Treatment of Newly Diagnosed Ovarian Cancer With Antioxidants

Ovarian Cancer Clinical Trial

Official title:

Antioxidant Effects on the Outcome of Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00228319
• Other study ID #: 7823
• Secondary ID: G-01-029
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 2002
• Est. completion date: August 2007

Study information

• Verified date: June 2018
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Dietary Supplement:
• Oral Ascorbic Acid
4 grams per day for 12 months

Drug:
• 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

Dietary Supplement:
• 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

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
Jeanne Drisko, MD, CNS, FACN	Cancer Treatment Research Foundation, University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events by NCI CTC version 3.0		At each oncology clinic visit
Secondary	Quality of Life Questionnaire		once a month for 6 months and the end of the study
Secondary	Blood chemistry		At each oncology clinic visit
Secondary	CA-125 analysis		At each oncology clinic visit
Secondary	complete CBC with differential		At each oncology clinic visit