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Treatment of Newly Diagnosed Ovarian Cancer With Antioxidants

J

Jeanne Drisko, MD, CNS, FACN

Status and phase

Completed
Phase 2
Phase 1

Conditions

Ovarian Cancer

Treatments

Drug: Sodium Ascorbate
Drug: Paclitaxel
Dietary Supplement: Oral Mixed natural Carotenoids with Vitamin A
Drug: Carboplatin
Dietary Supplement: Oral Ascorbic Acid
Dietary Supplement: Vitamin E

Study type

Interventional

Funder types

Other

Identifiers

NCT00228319
7823
G-01-029

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

27 participants in 2 patient groups

Standard of Care Group
Active Comparator group
Description:
carboplatin and paclitaxel chemotherapy
Treatment:
Drug: Carboplatin
Drug: Paclitaxel
Standar of Care + Ascorbic Acid Group
Experimental group
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.
Treatment:
Dietary Supplement: Oral Mixed natural Carotenoids with Vitamin A
Dietary Supplement: Vitamin E
Drug: Carboplatin
Drug: Paclitaxel
Dietary Supplement: Oral Ascorbic Acid
Drug: Sodium Ascorbate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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