Continuous intravenous vitamin C in the cancer treatment: re-evaluation of a Phase I clinical study

Abstract

Background: Intravenous high-dose vitamin C (IVC) therapy is widely used in naturopathic and integrative oncology. A number of Phase I and Phase II clinical trials were launched to prove the benefits of the IVC therapy. Many case studies demonstrated the effectiveness of IVC, with various degrees of success. Clinical trials using IVC to treat cancer have, to date, demonstrated its safety without conclusively proven its efficacy.  One difficulty in administering IVC is determining the optimal treatment schedule.  To this end, data from a previous Phase 1 clinical trial conducted in 1998 using continuous vitamin C infusions was analyzed to examine the effects of this regimen on key prognostic parameters.  Method: Twenty-four subjects were given continuous IVC at doses between 150 and 710 mg/kg/day. Most of the patients had colon cancer with liver and lung metastasis and three patients had pancreatic or liver cancer. All patients had several chemotherapy/radiation treatments before entering the study. Patients were treated by pharmaceutical grade sodium ascorbate diluted in Lactated Ringers solution with the rate of infusion of 20 ml/hr or 10 ml/hr for lower doses. This diluted solution was administered by continuous infusion.Results: Prior to treatment, serum lymphocyte counts and ascorbate concentrations tended to be low while serum levels of lactate dehydrogenase (LDH), neutrophils, and glucose tended to be high.  Improvements were seen during IVC therapy.  In patients with initially elevated neutrophil levels, numbers tended to decrease.  In contrast, increased absolute neutrophil and lymphocyte numbers were seen in patients with initially low counts.  Neutrophil to lymphocyte ratios (NLR) proved to be a good indicator of cancer patients’ survival times (high NLR, low survival).   This was also true of LDH, creatinine, and glucose concentrations.   In patients with the highest pre-treatment NLR, rate of growth of this ratio decreased significantly during therapy.  IVC treatments were also associated with decreases in glucose concentrations, restoration of vitamin C levels, and, in about 40% of cases, reductions in LDH levels. Conclusions: As the result of the study we found that continuous IVC infusions improved several parameters associated with poor cancer prognosis. The data suggests a strategic benefit to using lower IVC doses in continuous infusions: raising the dose above 300 mg/kg/day (20 grams in 70 kg human) increased the frequency of side effects without noticeably increasing plasma ascorbate levels.  Moreover, improvements in lymphocyte counts at low IVC doses tended to decrease at the higher doses.  In conclusion, continuous infusions had benefits to cancer patients and further research in this area is warranted.Keywords: ascorbic acid; continuous infusion; cancer patients; clinical trial; lymphopenia; neutrophil to lymphocyte ratio; hyperglycemia; safety.