Treatment of Newly Diagnosed Ovarian Cancer With Antioxidants

June 16, 2018 updated by: Jeanne Drisko, MD, CNS, FACN

Antioxidant Effects on the Outcome of Ovarian Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care Group
carboplatin and paclitaxel chemotherapy
Drug: Paclitaxel
Six cycles
Other Names:
  • Taxol
  • Onxal
Drug: Carboplatin
Six cycles
Other Names:
  • Paraplatin
Experimental: Standar of Care + Ascorbic Acid Group
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.
Drug: Paclitaxel
Six cycles
Other Names:
  • Taxol
  • Onxal
Drug: Carboplatin
Six cycles
Other Names:
  • Paraplatin
Dietary supplement: Oral Ascorbic Acid
4 grams per day for 12 months
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life Questionnaire
Time Frame: once a month for 6 months and the end of the study
once a month for 6 months and the end of the study
Blood chemistry
Time Frame: At each oncology clinic visit
At each oncology clinic visit
CA-125 analysis
Time Frame: At each oncology clinic visit
At each oncology clinic visit
complete CBC with differential
Time Frame: At each oncology clinic visit
At each oncology clinic visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeanne Drisko, MD, CNS, FACN

Collaborators

University of Kansas Medical Center
Cancer Treatment Research Foundation

Investigators

  • Principal Investigator: Jeanne A. Drisko, MD, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 23, 2005

First Submitted That Met QC Criteria

September 27, 2005

First Posted (Estimate)

September 28, 2005

Study Record Updates

Last Update Posted (Actual)

June 19, 2018

Last Update Submitted That Met QC Criteria

June 16, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7823
  • G-01-029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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