Trial | NCT00228319  Report issue

Title

Treatment of Newly Diagnosed Ovarian Cancer With Antioxidants
Antioxidant Effects on the Outcome of Ovarian Cancer

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    27
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.
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.
Study Started
Oct 31
2002
Primary Completion
Aug 31
2007
Study Completion
Aug 31
2007
Last Update
Jun 19
2018

Dietary Supplement Oral Ascorbic Acid

4 grams per day for 12 months

Drug Paclitaxel

Six cycles

  • Other names: Taxol, Onxal

Drug Carboplatin

Six cycles

  • Other names: Paraplatin

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

  • Other names: Vitamin C

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

Standard of Care Group Active Comparator

carboplatin and paclitaxel chemotherapy

Standar of Care + Ascorbic Acid Group Experimental

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.

Criteria 

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
No Results Posted