to the present, despite
the introduction of radiation, chemotherapy, and immunotherapy with
biological response modifiers, despite CT scans, MR scans, and all the other new
medical technology, lifespans for almost every form of adult cancer have
remained constant, except cervical and lung cancer. This means, there has
been no significant progress in cancer treatment.
Although chemotherapy and radiation therapy continue to have a
role in cancer treatment, they produce morbidity. Nutritional modification,
including the use of antioxidants and other nutrients, and
proper lifestyle factors can
dramatically decrease morbidity and side effects of chemotherapy and
radiation therapy as well as increase response rates. Some reports have
shown that nutritional and lifestyle modification can actually increase
survival. It has been proven that chemotherapeutic agents and radiation
therapy reduce the serum levels of certain nutrients, especially
antioxidants. The decreased levels of these antioxidants result from
Augmenting treatment with nutrients
Do vitamins and minerals interfere with chemotherapy and/or
radiation therapy? I am frequently asked this by patients because they
have been advised not to take supplements during treatment. The scientific
literature has clearly addressed this question:
- The early clinical studies were performed at the National
Cancer Institute using an antioxidant called N-acetyl cysteine that was found
to protect the heart from the cardiac toxicity of adriamycin, but did not
interfere with the tumor-killing capability of the drug. An antioxidant,
dexrazoxane (ICRF-187), protects the heart from the effects of
adriamycin without affecting the antitumor effect. Cellular studies, animal
studies, and human studies demonstrate that vitamins A, E, C, and K,
beta-carotene and selenium, as single agents or in combination, all protect against
the toxicity of adriamycin and enhance its cancer-killing effects.
- In vitro cellular studies and animal studies using vitamins C,
A, K, E, D, B6, B12, beta-carotene, selenium, or cysteine as single agents
or in combination given concomitantly with chemotherapy, or tamoxifen, or
interferon alpha-2b, or radiation, or combinations of these modalities
show the same effect: Increased tumor killing and increased protection of
- Human studies involving over 1,960 patients have been done
using single or multiple nutrients in combination with systemic treatment
and/or radiation treatment demonstrating that nutrients produce a higher
response rate, lower side effects, and even increased survival.
- An increase in survival for cancer patients is uncommon with
any treatment. But an increase in survival has been demonstrated for
patients who received vitamin A or antioxidants in combination with chemotherapy
or radiation therapy. This finding was observed for patients with
myelodysplastic syndromes, breast cancer, gastric cancer, oral cavity
cancer, and upper aerodigestive cancers. Patients who were given
beta-carotene and anthaxanthin while undergoing surgery, chemotherapy,
and radiation lived longer with an increase in disease-free intervals. And
antioxidant treatment with chemotherapy and radiation prolonged survival
for patients with small cell lung cancer compared with patients who did
not receive antioxidants.
- The effects of one chemotherapeutic agent, methotrexate, can
be reversed with folinic acid, which is an analog of folic acid. Folic acid
itself does not reverse methotrexate's effects. In order to reverse the
effects of methotrexate, folinic acid has to be given in high doses.
Folinic acid cannot be obtained over-the-counter. It is only available
Efficacy of antioxidants
Antioxidants neutralize harmful chemicals called free radicals
that occur in the body and constantly arise from fatty foods, smoking,
alcohol, environmental pollutants, toxins, carcinogens, iron, smog, and
radiation. Free radicals attack vital cell structures and cause damage contributing
to the development of certain disease (i.e., cancer, cardiovascular,
Antioxidants protect normal cells and other tissues by fighting
free radicals and the oxidative reaction that is caused by free
radicals. Antioxidant nutrients include beta-carotene, vitamins C and E, selenium,
copper, zinc, bioflavonoids, and cysteine. There are now more than 200
studies that shown antioxidants can help decrease the risk of developing
One of the most recent investigations took place in Linxian, China.
Researchers from the Cancer Institute of the Chinese Academy of Medical
Sciences teamed up with researchers at the United States National Cancer
Institute and studied nearly 30,000 adults, randomized over a five-year
period into four different groups receiving different nutrients during
that period. Here is a brief summary of the study:
- It was the first large-scale intervention trial in a
prospective randomized fashion to demonstrate that three antioxidant nutrients
together-beta-carotene, vitamin E, and selenium-significantly reduced
total mortality (9%) especially from all cancers (13%) and particularly
stomach cancer (21%).
- These antioxidant nutrients also prevented the risk of cancer
- These antioxidant nutrients substantially reduced the
prevalence of cataracts in the oldest patients (aged 65 to 74 years).
- These antioxidant nutrients also reduced the mortality from
stroke. Many other studies demonstrated similar findings, including the
Finland Study, the Switzerland Study, the Hawaiian Study, and studies
involving people at high risk for developing endometrial cancer, breast
cancer, cervical cancer, small cell lung cancer, oral pharyngeal cancer,
and others. All studies show that protection is conferred to those who
consume antioxidants and other nutrients.
Studies of pre-cancerous conditions
Scores of studies, from all over the world, have shown that
antioxidants can decrease the risk of pre-cancerous lesions from
developing into a full-blown cancer.
The Linxian, China study investigated 3,300 patients with
esophageal dysplasia which is a precursor to developing esophageal
cancer. The same team of researchers from China and the United States examined
the results of the study, which was an intervention study, the best type of
clinical design. The group that received the multiple vitamin-mineral
supplement daily for six years had:
- lower mortality from esophageal and upper stomach cancers (8%)
- lower mortality rate in general (7%)
- lower rate of death from cancer in any site (4%)
- lower risk of dying of a stroke (38%)
While the duration of this trial was very short (six years) and
the doses of the nutrients were far too low compared to other trials, the
patients who took the supplements had much better results than the
control group of patients who took no supplements. Other studies show that
people who have colon polyps, abnormal cervical Pap smears, or other
pre-cancerous conditions, all do better and can reverse the trend toward a cancer if
they take certain antioxidants and other nutrients.
But what about beta-carotene specifically? There have been
reports from the CARET and ATBC studies that
beta-carotene increased the incidence of lung cancer
in heavin heavy smokers who drank alcohol and were exposed
to asbestos. I want to address this issue with the following thoughts:
- Over 200 studies have demonstrated that beta-carotene is safe
and can lower the risk of developing cancer and cardiovascular disease.
- All intervention studies show that beta-carotene and other
nutrients can decrease cancer rates and cancer progression.
- A total of 22 epidemiological studies that included
400,000 smokers and nonsmokers have shown those who had a high blood
level of beta-carotene had a lower
incidence and mortality of lung cancer. None of
these studies reported any association with an increased
incidence of lung cancer. In fact, the reduction in risk was even more
pronounced in smokers than in nonsmokers.
- The principal investigator has publicly said that the findings
are too preliminary to discuss and the data were not statistically
- The smokers in these studies who had high beta carotene
serum levels at the start of the study had the lowest incidence of lung
- Most of the study participants were alcoholics, and all of them
ate a high fat diet – both risk factors dramatically and
independently increase the risk of developing cancer..
- beta carotene did not increase the risk of lung cancer
for those who smoked less than 20 cigarettes a day and drank little or
- To my knowledge, no information was gathered concerning other
lifestyle risk factors that also would contribute to a poor outcome.
- Beta-carotene works most efficiently at the early stages of
carcinogenesis, not at the later stages when a cancer is already formed
– as was
the case with the patients in the CARET and ATBC
studies. Cancers are started between 10 and 20 years
before symptoms occur or our technology can detect them.
The fact remains, beta-carotene:
- is the most powerful antioxidant.
- neutralizes singlet oxygen, a powerfully damaging chemical.
- enhances immune system function.
- is very safe and nontoxic.
It is important to rely on the synergism of all the antioxidants,
including the carotenoids, and also the B’s,
etc., as well as lifestyle changes to decrease one’s risk of cancer and
heart disease. it is foolish to expect that a single nutrient can give
the “green light” to continue lifestyle behavior that will cause
Nutrition and lifestyle factors can profoundly reduce toxic side
effects and improve the results of conventional treatments. In a recent
study of 50 patients with early stage breast cancer, I evaluated the
treatment side effects of radiation alone, or radiation combined with
chemotherapy, while the patient took therapeutic doses of nutrients.
Patients also followed the Simone Ten Point Plan (see Table 1). The
patients were asked to evaluate their own response to the treatment in
terms of impacts of treatment on their quality of life. The major
behind our nutritional plan is that it contains a well-rounded supply of
antioxidants and immune enhancing nutrients. The results of the study
- More than 90% of both groups noted improvement in their
physical symptoms, cognitive ability, performance, sexual dysfunction, general
well-being, and life satisfaction.
- Not one subject in either group reported a worsening of
symptoms. Patients who follow the Ten Point Plan and use certain vitamins
andminerals report few side effects from chemotherapy and radiation
therapy. Twenty studies with more than 2,700 patients that investigated lifestyle
modification that includes dietary changes, nutrient supplementation,
and other lifestyle changes demonstrated a lower recurrence rate and an
increase in survival. The patients in these studies had the following
cancers: breast, ovarian, cervical, uterine, head and neck, lung,
pancreatic, prostate, and bladder.
Cancer patients should modify their lifestyles using the Ten
Point Plan, which includes modifying nutritional factors and taking certain
vitamins and minerals, especially if they are receiving chemotherapy
and/or radiation. The studies indicate that it is important to take the correct
nutrients to reduce side effects, enhance conventional therapies, and
increase outcomes (table 2).
The Simone Ten Point Plan:
- NUTRITION. Maintain an ideal weight-lose even 5 or 7 pounds if
Follow a low-fat (about 20%), high-fiber (25 gm) diet. Take specific
nutrients (see table 2). Eliminate salt, food additives and
preservatives, and caffeine.
- TOBACCO. Do not smoke, chew, snuff, or inhale other's smoke.
- ALCOHOL. Avoid alcohol.
- RADIATION. Avoid unnecessary X-rays and use sunscreens when in the
sun. Avoid electromagnetic fields.
- ENVIRONMENT. Keep air, water, and work place clean.
- HORMONES/DRUGS. Avoid all estrogens and unnecessary drugs.
- KNOW THE SEVEN WARNING SIGNS OF CANCER. Lump in breast, non-healing
sore, change in wart/mole, change in bowel or bladder habits, persistent
cough or hoarseness, indigestion or trouble swallowing, unusual
- STRESS MODIFICATION, SPIRITUALITY, AND SEXUALITY.
- HAVE AN EXECUTIVE PHYSICAL ANNUALLY.
Dr. Simone's recommended nutrients/dosages:
- Beta carotene = 20 to 30 mg per day
- Lutein = 10 TO 25 mcg per day
- Lycopene = 10 TO 25 mcg per day
- Vitamin E = 400 to 600 IU per day
- Vitamin C = 350 to 6,000 mg per day
- Bioflavonoids = 10 to 20 mg per day
- Selenium = 200 to 300 mcg per day
- Zinc = 15 to 20 mg per day
- Copper = 3 to 5 mg per day
- Cysteine = 20 to 500 mg per day
- Vitamin A = 5,000 to 7,500 IU per day
- Vitamin D = 400 to 600 IU per day
- Vitamin B1 = 10 mg per day
- Vitamin B2 = 10 mg per day
- Vitamin B6 = 10 mg per day
- Vitamin B12 = 18 mcg per day
- Niacinamide = 40 mg per day
- Biotin = 150 mcg per day
- Pantothenic acid = 20 mg per day
- Folic acid = 400 mcg per day
- Iodine = 150 mcg per day
- Chromium = 125 mcg per day
FDA’s REVIEW PROCESS STRUCK DOWN
Princeton, NJ – Charles B. Simone, M.D., a medical oncologist, immunologist and radiation
oncologist at the Simone Protective Cancer Institute, continues to be a leader in health care matters
and Food and Drug Administration reform. In 1993 he was called upon to write the language that
led to the compromise in the US Senate and finally the House ensuring that all Americans have free
access to food supplements – the Dietary Supplement, Health and Education Act of 1994
Wins Landmark Case Against FDA
Charles B. Simone, M.D. was again called upon to help Emord and Associates win a landmark case
against the Food and Drug Administration. On January 15, 1999, the United States Court of
Appeals for the D.C. Circuit ruled as invalid the FDA's interpretation of the term "significant
scientific agreement" for pre-screening nutrient-disease relationship claims of nutritional supplements
- [Pearson v Shalala]. The Court found that the FDA’s interpretation of the term "significant
scientific agreement" has been "arbitrary and capricious" and "in violation of the Administrative
FDA Violates First and Fifth Amendments
The Court also held that FDA's four sub-regulations [21 C.F.R. § 101.71(a), (c), (e); and §
101.79(c)(2)(i)(G)] as invalid and in violation of the First and Fifth Amendments to the United States
Constitution. The First, because producers of dietary supplements are assertedly subject to a ‘prior
restraint’ on their protected speech the labeling of products. The Fifth, because the agency’s
approach is so vague as to deprive the producers of liberty (and property) without due process.
The U S Court of Appeals further stated: "It simply will not do for a government agency to declare
- without explanation - that a proposed course of private action is not approved. The agency must
articulate a satisfactory explanation for its action. To refuse to define the criteria it is applying is
equivalent to simply saying no without explanation. Accordingly, on remand, the FDA must explain
what it means by ‘significant scientific agreement’ or, at minimum, what it does not mean."
Do we always need to tell patients the truth?
Charles B. Simone, M.D., Nicole L. Simone, B.S.E.,
Charles B. Simone, II Lancet. 1998; 352: 1787.
Hassn and Hassan wrote their opinion that "the wish of patients to know the whole truth about their
illness does not mean that it is right for them... on the contrary, it harms many of them"(1). However,
a survey found that 96 percent of Americans wanted to be told if they had cancer and 85 percent
wanted to know how long they would live if their cancer usually led to death in less than a year (2).
Moreover, a legal case involving ethical informed consent (Arato v. Avedon ) asked whether the
law should force physicians to report statistical life expectancy information to patients. Mr. Arato
had pancreas cancer that was treated surgically, then with experimental chemotherapy and radiation
because there "is no effective treatment." The surgeon and oncologist never told Mr. Arato and his
wife that only 5 percent survive for 5 years, nor did they give a prognosis or estimate of his life
expectancy, nor were they asked. A recurrence occurred and the physicians knew he would die
within a few months, but did not tell the patient about life expectancy.
The patient died and his wife sued the physicians claiming that the doctors were obligated under
California’s informed consent law to tell the patient about survival figures before asking him to
consent to chemotherapy. The court decided Mr. Arato should have been informed. The physicians
said if the patient knew of the high mortality rate, he would have no hope. And during the 70 visits,
the patient did not ask questions about his life expectancy indicating to the physicians that he did not
want to know. The patient’s wife said had the patient known the facts, he would have declined all
treatment and attended to his business affairs. His wife incurred tax losses due to poor business
The lower court favored the physicians. The appeal court reversed the decision. The California
Supreme Court upheld the decision in favor of the wife because of the doctrine of informed consent
based on four tenets:
- Patients are generally ignorant of medicine.
- Patients have a right to control their own bodies and thus to decide about medical treatment.
- To be effective, consent to medical treatment must be informed.
- Patients are dependent upon their physicians for truthful information and must trust them (making
the doctor-patient relationship a "fiduciary" or trust relationship rather that an arm’s length business
The court concluded that "the physician is under a legal duty to disclose all material information -
information regarded as significant by a reasonable person in the person’s position when deciding to
accept or reject a recommended medical procedure - needed to make an informed decision
regarding a proposed treatment."
The practice of medicine is an art as well as a science. It involves compassion and honesty. A good
physician will always give a ray of hope as well as discuss the implications of a grave situation.
Charles B. Simone, M.D., Nicole L. Simone, BSE, Charles B. Simone, II.
Simone Protective Cancer Center
123 Franklin Corner Road Lawrenceville, NJ 08648 USA
- Hassn AMF, Hassan A. Do we always need to tell patients the truth? Lancet. 1998; 352:1153.
- President’s Commission for the Study of Ethical Problems in Medicine. Making Health Care
Decisions. 1982; 2: 245-246.
- Arato v. Avedon. 5 Cal 4th 1172, 23 Cal Rptr. 1993. 2D. 131, 858P. 2D 598.