Treatment of Newly Diagnosed Ovarian Cancer With Antioxidants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Antioxidant Effects on the Outcome of Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Dietary Supplement: Oral Ascorbic Acid
* Drug: Paclitaxel
* Drug: Carboplatin
* Drug: Sodium Ascorbate
* Dietary Supplement: Oral Mixed natural Carotenoids with Vitamin A
* Dietary Supplement: Vitamin E


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care Group<br>carboplatin and paclitaxel chemotherapy | Drug: Paclitaxel<br>* Six cycles<br>* Other names: Onxal;Drug: Carboplatin<br>* Six cycles<br>* Other names: Paraplatin;|
| Experimental: Standar of Care + Ascorbic Acid Group<br>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. | Dietary Supplement: Oral Ascorbic Acid<br>* 4 grams per day for 12 months<br>Drug: Paclitaxel<br>* Six cycles<br>* Other names: Onxal;Drug: Carboplatin<br>* Six cycles<br>* Other names: Paraplatin;Drug: Sodium Ascorbate<br>* 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<br>* Other names: Vitamin C;Dietary Supplement: Oral Mixed natural Carotenoids with Vitamin A<br>* Capsule containing mixed carotenoids and vitamin A. Participant to take 1 daily for 12 months<br>Dietary Supplement: Vitamin E<br>* 500 IU per capsule and participant to take 1 capsule daily for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events by NCI CTC version 3.0 |  | At each oncology clinic visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |