Treatment of Newly Diagnosed Ovarian Cancer With Antioxidants

NCT00228319 | Completed Phase 1 DMC

• 2 other identifiers: 7823G-01-029
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Adverse events by NCI CTC version 3.0

  At each oncology clinic visit

Secondary Outcomes (4)

• 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

Study Arms (2)

Standard of Care Group

ACTIVE COMPARATOR

carboplatin and paclitaxel chemotherapy

Drug: Paclitaxel; Drug: Carboplatin

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.

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

Interventions

Oral Ascorbic Acid DIETARY_SUPPLEMENT

4 grams per day for 12 months

Standar of Care + Ascorbic Acid Group

Paclitaxel DRUG

Six cycles

Also known as: Taxol, Onxal

Standar of Care + Ascorbic Acid Group; Standard of Care Group

Carboplatin DRUG

Six cycles

Also known as: Paraplatin

Standar of Care + Ascorbic Acid Group; Standard of Care Group

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

Also known as: Vitamin C

Standar of Care + Ascorbic Acid Group

Oral Mixed natural Carotenoids with Vitamin A DIETARY_SUPPLEMENT

Capsule containing mixed carotenoids and vitamin A. Participant to take 1 daily for 12 months

Standar of Care + Ascorbic Acid Group

Vitamin E DIETARY_SUPPLEMENT

500 IU per capsule and participant to take 1 capsule daily for 12 months

Standar of Care + Ascorbic Acid Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jeanne Drisko, MD, CNS, FACN: lead
• Cancer Treatment Research Foundation: collaborator
• University of Kansas Medical Center: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related 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.

  PMID: 24500406 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Ascorbic Acid; Paclitaxel; Carboplatin; Vitamin A; Vitamin E

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Coordination Complexes; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Cyclohexenes; Cyclohexanes; Pigments, Biological; Biological Factors; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jeanne A. Drisko, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Integrative Medicine

Study Record Dates

• First Submitted: September 23, 2005
• First Posted: September 28, 2005
• Study Start: October 1, 2002
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: June 19, 2018

Record last verified: 2018-06

Locations

US (1)