Trial record 4 of 9 for:    drisko

Treatment of Newly Diagnosed Ovarian Cancer With Antioxidants

This study has been completed.
Sponsor:
Collaborators:
Cancer Treatment Research Foundation
University of Kansas Medical Center
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: February 9, 2016
Last verified: February 2016
  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 Phase
Ovarian Cancer
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
Phase 1
Phase 2

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 Medical Center:

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: 27
Study Start Date: October 2002
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard of Care Group
carboplatin and paclitaxel chemotherapy
Drug: Paclitaxel
Six cycles
Other Names:
  • Taxol
  • Onxal
Drug: Carboplatin
Six cycles
Other Name: 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.
Dietary Supplement: Oral Ascorbic Acid
4 grams per day for 12 months
Drug: Paclitaxel
Six cycles
Other Names:
  • Taxol
  • Onxal
Drug: Carboplatin
Six cycles
Other Name: Paraplatin
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 Name: 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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
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 Medical Center
Investigators
Principal Investigator: Jeanne A. Drisko, MD University of Kansas Medical Center
  More Information

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: February 9, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Vitamins
Vitamin E
Tocopherols
Tocotrienols
Alpha-Tocopherol
Ascorbic Acid
Vitamin A
Paclitaxel
Retinol palmitate
Albumin-Bound Paclitaxel
Carboplatin
Antioxidants
Carotenoids
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators

ClinicalTrials.gov processed this record on July 28, 2016