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| ID | Type | Description | Link |
|---|---|---|---|
| G-01-029 |
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| Name | Class |
|---|---|
| Cancer Treatment Research Foundation | OTHER |
| University of Kansas Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Group | Active Comparator | carboplatin and paclitaxel chemotherapy |
|
| Standar of Care + Ascorbic Acid Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Ascorbic Acid | Dietary Supplement | 4 grams per day for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events by NCI CTC version 3.0 | At each oncology clinic visit |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeanne A. Drisko, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24500406 | Result | 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. |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D014801 | Vitamin A |
| D014810 | Vitamin E |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Paclitaxel | Drug | Six cycles |
|
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| Carboplatin | Drug | Six cycles |
|
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| Sodium Ascorbate | Drug | 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 |
|
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| Oral Mixed natural Carotenoids with Vitamin A | Dietary Supplement | Capsule containing mixed carotenoids and vitamin A. Participant to take 1 daily for 12 months |
|
| Vitamin E | Dietary Supplement | 500 IU per capsule and participant to take 1 capsule daily for 12 months |
|
| At each oncology clinic visit |
| complete CBC with differential | At each oncology clinic visit |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |