A Phase 1/2 interventional study of Oral Ascorbic Acid and Paclitaxel in Ovarian Cancer, sponsored by Jeanne Drisko, MD, CNS, FACN. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-19.
Sponsored by Jeanne Drisko, MD, CNS, FACN · Phase 1/2, Interventional, and Treatment
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.
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 27 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Jeanne Drisko, MD, CNS, FACN is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
carboplatin and paclitaxel chemotherapy
Drug: Paclitaxel · Drug: Carboplatin
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 · Drug: Paclitaxel · Drug: Carboplatin · Drug: Sodium Ascorbate · Dietary Supplement: Oral Mixed natural Carotenoids with Vitamin A · Dietary Supplement: Vitamin E
4 grams per day for 12 months
Six cycles
Also known as: Taxol, Onxal
Six cycles
Also known as: Paraplatin
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
Also known as: Vitamin C
Capsule containing mixed carotenoids and vitamin A. Participant to take 1 daily for 12 months
500 IU per capsule and participant to take 1 capsule daily for 12 months
Adverse events by NCI CTC version 3.0
Time frame: At each oncology clinic visit
Quality of Life Questionnaire
Time frame: once a month for 6 months and the end of the study
Blood chemistry
Time frame: At each oncology clinic visit
CA-125 analysis
Time frame: At each oncology clinic visit
complete CBC with differential
Time frame: At each oncology clinic visit
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Jeanne Drisko, MD, CNS, FACN