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Treatment of Newly Diagnosed Ovarian Cancer With Antioxidants

NCT00228319 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2018-06-19

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Oral Ascorbic Acid

4 grams per day for 12 months

DRUG

Paclitaxel

Six cycles

DRUG

Carboplatin

Six cycles

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

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

Sponsors & Collaborators

  • Cancer Treatment Research Foundation

    collaborator OTHER

  • University of Kansas Medical Center

    collaborator OTHER

  • Jeanne Drisko, MD, CNS, FACN

    lead OTHER

Principal Investigators

  • Jeanne A. Drisko, MD · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00228319 on ClinicalTrials.gov