Safety of Oral Antioxidants and Intravenous Vitamin C During GYN Cancer Care
It is known that cancer patients use antioxidants at greater rates than their healthy peers
and these patients generally do not tell their physicians. This use has not been adequately
evaluated. 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. The study will be
conducted at the University of Kansas Medical Center. Oversight partnership is established
with the FDA-CDER, Kansas Masonic Cancer Research Institute, and the University of Kansas
Medical Center - IRB.
The study is an open label prospective investigational study in 50 gynecologic cancer
patients with a Primary Hypothesis: To assess safety of adding high-dose antioxidants to
chemotherapy in the treatment of gynecologic malignancies (uterine, cervical, or epithelial
ovarian). Qualitative and quantitative toxicities will be assessed by monitoring clinical
status by National Cancer Institute common toxicity criteria version 3.0, quality of life
measures (FACT-G), and evaluating metabolic functions including but not limited to hepatic
and renal function.
Secondary Hypothesis: To assess efficacy by tumor response rates in patients with
gynecologic malignancies treated with antioxidants to include intravenous and oral ascorbic
acid, intravenous glutathione, oral mixed carotenoids, mixed tocopherols, and vitamin A.
Secondary endpoints will be time to progression and survival.
Patients with newly diagnosed or recurrent gynecologic cancer will be invited to participate
and these subjects will be limited to those who present with cervical, uterine, or ovarian
of epithelial origin. Fifty patients will be enrolled. The study subjects will be treated
with antioxidants added to their usual oncologic care for 12 months. This population was
chosen because of anecdotal and case report evidence for benefit when high-dose antioxidants
are added to their care.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Laboratory analysis, NCI Common Criteria for Toxicity version 3
Completion of study
Jeanne Drisko, MD
University of Kansas
United States: Food and Drug Administration