Pulse-Press-Rest IVC Study

A NEW CANCER RESEARCH INITIATIVE AT RIORDAN CLINIC

 

The following is an open call for research subjects to participate in a clinical study of the safety and plausibility of two potential updates to the Riordan IVC Protocol for Adjunctive Cancer Care.

Authors: Ron Hunninghake, MD • Nina Mikirova, PhD • Lucas Tims, ND, FABNO

Cancer Care Reimagined

In 1975, Dr. Hugh Riordan and Mrs. Olive W. Garvey teamed up to open The Center for the Improvement of Human Functioning, now known as the Riordan Clinic. Because Dr. Riordan was a psychiatrist, most of the initial research was done in the pursuit of a bionutritional approach to mental illness.

It wasn’t long, however, before Dr. Riordan realized that this innovative approach could be used to treat many chronic illnesses such as heart disease, chronic fatigue syndrome, obesity, diabetes, fibromyalgia, autoimmune disease, and other systemic illnesses…including cancer. Early on, Dr. Riordan made use of larger than RDA doses of vitamins and minerals, based upon deficiencies defined by laboratory testing at the Clinic’s Bio-Center Lab – a CLIA tested and approved facility.

One nutrient deficiency stood out above all the rest: vitamin C! Riordan was quick to observe that almost every advanced cancer patient he treated had extremely low levels of serum vitamin C. Simply put, cancer patients typically suffered from SCURVY!

It was little wonder that breakthrough vitamin C research at The Vale of Leven Hospital in Scotland in the 1970s captivated Riordan’s attention. Could higher doses of vitamin C, given intravenously, have a greater impact in the adjunctive care of cancer patients?

Vitamin C and Cancer Research

Vitamin C research has always been fraught with controversy.

It is fitting to republish here a salient quotation of Scottish physician Ewan Cameron, who along with the famous researcher Dr. Linus Pauling, launched the original research in the use of intravenous vitamin C (IVC) in the care of cancer patients.

“Today I propose to tell you of my personal involvement in this still highly controversial subject,
the vitamin C in cancer story. The matter is capable of arousing almost any emotion from bitter
prejudice and blazing anger on the one hand, to unbridled (and undeserved) enthusiasm on the
other, with all grades of scorn, laughter, ridicule, and pity in between. I hope to convince you
that the whole research project has a perfectly sound scientific basis and that Dr. Pauling and
I are neither gullible fools, nor are
we charlatans.”
Ewan Cameron, “Vitamin C and Cancer: A Personal Perspective” September 1984

By 1986 Cameron and Pauling and a research group in Japan had treated more than one thousand cancer patients with supplemental vitamin C. Their consensus conclusion was that vitamin C, given in pharmacologic doses (10 grams or more,) enhanced innate and cell-mediated immunity, while providing a selective cytotoxic effect on malignant cells, yet harmless to normal cells.

These and other benefits of high dose vitamin C greatly improved the quality of life of advanced cancer patients. More striking was the four-fold increase in life extension compared to carefully matched controls. In 10% of cases, the life-extension was up to ten-fold!

The Mayo Clinic Debacle

Sadly, two Mayo Clinic “replications” neglected to scientifically reproduce the key elements of the above-mentioned studies:

  1. The high dose vitamin C was NOT given by intravenous infusion.
  2. The oral dosing of vitamin C was given as large doses of capsules – sure to cause GI distress. Pauling and Cameron gave their 10-gram oral follow-up program as a buffered liquid that was taken before each meal and at bedtime as a 2.5 gram, easy-on-the-gut, dosing regimen.

The Mayo studies showed no difference between control and treated cases. Rather than demanding an appropriate replication study to reassess the Cameron-Pauling findings, conventional oncologists based their now well-established bias against IVC on Mayo’s reputation alone. For four decades, with notable exceptions, the majority of oncologists abandoned IVC as a safe adjunct in the care of cancer patients.

RECNAC: Nontoxic, Adjunctive Cancer Care

Since the early 1990s, the Riordan Clinic in Wichita, KS has been home to novel anticancer research. When the clinic’s founder, Dr. Hugh Riordan was awarded a generous $1,000,000 research grant to find a non-toxic way to control cancer, he boldly launched RECNAC:

Research Encompassing Comprehensive Novel Approaches to Cancer.

Riordan assembled a talented team of dedicated cancer researcher’s intent on discovering the underlying biological causes of cancer. The goal of RECNAC, like its spelling, was to reverse the evergrowing trends of CANCER by identifying nontoxic adjunctive treatment modalities in the care of cancer patients. In 2020 alone, 1.8 million new cases of cancer will be diagnosed.

Just prior to launching RECNAC, a 70-year old patient suffering from renal cell carcinoma, that had already metastasized to his liver and lungs, came to the clinic requesting help. Riordan had turned to high dose intravenous vitamin C – more simply known as IVC – to help the man. Riordan initiated a 30-gram, intermittent IVC plan twice a week for his patient.

Fifteen months later, the patient’s oncologist reported that the metastases in his lungs were gone. The patient remained cancer-free for the next 14 years until congestive heart failure took his life. This result confirmed Riordan’s resolve to initiate RECNAC 1.0, launched in 1990.

For the next 10 years, Dr. Riordan and his Wichita-based RECNAC team went on to make many impressive discoveries regarding the use of intermittent, high-dose IVC. Later they were joined with a group of cancer researchers in Puerto Rico, a RECNAC 2.0 team. In total, and with the tremendous expertise of our current RECNAC Director, Dr. Nina Mikirova, over 38 RECNAC based studies have been published and are available for review at our Riordan Clinic website.

These studies provided the backbone for the development of “The Riordan IVC Protocol for Adjunctive Cancer Care“ as it is currently used by thousands of doctors around the world. The majority of the RECNAC research has been based on the use of intermittent, high-dose IVC, typically a 25 or 50-gram dose of sodium ascorbate is added to either 250 or 500 cc of sterile water, which is then rapidly infused over 60-90 minutes in a peripheral vein.

Download the current IVC Protocol from our website in English, Spanish, and Japanese riordanclinic.org/IVCprotocol

Unexpected, Unpublished Nebraska Findings

One of Dr. Riordan’s early studies was conducted at a University of Nebraska hospital using the Pauling-Cameron method of low-dose, continuous IVC infusions (10 gram over 24 hours for 10 consecutive days). The results were published as a Phase 1 trial demonstrating the safety of low-dose, continuous IVC in the Puerto Rican Medical Journal.

Recently, additional data stemming from that early IVC study was uncovered and analyzed by Dr. Mikirova. Surprisingly, continuous infusion of vitamin C produced several additional improvements in cancer patients: improvements in innate immunity; reductions in serum glucose and insulin resistance; normalization of serum LDH levels (all suggestive of positive metabolic and biological trends.)

These findings led to an aha moment here at Riordan Clinic! Had we overlooked the obvious? After all, Pauling and Cameron had gotten outstanding results with their continuous IVC infusions. Why had Dr. Riordan abandoned that approach in favor of twice a week high-dose IVC?

The answer is simple: the early continuous IVC research was all done in inpatient hospital settings where the hanging IVs could be monitored by the nursing staff day and night. Doing a short term high-dose IVC outpatient twice a week was much more practical. Besides, the high doses achieved what the RECNAC team called “selective cytotoxicity” against almost all tumor types grown on cell culture.

But… how could our nursing staff replicate inpatient continuous IVC on an outpatient basis?

The Birth of an Outpatient Pulse-Press-Rest© Continuous IVC Protocol

Schedule-dependent IV protocols done on an outpatient basis are not uncommon in conventional oncology. The answer is to use what is called an elastomeric pump – sometimes referred to as a “balloon pump.” The pump “pushes” out the treatment fluid at a constant rate of 5 cc’s an hour. Thus, the concentration of the vitamin C fluid is adjusted so that the patient receives 500 mg of continuous IVC while remaining free to move about with the small, light pump tucked away in a fanny pack.

With this capability, it soon became apparent that we could now FUSE the two forms of IVC – Intermittent high-dose bolus IVC followed by continuous mid-dose IVC:

  1. The patient could arrive in the early morning, have their IV started, and then receive what we are now calling a “PULSE” or bolus of high-dose IVC during the first hour or so…
  2. …followed by the attachment of the balloon pump with the mid-dose of vitamin C, which would run at 5 cc’s an hour for about 8 hours in order to maintain the “PRESS” of continuous IVC, similar to what Pauling and Cameron had achieved in their research at Vale of Leven Hospital and what Dr. Riordan had done at the University of Nebraska.
  3. At the conclusion of the day, the nurse can detach the pump and either discontinue the IV catheter or flush and lock it overnight, for repeat use the next day if the site remained uninflamed. We believe this overnight period is an important opportunity for the body physiology to “REST” and better assimilate the redox benefits of both forms of IVC.

This “PULSE-PRESS-REST” cycle will be repeated daily, Monday through Friday during clinic hours. Then after a two-day weekend REST, the whole weekly cycle will be repeated during week 2. (Note: presumably, this strategy could be repeated for as many weeks as is called for, in cases where the patient is facing a more advanced cancer situation, though this is not the intent of the present study.)

Can the Riordan IVC Protocol be Safely Improved with the Pulse-Press-Rest Protocol?

The Riordan IVC Protocol for Adjunctive Cancer Care has been in use around the world now for over 20 years. Thousands of patients and their doctors have relied on its efficacy. The essence of this original version is the intermittent, high-dose IVC given twice a week.

With the new findings of the Nebraska data, it is now apparent that the Riordan IVC Protocol needs an upgrade. Before we can officially release this potential upgrade, it is imperative that the safety and relative efficacy of this protocol be subjected to what is called a Phase 1 clinical trial.

Diagnosed cancer patients can apply for acceptance into the study as of now. APPLY TO BE IN THE STUDY.

Subjects will be required to stay in either Wichita or Overland Park (in the Kansas City metro area) for the entire two weeks to complete TWO 5-day infusion cycles (Monday – Friday) as listed in the write-up above. Baseline lab at the beginning of this 2-week period will include the very thorough Real Health Discovery Lab Panel consisting of over 100 individual nutrient, hormonal, and biochemical measurements. At the end of the first and second week, each participant will be tested for a “Nebraska biomarkers” profile consisting of: a) neutrophil/lymphocyte ratio; b) LDH; c) glucose and Hba1c; d) Lipid Panel and e) CRP. This profile will also be repeated at the end of each month for the full 3-month follow-up plan.

After returning home, participants will receive a monthly call from a Riordan Clinic staff member to fill out a Quality of Life questionnaire, to assure that their Nebraska biomarkers lab panel has been drawn, and to note any new information regarding their overall cancer status. There will be a follow-up appointment or phone call with the doctor to review lab results, approximately two to three weeks after the initial labs are drawn.

Those participants using the Wichita campus will have an additional benefit of a unique educational program entitled “Anticancer Living Insights” which will focus on epigenetic lifestyle choices that have been demonstrated to favor better cancer outcomes.

Because of the difficulty in finding IVC research donors at this time, this RECNAC 3.0 program is to be “self-pay” funded. Research applicants must apply for and be accepted into the “Adjunctive Cancer Care” 2-week plan at Riordan Clinic to qualify for the research. The 3-months follow up testing and tracking program has been funded and will not be the participant’s financial responsibility. Full details of these costs will be available soon.

.“IVC Synergy” – a Second Novel Modification of the Riordan IVC Protocol

Dr. Hugh Riordan often remarked that cancer was best approached on multiple fronts. Over the millennia, herbal medicine has been a traditional source of powerful phytonutrient chemicals with strong healing properties. Indeed, a color-rich diet full of polyphenols, cannabinoids, flavonoids, polyenes, carotenoids, terpenes, cynogenics, and alkaloids…just to name a few…is a scientifically respectable way to both enhance cancer prevention and to augment the treatment of cancer patients.

Hyatt Life Sciences, another Kansas-grown research organization, has devoted 13 years of intense research to demonstrate the powerful healing properties of Afaya Plus, a palette of phytonutrients that features a traditional healing herb from Palestine. Their website – hyattlifesciences.com – robustly documents their commitment to a thorough scientific investigation of these properties.

Afaya Plus is a scientifically researched blend of botanicals paired with vitamin C. Hyatt Life Sciences’ published research shows how Arum Palaestinum and Afaya Plus affect many of the various cell signaling pathways and cellular functions mutated by cancer. By affecting mutated pathways selectively, Hyatt Life Sciences has created a powerful nutraceutical for health.

Not long ago their scientists approached Riordan Clinic with a ground-breaking possibility: could the benefits of the Riordan IVC Protocol be further multiplied with this powerful synergistic herbal complex?

A Second Arm of the RECNAC 3.0 Research

The scientific question our researchers faced was this: How can we efficiently assess the safety of the Pulse-Press-Rest IVC Protocol and reaffirm its potential benefits… AND simultaneously evaluate the potential synergy of Afaya Plus without confusing the individual integrity of the two novel modifications?

Lucas Tims, ND, FABNO, Riordan Clinic’s Naturopathic Oncologist, had this breakthrough idea: all 40 of the subjects will undergo the same Pulse-Press-Rest IVC Protocol for the first two weeks of the research. The 3-month follow-up plan (as is suggested in the Riordan IVC Protocol – namely outpatient IVC twice a week) will remain the same for the 40 subjects with one exception: 20 of the subjects will be randomized to receive the Afaya Plus for the entire 3 month period. This will provide the study with a “matched cohort.”

We believe that this Phase 1 study will accomplish three goals:

  1. Demonstration of the safety of the Pulse-Press-Rest IVC Protocol
  2. Provisional confirmation of the improvement of “the Nebraska biomarkers” (as outlined on page 6)
  3. Assessment of safety, palatability and synergy of the Afaya Plus capsules with the 3 months of twice-weekly
    IVC in the follow-up of the new Pulse-Press-Rest

The cost of the Afaya Plus herbal capsules and the 5 sets of “Nebraska biomarkers” for each participant will be covered by two generous research donors. The other component costs, as outlined on our website, will remain the responsibility of each self-pay participant.

APPLY TO BE IN THE STUDY

 

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