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Testing

The Stegall Protocol is based on my desire to greatly improve the way we treat cancer.

There is a tendency to get tunnel vision and view cancer as merely a diseased organ. For example, with breast cancer, the tendency is to view the breast as the problem. However, using the weed-and-garden analogy, cancer is not just the problem of weeds but the soil itself which allowed the weeds to grow.

The foundation of my four pillars stems from my belief that cancer treatment should be personalized to each patient. I tell people every day that your cancer is as unique as your fingerprint.

PILLAR 1: Target cancer cells

Be careful not to harm the body while treating. Full-dose chemotherapy can do damage.
I do fractionated or small-dose chemotherapy – 10% to 20% of a full dose, given more often.

PILLAR 2: Stimulate the immune system

Immunotherapy is designed to harness the body’s immune system, to fight cancer by tagging cancer cells so the immune system views them as foreign. Sounds good, but the problem is that drugs can cause the immune system to be overactive – the body attacks itself. This is called autoimmune diseases. We have to be careful on how to stimulate the immune system and strike a delicate balance.

PILLAR 3: Protect the body’s healthy cells

Targeted chemotherapy and targeted treatments that include additional support for the body’s systems, including digestive, immune, endocrine, and nervous.

PILLAR 4: Nourish the soul

It’s easy to get caught up in the science, treatment, prognosis, etc. But why not use this process to truly nourish our souls? I spend time with my patients with Mind, Body, and Medicine. It’s the battlefield of the mind. Once you have wrapped your mind around your diagnosis and come up with a treatment plan, go for it. Don’t look back. Go for it with confidence.

Gathering Data

we need more than just your health history

Treating cancer with a holistic view

Cancer is a systemic disease. It must be treated while being aware of the tumor location and the body as a whole system. This holistic view is one of the foundational aspects of the Stegall Protocol and my approach to cancer.

Conventional treatment may cause short-term and long-term effects.

Short-term:

  • Fatigue
  • Headaches
  • Vision changes
  • Nausea and vomiting
  • Diarrhea
  • Constipation
  • And more

Long-term:

  • Neuropathy
  • Digestion issues that won’t go away
  • Toxicity
  • Risk of cancer
  • Radiation treatment effects

However, there is a better way to treat cancer. You don’t have to resort to toxic treatments. You have options. You’re in control of your treatments. You don’t have to be a passive participant in your cancer care.

Cancer is a powerful adversary, and we should have as much information about it as possible if we seek to be victorious over it. This data can take on many forms, including blood testing, urine testing, saliva testing, imaging, and the often-forgotten physical exam.

To effectively treat cancer, we need more than just your health history. This is where advanced lab testing comes in.

The first step is to obtain an accurate diagnosis, and this is done via a biopsy. After a biopsy confirms the presence of cancer, we must embark on a journey to obtain as much helpful information as possible. The more objective data we have at our disposal, the better.

Baseline Lab Testing

Laboratory testing can provide us with a significant amount of information, and ideally is the first place to start after being diagnosed with cancer. My baseline lab panel, which is performed via blood testing, consists of a very thorough investigation into how the body is working.

Below are some of the most important blood tests I order on my patients. Although all of these tests are readily available from most commercial labs, your oncologist probably will not be familiar with all of them. Hopefully, your oncologist is open-minded and thus is willing to have a conversation with you. If so, I encourage you to ask him or her if you can have some of these tests which might not be part of their routine panel.

Adrenal Profile

Cortisol is the body’s main stress response hormone, playing a role in the body’s “fight or flight” response. However, it is also involved in helping control blood sugar levels, reducing inflammation, and regulating metabolism. Cortisol is produced by the adrenal glands, which sit on top of the kidneys.

In today’s stressed-out society, cortisol is released far more often, and in much greater amounts, than it should be. This results in unhealthy stress on the adrenal glands, which can affect energy levels, immune system function, and hormonal balance. Blood testing for cortisol does not allow us to detect small fluctuations in cortisol levels, but saliva testing does.

The test is called a four-point salivary cortisol, which involves collecting saliva four times throughout the day.

I use the Temporal Adrenal Profile (TAP) from Diagnos-Techs lab in Washington. The patient is given a test kit, and collects saliva first thing in the morning, at noon, late afternoon, and at bedtime. The results are measured and compared to healthy cortisol levels. I frequently see abnormal levels, indicating that there is some degree of adrenal stress. It is important to correct this adrenal imbalance so that the body can function as it is supposed to.

Biocept

We know that cancer is not just a disease of the breast, colon, or prostate, but of the entire body. By the time a tumor is just several millimeters in size (much too small to be detected on a CT scan, PET scan, or MRI), it is already releasing what are known as circulating tumor cells into the blood. These circulating tumor cells, also known as CTCs, are cancer cells which ultimately lead to the progression and spread of cancer if not eliminated. Anyone who has had cancer — even someone who is in “remission” — will often have some level of CTCs. Thus, it is obvious that we should be measuring these cells, not only at the time a cancer diagnosis is made but also at regular intervals during and even after treatment. (1)

There are several tests which measure circulating tumor cells. Unfortunately, they use different methodologies, and most are of questionable reliability. Only one CTC test is FDA cleared, and that is the CELLSEARCH test. This test is readily available in the United States through most standard labs. It is approved to detect circulating tumor cells of breast, colorectal, and prostate origin. Those patients who are found to have some level of circulating tumor cells through this test have a worse prognosis.

Although the CELLSEARCH test is the only FDA cleared CTC test, I believe that the Biocept CTC test is the most accurate. Its advanced technology allows for a wide variety of CTCs to be measured, and thus provides the best evaluation of cancer’s systemic burden inside the body. Biocept is located in California, and typically has a turnaround time of just one week for results.

There are other circulating tumor cell analyses performed by labs outside the United States. The most well-known of these is the “Greek test,” developed by the Research Genetic Cancer Centre (R.G.C.C.) in Greece. The formal name of this test is Onconomics Plus. While it is not a diagnostic tool, the Onconomics Plus test can be used to analyze the number of circulating tumor cells. It uses a different methodology from the CELLSEARCH and Biocept CTC tests, so these results cannot be directly compared.

However, the Onconomics Plus test takes it a step further. After measuring the number of circulating tumor cells, it analyzes these cells for a variety of genetic markers, and then performs sensitivity testing in the lab to determine which chemotherapy agents and nutritional supplements kill these cancer cells the best. The Greek test is controversial in integrative oncology circles. Some providers feel that it is an excellent test, while others are suspicious as to its actual validity.

Although I believe it is a good test, I do have concerns about its prognostic capabilities. Even though we are evaluating a patient’s circulating tumor cells, and those cells’ response to various treatments, how well do those lab results correspond to what actually happens inside the body? As we know, the body is a very complex environment — much more complex than what we can replicate inside a petri dish.

Cancer Profile

The Cancer Profile, or CA Profile to which it is commonly referred, is a lab panel developed by Dr. Emil K. Schandl of American Metabolic Laboratories in Hollywood, FL. This test requires both blood and urine specimens, and measures several markers thought to be associated with and/or elevated in cancer. These include phosphohexose isomerase (PHI) enzyme, human chorionic gonadotropin (HCG), and carcinoembryonic antigen (CEA).

As is the case with other alternative lab tests, the CA Profile is not part of the standard of care. However, it can be helpful in monitoring the cancer burden in the body as well as the patient’s response to treatment.

Caris Molecular Intelligence

The Caris Molecular Intelligence test is an innovative test which analyzes a patient’s tissue for specific genetic alterations. This is a very convenient test, as Caris obtains the tissue from a pathology lab which contains a patient’s biopsy or surgical specimen. Once Caris receives the specimen, an in-depth analysis is performed to evaluate the presence and activity level of hundreds of genes. Based on the results, treatment decisions can be made regarding which pharmaceutical agents might be most effective.

I especially like this test because it is backed by excellent, up-to-date research. It allows for the ultimate in personalized cancer treatment, which is especially important when we are dealing with pharmaceutical agents.

IvyGene

The IvyGene test is a relatively new test which measures what is known as methylated DNA in the blood. The presence of methyl groups, which are a combination of a carbon and three hydrogens (-CH3), at specific sites within the genome are consistent with cancer. The IvyGene test helps identify the presence of cancer, and also provides a quantitative measure of disease. An IvyGene score of 19 or below is considered normal, while a score of 20 or more is considered elevated.

Although the IvyGene test is not diagnostic in nature, I do feel that it can be a valuable test to obtain at regular intervals to assess treatment progress. The lab is located in West Lafayette, Indiana. Insurance does not cover the test.

Micronutrient Testing

The Micronutrient Test by SpectraCell Laboratories measures the function of 35 vitamins, minerals, antioxidants, and amino acids within white blood cells. In addition, antioxidant function, as well as the immune system function, are assessed.

I like this test because it helps identify nutritional imbalances. We know that nutritional imbalance is quite common today, and by measuring these key nutrient levels in the body, we can correct any deficiencies and bring the body back into balance. Having the appropriate balance is critical for an optimally functioning immune system and efficient energy production by the body’s cells.

SpectraCell Laboratories is located in Houston, Texas. The Micronutrient Test is sometimes covered by insurance.

Organic Acids

The organic acids test (OAT) is a urine test which provides a comprehensive look at a patient’s metabolism and overall health. This is accomplished by measuring various organic acids, which are chemical compounds resulting from cellular energy production. This “metabolic snapshot” consists of more than 70 markers.

When abnormalities are detected using the OAT, they frequently provide explanations for common complaints including fatigue, digestive issues, and other immune system issues. Whether these abnormalities are a contributing factor for cancer development, a result of cancer itself, or a complication of prior cancer treatments, it is important to address these issues so that the body can function optimally at a cellular level.

Validation of Methods

evaluated for completeness, accuracy, and reliability

FDA-Approved Laboratories

For the patient’s peace of mind, testing is performed at Food and Drug Administration-approved labs. Bottom line: These labs are held to the highest standards.

The FDA, among other things, is responsible for protecting the public health by ensuring the safety, efficacy, and security of human drugs, biological products, and medical devices.

As part of the FDA’s effort to achieve uniformity and consistency in laboratory inspections, operations are evaluated by an experienced laboratory analyst with specialized knowledge.

In the United States, the development and marketing of commercial tests are regulated by the FDA. They are considered “medical devices” and, specifically, “in vitro diagnostic devices (IVD).” As such, they must be evaluated and approved by the FDA.

Information regarding the validation of methods is carefully evaluated for completeness, accuracy, and reliability. In particular, if a compendial method exists, but the firm chooses to use an alternate method, they must compare the two and demonstrate that the in-house method is equivalent or superior to the official procedure. For compendial methods firms must demonstrate that the method works under the actual conditions of use.

In the review of method validation data, it is expected that data for repetitive testing be consistent and that the varying concentrations of test solutions provide linear results.

Overall management of the laboratory work, its staff, and the evaluation of the results of an analysis are important in the evaluation of a controlled laboratory.

The process required for a new commercial test to gain approval for marketing by the FDA can be long and costly, sometimes taking many years, depending on how complicated the test is. A number of ideas for tests never make it to the clinical trial stage, where the safety and efficacy are evaluated on patient volunteers, and sometimes a promising test that healthcare practitioners read about in the scientific literature never becomes commercially available.

If commercial tests do become available, the laboratory tests must meet stringent standards both during the manufacturing process and when they are used in the clinical laboratory.

 

(1) Simoneau R. Utilizing circulating tumor cells to predict late recurrence. Oncology Times 2018; 40(3): 8,10.