Treatment of Newly Diagnosed Ovarian Cancer With Antioxidants

Phase 1

Completed

• Conditions: Ovarian Cancer
• Interventions: 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

• Registration Number: NCT00228319
• Lead Sponsor: Jeanne Drisko, MD, CNS, FACN

Brief 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.

Study Timeline

• Study Start: 2002-10
• Study First Submitted: 2005-09-23
• Study First Submitted QC: 2005-09-27
• Study First Posted: 2005-09-28
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-16
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care Group	Carboplatin	carboplatin and paclitaxel chemotherapy
Standar of Care + Ascorbic Acid Group	Oral Mixed natural Carotenoids with Vitamin A	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.
Standar of Care + Ascorbic Acid Group	Vitamin E	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.
Standar of Care + Ascorbic Acid Group	Oral Ascorbic Acid	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.
Standar of Care + Ascorbic Acid Group	Carboplatin	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.
Standard of Care Group	Paclitaxel	carboplatin and paclitaxel chemotherapy
Standar of Care + Ascorbic Acid Group	Sodium Ascorbate	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.
Standar of Care + Ascorbic Acid Group	Paclitaxel	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.

Primary Outcome Measures

Name	Time	Method
Adverse events by NCI CTC version 3.0	At each oncology clinic visit

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States