Safety of Antioxidants During GYN Cancer Care
- From: J <studras@xxxxxxxx>
- Date: Fri, 03 Feb 2006 02:36:17 -0500
http://www.clinicaltrials.gov/ct/show/NCT00284427?order=10
Safety of Antioxidants During GYN Cancer Care
This study is currently recruiting patients.
Verified by University of Kansas January 2006
Sponsored by: University of Kansas
Information provided by: University of Kansas
ClinicalTrials.gov Identifier: NCT00284427
Purpose
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.
Condition
Ovarian Cancer
Cervical Cancer
Uterine Cancer
Drug: Intravenous vitamin C (ascorbic acid)
Intervention Phase II
MedlinePlus related topics: Cervical Cancer; Ovarian Cancer; Uterine
Cancer; Uterine Fibroids
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Historical Control, Single Group
Assignment, Safety Study
Official Title: Safety of Oral Antioxidants and Intravenous Vitamin C
During GYN Cancer Care
Further study details as provided by University of Kansas:
Primary Outcomes: Laboratory analysis, NCI Common Criteria for Toxicity
version 3
Secondary Outcomes: Quality of life ? FACT-G at baseline, 6months, and
completion
Expected Total Enrollment: 50
Study start: September 2005; Expected completion: December 2008
Last follow-up: December 2007; Data entry closure: December 2008
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 pilot trial
is a Phase II study designed to assess safety of high-dose antioxidants in
gynecologic malignancies. Secondarily, we will evaluate efficacy of
antioxidant use. These goals will be accomplished by monitoring adverse
events by clinical evaluation, metabolic functions such as but not limited
to tumor markers, blood counts, hepatic, and renal enzymes, and tumor
response rates secondarily. The study will be conducted at the University
of Kansas Medical Center. Oversight partnership is established with the
FDA-CDER, Kansas Masonic Cancer Research Institute, and the University of
Kansas Medical Center ? IRB.
The study is an open label prospective investigational study in 50
gynecologic cancer patients with a Primary Hypothesis: To assess safety of
adding high-dose antioxidants to chemotherapy in the treatment of
gynecologic malignancies (uterine, cervical, or epithelial ovarian).
Qualitative and quantitative toxicities will be assessed by monitoring
clinical status by National Cancer Institute common toxicity criteria
version 3.0, quality of life measures (FACT-G), and evaluating metabolic
functions including but not limited to hepatic and renal function.
Secondary Hypothesis: To assess efficacy by tumor response rates in
patients with gynecologic malignancies treated with antioxidants to
include intravenous and oral ascorbic acid, intravenous glutathione, oral
mixed carotenoids, mixed tocopherols, and vitamin A. Secondary endpoints
will be time to progression and survival.
Patients with newly diagnosed or recurrent gynecologic cancer will be
invited to participate and these subjects will be limited to those who
present with cervical, uterine, or ovarian of epithelial origin. Fifty
patients will be enrolled. The study subjects will be treated with
antioxidants added to their usual oncologic care for 12 months. This
population was chosen because of anecdotal and case report evidence for
benefit when high-dose antioxidants are added to their care.
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 pilot trial is a Phase II study designed to assess safety of
high-dose antioxidants in gynecologic malignancies.
Secondarily, we will evaluate efficacy of antioxidant use.
These goals will be accomplished by monitoring adverse events by clinical
evaluation, metabolic functions such as but not limited to tumor markers,
blood counts, hepatic, and renal enzymes, and tumor response rates
secondarily. The study will be conducted at the University of Kansas
Medical Center. Oversight partnership is established with the FDA-CDER,
Kansas Masonic Cancer Research Institute, and the University of Kansas
Medical Center ? IRB.
The study is an open label prospective investigational study in 50
gynecologic cancer patients with a Primary Hypothesis: To assess safety of
adding high-dose antioxidants to chemotherapy in the treatment of
gynecologic malignancies (uterine, cervical, or epithelial ovarian).
Qualitative and quantitative toxicities will be assessed by monitoring
clinical status by National Cancer Institute common toxicity criteria
version 3.0, quality of life measures (FACT-G), and evaluating metabolic
functions including but not limited to hepatic and renal function.
Secondary Hypothesis: To assess efficacy by tumor response rates in
patients with gynecologic malignancies treated with antioxidants to
include intravenous and oral ascorbic acid, intravenous glutathione, oral
mixed carotenoids, mixed tocopherols, and vitamin A. Secondary endpoints
will be time to progression and survival.
Patients with newly diagnosed or recurrent gynecologic cancer will be
invited to participate and these subjects will be limited to those who
present with cervical, uterine, or ovarian of epithelial origin. Fifty
patients will be enrolled. The study subjects will be treated with
antioxidants added to their usual oncologic care for 12 months. This
population was chosen because of anecdotal and case report evidence for
benefit when high-dose antioxidants are added to their care.
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 pilot trial
is a Phase II study designed to assess safety of high-dose antioxidants in
gynecologic malignancies. Secondarily, we will evaluate efficacy of
antioxidant use. These goals will be accomplished by monitoring adverse
events by clinical evaluation, metabolic functions such as but not limited
to tumor markers, blood counts, hepatic, and renal enzymes, and tumor
response rates secondarily. The study will be conducted at the University
of Kansas Medical Center. Oversight partnership is established with the
FDA-CDER, Kansas Masonic Cancer Research Institute, and the University of
Kansas Medical Center ? IRB.
The study is an open label prospective investigational study in 50
gynecologic cancer patients with a Primary Hypothesis: To assess safety of
adding high-dose antioxidants to chemotherapy in the treatment of
gynecologic malignancies (uterine, cervical, or epithelial ovarian).
Qualitative and quantitative toxicities will be assessed by monitoring
clinical status by National Cancer Institute common toxicity criteria
version 3.0, quality of life measures (FACT-G), and evaluating metabolic
functions including but not limited to hepatic and renal function.
Secondary Hypothesis: To assess efficacy by tumor response rates in
patients with gynecologic malignancies treated with antioxidants to
include intravenous and oral ascorbic acid, intravenous glutathione, oral
mixed carotenoids, mixed tocopherols, and vitamin A. Secondary endpoints
will be time to progression and survival.
Patients with newly diagnosed or recurrent gynecologic cancer will be
invited to participate and these subjects will be limited to those who
present with cervical, uterine, or ovarian of epithelial origin. Fifty
patients will be enrolled. The study subjects will be treated with
antioxidants added to their usual oncologic care for 12 months. This
population was chosen because of anecdotal and case report evidence for
benefit when high-dose antioxidants are added to their care.
It is anticipated that the results of this study will show safety when
antioxidant therapies are added to chemotherapy in the treatment of
gynecologic malignancies. It is unlikely that there will be interference
of the chemotherapy by the antioxidants based on the experience of the
Principal Investigator in a controlled trial and by anecdotal evidence. It
is possible that there may be no benefit when antioxidants are added to
cancer treatment. However, there may be improvements in quality of life
(QOL) and we will be using the FACT-G, a validated QOL instrument to begin
collecting preliminary data. We would like to begin collecting data in
women with gynecologic malignancies who do not qualify for our current
ongoing ovarian cancer trial. Data collected will be used in a future
larger RO1 submission.
Eligibility
Genders Eligible for Study: Female
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
month.
* 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.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00284427
Jeanne Drisko, MD 913-588-6104 jdrisko@xxxxxxxx
Kansas
University of Kansas Medical Center, Kansas City, Kansas, 66160,
United States; Recruiting
Jeanne Drisko, MD 913-588-6104 jdrisko@xxxxxxxx
Study chairs or principal investigators
Jeanne Drisko, MD, Principal Investigator, University of Kansas
More Information
Study ID Numbers: 10006
Last Updated: January 30, 2006
Record first received: January 27, 2006
ClinicalTrials.gov Identifier: NCT00284427
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-02-02
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