Antioxidant Effects on the Outcome of Ovarian Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Adverse events by NCI CTC version 3.0
研究概览
简要总结
The purpose of this study is to try and understand if there is added benefit or increased harm when antioxidant nutritional supplements are added to traditional chemotherapy in the treatment of ovarian cancer.
详细描述
The subjects are randomized to 2 study groups. Group 1 receives standard chemotherapy prescribed by the cancer doctor (carboplatin and paclitaxel)with a possible choice to extend chemotherapy for up to an additional 12 months.
Group 2 receives standard chemotherapy in the same manner as group 1. In addition, they receive 12 months of oral or IV nutritional supplements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed carcinoma of the ovary stage III or IV
- •measurable or assessable disease
- •drug refractory ovarian cancer
- •must be 18 years of age or must have parental consent to enroll in the study
- •must be ambulatory
排除标准
- •evidence of significant psychiatric disorder by history or exam
- •consumption of excess alcohol (more than 4 of any of the following per day: 30 ml distilled spirits, 340 ml beer, or 120 ml wine) or recreational drugs
- •tobacco use
- •prior treatment with an investigational drug, chemo, radiation therapy, or hormonal therapy within the preceeding month
- •pregnancy
研究组 & 干预措施
Standard of Care Group
carboplatin and paclitaxel chemotherapy
干预措施: Paclitaxel (Drug)
Standard of Care Group
carboplatin and paclitaxel chemotherapy
干预措施: Carboplatin (Drug)
Standar of Care + Ascorbic Acid Group
carboplatin and paclitaxel chemotherapy, plus intravenous sodium ascorbate. In addition, participants will take a mix of vitamins including oral ascorbic acid, oral mixed natural carotenoids with vitamin A and oral vitamin E.
干预措施: Oral Ascorbic Acid (Dietary Supplement)
Standar of Care + Ascorbic Acid Group
carboplatin and paclitaxel chemotherapy, plus intravenous sodium ascorbate. In addition, participants will take a mix of vitamins including oral ascorbic acid, oral mixed natural carotenoids with vitamin A and oral vitamin E.
干预措施: Paclitaxel (Drug)
Standar of Care + Ascorbic Acid Group
carboplatin and paclitaxel chemotherapy, plus intravenous sodium ascorbate. In addition, participants will take a mix of vitamins including oral ascorbic acid, oral mixed natural carotenoids with vitamin A and oral vitamin E.
干预措施: Carboplatin (Drug)
Standar of Care + Ascorbic Acid Group
carboplatin and paclitaxel chemotherapy, plus intravenous sodium ascorbate. In addition, participants will take a mix of vitamins including oral ascorbic acid, oral mixed natural carotenoids with vitamin A and oral vitamin E.
干预措施: Sodium Ascorbate (Drug)
Standar of Care + Ascorbic Acid Group
carboplatin and paclitaxel chemotherapy, plus intravenous sodium ascorbate. In addition, participants will take a mix of vitamins including oral ascorbic acid, oral mixed natural carotenoids with vitamin A and oral vitamin E.
干预措施: Oral Mixed natural Carotenoids with Vitamin A (Dietary Supplement)
Standar of Care + Ascorbic Acid Group
carboplatin and paclitaxel chemotherapy, plus intravenous sodium ascorbate. In addition, participants will take a mix of vitamins including oral ascorbic acid, oral mixed natural carotenoids with vitamin A and oral vitamin E.
干预措施: Vitamin E (Dietary Supplement)
结局指标
主要结局
Adverse events by NCI CTC version 3.0
时间窗: At each oncology clinic visit
次要结局
- Quality of Life Questionnaire(once a month for 6 months and the end of the study)
- Blood chemistry(At each oncology clinic visit)
- CA-125 analysis(At each oncology clinic visit)
- complete CBC with differential(At each oncology clinic visit)
研究者
Jeanne Drisko, MD, CNS, FACN
Director Integrative Medicine
University of Kansas Medical Center