Ovarian Cancer
Conditions
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.
Interventions
DIETARY_SUPPLEMENTOral Ascorbic Acid
4 grams per day for 12 months
DRUGPaclitaxel
Six cycles
DRUGCarboplatin
Six cycles
DRUGSodium 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
DIETARY_SUPPLEMENTOral Mixed natural Carotenoids with Vitamin A
Capsule containing mixed carotenoids and vitamin A. Participant to take 1 daily for 12 months
DIETARY_SUPPLEMENTVitamin E
500 IU per capsule and participant to take 1 capsule daily for 12 months
Sponsors
Cancer Treatment Research Foundation
University of Kansas Medical Center
Jeanne Drisko, MD, CNS, FACN
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events by NCI CTC version 3.0 | At each oncology clinic visit |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life Questionnaire | once a month for 6 months and the end of the study |
| Blood chemistry | At each oncology clinic visit |
| CA-125 analysis | At each oncology clinic visit |
| complete CBC with differential | At each oncology clinic visit |
Countries
United States
Outcome results
None listed