Treatment of Newly Diagnosed Ovarian Cancer With Antioxidants
| Status: | Completed |
|---|---|
| Conditions: | Ovarian Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/21/2018 |
| Start Date: | October 2002 |
| End Date: | August 2007 |
Antioxidant Effects on the Outcome of Ovarian Cancer
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.
harm when antioxidant nutritional supplements are added to traditional chemotherapy in the
treatment of ovarian cancer.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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