Treatment of Newly Diagnosed Ovarian Cancer With Antioxidants

Jeanne Drisko, MD, CNS, FACN

Status and phase: Completed; Phase 2; Phase 1

Conditions: Ovarian Cancer

Treatments: Drug: Sodium Ascorbate; Drug: Paclitaxel; Dietary Supplement: Oral Mixed natural Carotenoids with Vitamin A; Drug: Carboplatin; Dietary Supplement: Oral Ascorbic Acid; Dietary Supplement: Vitamin E

Study type: Interventional

Funder types: Other

Identifiers

NCT00228319

7823

G-01-029

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Standard of Care Group

Active Comparator group

Description:

carboplatin and paclitaxel chemotherapy

Treatment:

Drug: Carboplatin

Drug: Paclitaxel

Standar of Care + Ascorbic Acid Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Oral Mixed natural Carotenoids with Vitamin A

Dietary Supplement: Vitamin E

Drug: Carboplatin

Drug: Paclitaxel

Dietary Supplement: Oral Ascorbic Acid

Drug: Sodium Ascorbate