Back to resultsTreatment of Newly Diagnosed Ovarian Cancer With Antioxidants
Primary Purpose
Ovarian Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oral Ascorbic Acid
Paclitaxel
Carboplatin
Sodium Ascorbate
Oral Mixed natural Carotenoids with Vitamin A
Vitamin E
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer
Eligibility 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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of Care Group
Standar of Care + Ascorbic Acid Group
Arm Description
carboplatin and paclitaxel chemotherapy
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.
Outcomes
Primary Outcome Measures
Adverse events by NCI CTC version 3.0
Secondary Outcome Measures
Quality of Life Questionnaire
Blood chemistry
CA-125 analysis
complete CBC with differential
Full Information
NCT ID
NCT00228319
First Posted
September 23, 2005
Last Updated
June 16, 2018
Sponsor
Jeanne Drisko, MD, CNS, FACN
Collaborators
Cancer Treatment Research Foundation, University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00228319
Brief Title
Treatment of Newly Diagnosed Ovarian Cancer With Antioxidants
Official Title
Antioxidant Effects on the Outcome of Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeanne Drisko, MD, CNS, FACN
Collaborators
Cancer Treatment Research Foundation, University of Kansas Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care Group
Arm Type
Active Comparator
Arm Description
carboplatin and paclitaxel chemotherapy
Arm Title
Standar of Care + Ascorbic Acid Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral Ascorbic Acid
Intervention Description
4 grams per day for 12 months
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol, Onxal
Intervention Description
Six cycles
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
Six cycles
Intervention Type
Drug
Intervention Name(s)
Sodium Ascorbate
Other Intervention Name(s)
Vitamin C
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral Mixed natural Carotenoids with Vitamin A
Intervention Description
Capsule containing mixed carotenoids and vitamin A. Participant to take 1 daily for 12 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin E
Intervention Description
500 IU per capsule and participant to take 1 capsule daily for 12 months
Primary Outcome Measure Information:
Title
Adverse events by NCI CTC version 3.0
Time Frame
At each oncology clinic visit
Secondary Outcome Measure Information:
Title
Quality of Life Questionnaire
Time Frame
once a month for 6 months and the end of the study
Title
Blood chemistry
Time Frame
At each oncology clinic visit
Title
CA-125 analysis
Time Frame
At each oncology clinic visit
Title
complete CBC with differential
Time Frame
At each oncology clinic visit
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanne A. Drisko, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24500406
Citation
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.
Results Reference
result
Learn more about this trial
Treatment of Newly Diagnosed Ovarian Cancer With Antioxidants
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