Interim Clinical Study results for a supplement for cancer risk reduction

Townsend Letter for Doctors and Patients,  July, 2005  by Steven Evans

• E-mail
• Print
• Link

Background

In 1998, two cancer research colleagues [Jerome B. Block, MD, and Steven Evans, MS] became convinced that the peer-reviewed literature strongly supported the role of various nutraceuticals in cancer risk reduction. (1,2) As a result, they decided to design and initiate a formal Clinical Study to evaluate the effectiveness of selected antioxidants and other evidence-based supplements for cancer risk reduction. During the next two-year period, they assembled an expert group of medical scientists as consultants who were well-acquainted with the science-based literature in combination with their own personal clinical experiences. The goal was to ascertain which supplements appeared to be most efficacious in contributing to cancer risk reduction. There was no preconceived notion of the number of supplements that might qualify nor any concern for their individual costs.

After 18 rounds of personal interactions and discussions, a consensus emerged for a supplement which was now labeled Formula #18. From the consultants' recommendations together with additional extensive literature review undertaken by the two cancer researchers, the final form of the Formula #18 supplement was completed by Evans and Block. Formula #18 contains 14 of the "best of the best" ingredients which have scientific and clinical evidence suggesting an effective role in cancer risk reduction. Table 1 lists its ingredients and quantities of each.

In 2000, the designers embarked upon an empirical Clinical Study to assess this supplement's usefulness for cancer risk reduction. Since controlling patent protection of this supplement was unlikely, conventional pharmaceutical corporations would not likely be interested in such a trial. (3) Consultants suggested a five year Clinical Study with perhaps thousands of participants similar to the design of the NIH SELECT Trial which would be an analogue to this Study (the SELECT trial is assessing two ingredients that also occur in Formula #18, namely selenium and vitamin E). The $180 million budgeted for the SELECT Trial suggested an approximate Study cost of over $200 million for the Formula #18 Study if it completely replicated the SELECT design. Without any external funding, this cost presented a barrier to Study initiation. The designers decided to embark upon the Study themselves, recruiting primarily by word of mouth, and scaling down the Study so that it could be supported by the designers themselves, if need be.

Study Protocol

Informed Consent. A signed Informed Consent is required of all participants in the Study which conforms to traditional informed consent documents used in classical clinical trials and which rigorously articulates that the effectiveness of this supplement remains unverified at the current time. The Informed Consent document required from all participants makes it abundantly clear that they must understand it is not yet known whether this supplement will achieve risk reduction, but it is the purpose of the Study to obtain data to address this question. In unmistakable terms, they are apprised that this composite supplement does not treat, cure, diagnosis, nor is as yet known, to prevent cancer or any disease. Obtaining such data is the point of the Study.

Inclusion and Exclusion Factors. Inclusion and exclusion factors were derived, consistent with conventional clinical trial designs, in which all pertinent, known or suspected disease-state interactions and drug-supplement interactions are listed so that potential participants with any of these conditions (e.g., undergoing radiation or chemotherapy) or on any of the listed drugs (e.g., Mirandon, Coumadin, Dilantin, etc.) are apprised at the onset of their ineligibility. An acknowledgment of the inclusion and exclusion factors must be signed by each participant. In addition, a Cancer Risk Questionnaire itemizing cancer risk factors is provided prior to enrollment, and no participant may join the Study without a minimum number of cancer risk factors as defined by this questionnaire since elevated risk defined by this Questionnaire is a required inclusion factor (otherwise Study participation is not justified).

Ongoing Monitoring. With every bimonthly shipment of the supplement, each participant is required to sign again an acknowledged review of the inclusion and exclusion factors, indicating their ongoing applicability to the participant. Another bi-monthly survey form itemizes potential side effects and reactions, along with open-ended inquiries which participants review, check, and return. Survey form responses are reviewed by the trial supervisor every month for every responding participant and are immediately followed up on a personal basis whenever necessary. An 800 number is provided for questions and information as may be needed by participants.

Health Care Provider Coordination. There is a notice that participants are required to sign prior to enrollment indicating they understand they have been directed and encouraged by the supervisors of this Study to keep all their health care providers aware of their Study participation.