Safety of Antioxidants During GYN Cancer Care

NCT00284427 | Completed Phase 2 DMC

• 1 other identifier: 10006
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

It is known that people with cancer are using antioxidant vitamins at high rates. It is not known if these vitamins are safe to use during cancer treatment. It is not known if common vitamins and minerals used by many cancer patients will interfere with cancer treatments by reducing the effectiveness of the cancer therapy. Preliminary studies that look at the addition of antioxidants during cancer therapy show us that antioxidants could play a significant role in the management of cancer. Antioxidants are vitamins and other nutrients that help to decrease inflammation in the body by stopping free radicals or oxidants. Common antioxidants include vitamins E, C, and A, beta-carotene, and glutathione. Some doctors who treat cancer are now using antioxidants with chemotherapy while others believe they should not be used with cancer treatment. The purpose of this study is to try and understand if it is safe efficacious to add antioxidant nutritional supplements to traditional chemotherapy and/or radiation therapy during the treatment of cancer.

Conditions

Ovarian Cancer; Cervical Cancer; Uterine Cancer

Outcome Measures

Primary Outcomes (1)

• Laboratory analysis, NCI Common Criteria for Toxicity version 3

  Completion of study

Secondary Outcomes (1)

• Quality of life - FACT-G at

  Baseline, 6 months and Completion of study

Study Arms (1)

1

EXPERIMENTAL

Vitamin C

Drug: vitamin C

Interventions

vitamin C DRUG

IV Vitamin C given 2-3 times a week

Also known as: Ascorbic Acid

1

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically diagnosed adenocarcinoma and/or sarcoma or squamous cell carcinoma of gynecologic origin (uterine, ovary, cervical) that is newly diagnosed or relapsed. Tumors of the ovary are restricted to epithelial origin. There must be evidence for advanced stage neoplasms and/or patients in need of chemotherapy for metastatic disease.
• The patient must screened for eligibility and have care approved by treating oncologist; the oncology care is to be dictated by the oncology team.
• Patients must be of ambulatory status without evidence of active brain metastasis or spinal cord compression.
• ECOG Performance Status 0-2. (Grade 0 = Fully active, able to carry on all pre-disease activities without restriction Grade 1= Restricted in physical strenuous activity but ambulatory and able to carry out work of a light or sedentary nature e.g. light housework, office work Grade 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.
• Laboratory: ANC =1,500/mm3, Hemoglobin \> 8g/dL, platelet = 1000,000/mm3, total bilirubin = 1.5 mg/dL, creatinine =2.0 mg/dL, transaminase (AST/ALT) =2.5X upper limit, urine uric acid \< 1,000mg/d, urine pH \<6, urine oxalate \<60 mg/d.
• Willingness to take oral nutrients and answer FACT-G QOL questionnaires
• Patients who have no language barrier, are cooperative, and can give informed consent before entering the study after being informed of the medications and procedures to be used in this study may participate.

You may not qualify if:

• G-6PD deficient
• Ovarian tumors: sarcomas, germ cell, or any atypical cell line other than epithelial
• History of oxalate renal calculi; urine oxalate level \> 60 mg/d at baseline
• History of bleeding disorder or hemochromatosis
• Patients undergoing radiation therapy
• Patients enrolled in other trials currently or in the preceding 3 months.
• Patients with evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study will not be allowed to participate.
• ECOG Performance Status of 3-4. (Grade 3 = Capable of only limited self care, confined to bed or chair more than 50% of waking hours. Grade 4 = Completely disabled. Cannot carry on any self care. Totally confined to bed or chair.)
• Co-morbid condition that would affect survival: end stage congestive heart failure, unstable angina, myocardial infarction within 6 weeks of study, uncontrolled blood sugars = 300 mg/dL, patients with known chronic active hepatitis or cirrhosis.
• Patients who consume an excess of alcohol or abuse drugs (an excess of alcohol is defined as more than four of any one of the following per day: 30mL distilled spirits, 340mL beer, or 120mL wine) will not be allowed.
• Patients who smoke tobacco products will not be allowed to participate. Of note, patients who continue or begin to smoke are not allowed to continue with the protocol because we are unable to achieve elevation of the plasma vitamin C level to the desired 400 mg/dL. (Unless 400 mg/dL plasma level is achieved, there is no (presumed) chemotherapeutic action of the high-dose intravenous ascorbate). The inability to achieve the desired plasma level of ascorbate is presumably related to increased oxidative stress from the smoking itself. Patients will be clearly made aware of the possibility of coming off of protocol if they smoke. We will monitor cotinine levels (nicotine metabolite) in suspected smokers.
• Patients who are unwilling to take the oral antioxidants will not be allowed to participate.

Sponsors & Collaborators

• Jeanne Drisko, MD, CNS, FACN: lead
• University of Kansas Medical Center: collaborator

MeSH Terms

Conditions

Ovarian Neoplasms; Uterine Cervical Neoplasms; Uterine Neoplasms

Interventions

Ascorbic Acid

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; Uterine Cervical Diseases; Uterine Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Jeanne Drisko, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Integrative Medicine

Study Record Dates

• First Submitted: January 27, 2006
• First Posted: January 31, 2006
• Study Start: September 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: February 10, 2016

Record last verified: 2016-02