Clinical Trials

So this is the most important part - it does not matter what happens in the tubes or animals, unless some one tests on a large number of us, the rest of us are not supposed to believe. Here is a list of at least 8 clinical trials recently, there were a few others a few decades ago. As you maybe know Phase I trials are to be designed to identify the non-toxicity of the new drug, while Phase II trials are designed to evaluate the effectiveness of the treatement. I still have to chek what are the PhaseIII trials for.

1. Phase II - (2005/09-2010/12) - (size: 50 - Female only) - (ClinicalTrials.gov: NCT00284427 ) - University of Kansas Medical Center:
This pilot trial is a Phase II study designed to assess safety of high-dose antioxidants in gynecologic malignancies. Secondarily, we will evaluate efficacy of antioxidant use. These goals will be accomplished by monitoring adverse events by clinical evaluation, metabolic functions such as but not limited to tumor markers, blood counts, hepatic, and renal enzymes, and tumor response rates secondarily. "However, things may be about to change. At a meeting of the American College for the Advancement of Medicine (ACAM) in April, 2003, Jeanne A. Drisko, MD, announced just such a clinical trial at her institution, the University of Kansas Medical Center. Luckily, the Cancer Treatment Research Foundation (CTRF) stepped forward to fund the Kansas City clinical trial. A randomized controlled trial, with Dr. Drisko as principal investigator, is now underway at the University of Kansas Medical Center, evaluating the safety and efficacy of antioxidants when added to chemotherapy in newly diagnosed ovarian cancer (Drisko 2003)".http://www.encyclopedia.com/doc/1G1-122581659.html, http://www2.ljworld.com/news/2006/jul/03/vitamin_c_treatment_shows_cancer_promise/
2. Phase I - (2006/08-2009/08) - (size: 18) - (ClinicalTrials.gov: NCT00441207 ) - Cancer Treatment Centers of America - (Robert D. Levin, MD) - "Study of High-Dose Intravenous (IV) Vitamin C Treatment in Patients With Solid Tumors" - More recent double-blind placebo-controlled studies have shown that oral adminstration of vitamin C provides no benefit to cancer patients. Conversely, intravenous vitamin C administration raises plasma concentrations as high as 14 mM/L, and concentrations of 1-5 mM/L have been found to be selectively cytoxic to tumor cells in vitro. Details: http://www.jaoa.org/cgi/reprint/107/6/213.pdf
3. Phase II - (2008/02-2009/02) - (size: 20) - (ClinicalTrials.gov: NCT00626444 ) "Pilot Trial of Intravenous Vitamin C in Refractory Non-Hodgkin Lymphoma (NHL)" - Thomas Jefferson University ( Daniel A. Monti, MD ) Over 10 weeks, the patients will receive 30 infusions, while the scientists watch for tumor shrinkage or other signs that the progression of the immune-system cancer has slowed or stopped. (On FOXNews: "Thomas Jefferson University Hospital and Jefferson's Kimmel Cancer Center, along with the National Institutes of Health, plan to begin enrollment within the next few weeks of 20 non-Hodgkin's lymphoma patients.. will be given varied intravenous doses of vitamin C three times a week during the study, expected to last from 4 to 6 months". http://www.foxnews.com/wires/2008Jan02/0,4670,VitaminCStudy,00.html);
Press release on http://www.jeffersonhospital.org/news/2007/article15617.html (2008/02/01)
4. Phase I - (20??) In Montreal, McGill University oncologist Wilson Miller has $300,000 to find the maximum safe doses for treating various cancers. http://www.fightprostatecancer.org/site/News2?page=NewsArticle&id=6986. Miller - "High-dose vitamin C therapy: Renewed hope or false promise?" (CMAJ -Leading Canada Medical Journal) http://www.cmaj.ca/cgi/reprint/174/7/956.pdf
5. Phase I - (19??) clinical trials at the University of Nebraska medical school hospital. These trials have established the non-toxicity of this treatment for cancer, and Dr Riordan is now proceeding with a Phase II clinical trial, under the auspices of the National Institutes of Health, using therapeutic doses of vitamin C on Renal Adenoma patients. http://www.canceraction.org.gg/inext.htm
6. Study - (2006/03) - (size: 39) - Kwandong University College of Medicine, Korea - Changes of Terminal Cancer Patients' Health-related Quality of Life after High Dose Vitamin C Administration All patients were given an intravenous administration of 10 g vitamin C twice with a 3-day inter-val and an oral intake of 4 g vitamin C daily for a week.
7. Phase II - (2008/03-2008/06) (size: 150) - (ClinicalTrials.gov: NCT00633581 ) - Kwandong University College of Medicine Myungji Hospital (Korea) - "Efficacy of Vitamin C Injection With Fatigue in Workers After Work" - Single intravenous injection of ascorbic acid 10g(20ml) with 100ml of normal saline over 30 minutes.
8. Riordan HD, Casciari JJ, González MJ, Riordan NH, Miranda-Massari JR, Taylor P, Jackson JA (2005). "A pilot clinical study of continuous intravenous ascorbate in terminal cancer patients". P R Health Sci J, 2005 Dec;24(4):269-76. PMID 16570523. (Safety trial).
9. I give high marks to Shawn Rhea for supplying details about a 1971 IAA clinical trial that involved 50 terminally ill cancer patients, and a similar trial in Scotland a few years later. Both studies found that IAA extended the expected life spans of the subjects. (No "false hope" there.). http://www.hsibaltimore.com/ealerts/ea200610/ea20061019a.html

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Intravenous vitamin C for Cancer