It is estimated that greater than 80% of cancer patients use complementary and alternative medicine therapies during their cancer care. This includes antioxidants, which are theorized to impact conventional care. It is our hypothesis that adding antioxidants to chemotherapy can be beneficial in treating malignancies. We report preliminary information on an ongoing trial.
The trial is a randomized prospective study enrolling 40 women with newly diagnosed stage III or IV ovarian cancer receiving either first-line chemotherapy with paclitaxel and carboplatin or first-line chemotherapy combined with high-dose oral and intravenous antioxidants. The study is ongoing with 20 women enrolled to date, 10 in each arm. The study was approved by the University of Kansas Investigational Review Board and conducted under an FDA IND # 65,805. Antioxidants used in the treatment arm include oral mixed natural vitamin E, natural vitamin A, mixed natural carotenoids, and ascorbic acid powder. This is combined with intravenous ascorbic acid to achieve a plasma vitamin C level of 400mg/dL. The average vitamin C infusion for participants in the treatment arm is between 75 and 100g IV-C. This is given two times per week for one year.
No adverse events have been identified related to the antioxidant administration. Adverse events related to chemotherapy are reported at an expected rate and include neutropenia, thrombocytopenia, etc.
1. Preliminary data to date suggests that antioxidants do not inhibit paclitaxel and carboplatin chemotherapy. 2. There is no evidence that antioxidants are unsafe at these levels. 3. We cannot comment on efficacy of treatment at this point because the trial is ongoing. 4. Action of oral and intravenous antioxidants may be different: the oral may have a vitamin-like antioxidant activity; the intravenous therapy may be chemotherapy.