NCT00228319

Treatment of Newly Diagnosed Ovarian Cancer With Antioxidants

Antioxidant Effects on the Outcome of Ovarian Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Jeanne Drisko, MD, CNS, FACN · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Oral Ascorbic Acid	4 grams per day for 12 months
DRUG	Paclitaxel	Six cycles
DRUG	Carboplatin	Six cycles
DRUG	Sodium Ascorbate	Intravenous infusion at 0.5 gram/min twice weekly over 1-2 hours at a dose to achieve levels of 400 mg/dl for 12 months
DIETARY_SUPPLEMENT	Oral Mixed natural Carotenoids with Vitamin A	Capsule containing mixed carotenoids and vitamin A. Participant to take 1 daily for 12 months
DIETARY_SUPPLEMENT	Vitamin E	500 IU per capsule and participant to take 1 capsule daily for 12 months

Timeline

• Start date: 2002-10-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2005-09-28
• Last updated: 2018-06-19

Locations

1 site across 1 country: United States