Safety of Antioxidants During GYN Cancer Care
It is known that people with cancer are using antioxidant vitamins at high rates. It is not known if these vitamins are safe to use during cancer treatment. It is not known if common vitamins and minerals used by many cancer patients will interfere with cancer treatments by reducing the effectiveness of the cancer therapy. Preliminary studies that look at the addition of antioxidants during cancer therapy show us that antioxidants could play a significant role in the management of cancer.
Antioxidants are vitamins and other nutrients that help to decrease inflammation in the body by stopping free radicals or oxidants. Common antioxidants include vitamins E, C, and A, beta-carotene, and glutathione. Some doctors who treat cancer are now using antioxidants with chemotherapy while others believe they should not be used with cancer treatment.
The purpose of this study is to try and understand if it is safe efficacious to add antioxidant nutritional supplements to traditional chemotherapy and/or radiation therapy during the treatment of cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety of Oral Antioxidants and Intravenous Vitamin C During GYN Cancer Care|
- Laboratory analysis, NCI Common Criteria for Toxicity version 3 [ Time Frame: Completion of study ] [ Designated as safety issue: Yes ]
- Quality of life - FACT-G at [ Time Frame: Baseline, 6 months and Completion of study ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2005|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Drug: vitamin C
IV Vitamin C given 2-3 times a week
Other Name: Ascorbic Acid
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.