Treatment of Newly Diagnosed Ovarian Cancer With Antioxidants
NCT ID: NCT00228319
Last Updated: 2018-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
27 participants
INTERVENTIONAL
2002-10-31
2007-08-31
Brief Summary
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Detailed Description
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Group 2 receives standard chemotherapy in the same manner as group 1. In addition, they receive 12 months of oral or IV nutritional supplements.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of Care Group
carboplatin and paclitaxel chemotherapy
Paclitaxel
Six cycles
Carboplatin
Six cycles
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.
Oral Ascorbic Acid
4 grams per day for 12 months
Paclitaxel
Six cycles
Carboplatin
Six cycles
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
Oral Mixed natural Carotenoids with Vitamin A
Capsule containing mixed carotenoids and vitamin A. Participant to take 1 daily for 12 months
Vitamin E
500 IU per capsule and participant to take 1 capsule daily for 12 months
Interventions
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Oral Ascorbic Acid
4 grams per day for 12 months
Paclitaxel
Six cycles
Carboplatin
Six cycles
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
Oral Mixed natural Carotenoids with Vitamin A
Capsule containing mixed carotenoids and vitamin A. Participant to take 1 daily for 12 months
Vitamin E
500 IU per capsule and participant to take 1 capsule daily for 12 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Cancer Treatment Research Foundation
OTHER
University of Kansas Medical Center
OTHER
Jeanne Drisko, MD, CNS, FACN
OTHER
Responsible Party
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Jeanne Drisko, MD, CNS, FACN
Director Integrative Medicine
Principal Investigators
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Jeanne A. Drisko, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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References
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Ma Y, Chapman J, Levine M, Polireddy K, Drisko J, Chen Q. High-dose parenteral ascorbate enhanced chemosensitivity of ovarian cancer and reduced toxicity of chemotherapy. Sci Transl Med. 2014 Feb 5;6(222):222ra18. doi: 10.1126/scitranslmed.3007154.
Other Identifiers
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G-01-029
Identifier Type: -
Identifier Source: secondary_id
7823
Identifier Type: -
Identifier Source: org_study_id
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