Clinical trial · Interventional
Treatment of Newly Diagnosed Ovarian Cancer With Antioxidants
Antioxidant Effects on the Outcome of Ovarian Cancer
NCT00228319CI-TRIAL-00033362completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Oral Ascorbic Acid | Dietary Supplement | — | UNRESOLVED |
| Oral Mixed natural Carotenoids with Vitamin A | Dietary Supplement | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Sodium Ascorbate | Drug | — | UNRESOLVED |
| Vitamin E | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care Group
- description
- carboplatin and paclitaxel chemotherapy
- interventionNames
- Drug: Paclitaxel
- Drug: Carboplatin
- type
- EXPERIMENTAL
- label
- Standar of Care + Ascorbic Acid 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.
- interventionNames
- 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
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTMa 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. PMID 24500406