Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284427
Status:
COMPLETED
Last Update Posted:
2016-02-10
First Post:
2006-01-27
Brief Title:
Safety of Antioxidants During GYN Cancer Care
Sponsor:
Jeanne Drisko MD CNS FACN
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
Safety of Oral Antioxidants and Intravenous Vitamin C During GYN Cancer Care
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor radiation therapy during the treatment 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 andor radiation therapy during the treatment of cancer
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 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 30 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
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 30 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None