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Treatment of Newly Diagnosed Ovarian Cancer With Antioxidants

This study has been completed.
Sponsor:
Collaborators:
Cancer Treatment Research Foundation
University of Kansas
Information provided by (Responsible Party):
Jeanne Drisko, MD, CNS, FACN, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00228319
First received: September 23, 2005
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Ovarian Cancer
Drug: oral & IV antioxidant vitamins and minerals, chemotherapy
Drug: paclitaxel and carboplatin chemotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antioxidant Effects on the Outcome of Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Adverse events by NCI CTC version 3.0 [ Time Frame: At each oncology clinic visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of Life Questionnaire [ Time Frame: once a month for 6 months and the end of the study ] [ Designated as safety issue: No ]
  • Blood chemistry [ Time Frame: At each oncology clinic visit ] [ Designated as safety issue: Yes ]
  • CA-125 analysis [ Time Frame: At each oncology clinic visit ] [ Designated as safety issue: No ]
  • complete CBC with differential [ Time Frame: At each oncology clinic visit ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: October 2002
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
carboplatin and paclitaxel chemotherapy
Drug: paclitaxel and carboplatin chemotherapy
paclitaxel and carboplatin chemotherapy
Experimental: 2
carboplatin and paclitaxel chemotherapy, antioxidant vitamins and minerals
Drug: oral & IV antioxidant vitamins and minerals, chemotherapy
carboplatin, paclitaxel chemotherapy, oral and IV antioxidant vitamins and minerals

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228319

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Jeanne Drisko, MD, CNS, FACN
Cancer Treatment Research Foundation
University of Kansas
Investigators
Principal Investigator: Jeanne A. Drisko, MD University of Kansas
  More Information

No publications provided

Responsible Party: Jeanne Drisko, MD, CNS, FACN, Director Integrative Medicine, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00228319     History of Changes
Other Study ID Numbers: 7823, G-01-029
Study First Received: September 23, 2005
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Antioxidants
Carboplatin
Paclitaxel
Vitamins
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Growth Substances
Micronutrients
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014