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OpenTrials
Completed

NCT Number: NCT00228319

Treatment of Newly Diagnosed Ovarian Cancer With Antioxidants

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Ascorbic Acid

Dietary Supplement

4 grams per day for 12 months

paclitaxel

Drug

Six cycles

Other names: Taxol, Onxal

carboplatin

Drug

Six cycles

Other names: Paraplatin

Sodium Ascorbate

Drug

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

Oral Mixed natural Carotenoids with Vitamin A

Dietary Supplement

Capsule containing mixed carotenoids and vitamin A. Participant to take 1 daily for 12 months

Vitamin E

Dietary Supplement

500 IU per capsule and participant to take 1 capsule daily for 12 months

Primary outcomes

  1. Adverse events by NCI CTC version 3.0

    Time frame: At each oncology clinic visit

Secondary outcomes

  1. Quality of Life Questionnaire

    Time frame: once a month for 6 months and the end of the study

  2. Blood chemistry

    Time frame: At each oncology clinic visit

  3. CA-125 analysis

    Time frame: At each oncology clinic visit

  4. complete CBC with differential

    Time frame: At each oncology clinic visit

Sponsors and collaborators

Lead sponsor

Jeanne Drisko, MD, CNS, FACN

Other

Collaborators

  • Cancer Treatment Research Foundation
  • University of Kansas Medical Center

Registry information

Official study title

Antioxidant Effects on the Outcome of Ovarian Cancer

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Sep 28, 2005
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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