Status:
COMPLETED
Safety of Antioxidants During GYN Cancer Care
Lead Sponsor:
Jeanne Drisko, MD, CNS, FACN
Collaborating Sponsors:
University of Kansas Medical Center
Conditions:
Ovarian Cancer
Cervical Cancer
Eligibility:
FEMALE
Phase:
PHASE2
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 mine...
Detailed Description
It is known that cancer patients use antioxidants at greater rates than their healthy peers and these patients generally do not tell their physicians. This use has not been adequately evaluated. This ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00284427
Start Date
September 1 2005
End Date
December 1 2006
Last Update
February 10 2016
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