Ovarian CancerPhase 2NCT00284427
Safety of Antioxidants During GYN Cancer Care
A Phase 2 study testing vitamin C in people with Ovarian Cancer and Cervical Cancer, run by Jeanne Drisko, MD, CNS, FACN.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Cancer, Cervical Cancer, Uterine Cancer
- What is being tested?
- vitamin C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Dec 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: Safety of Oral Antioxidants and Intravenous Vitamin C During GYN Cancer Care
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.
Read the 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 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.
- Conditions
- Ovarian Cancer, Cervical Cancer, Uterine Cancer
- Being tested
- vitamin C
- Medical subject headings
- Ovarian Neoplasms, Uterine Cervical Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin CDrug
Also called Ascorbic Acid
IV Vitamin C given 2-3 times a week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Vitamin C Receives: Drug: vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory analysis, NCI Common Criteria for Toxicity version 3
Measured: Completion of study
Secondary outcomes (1)
Quality of life - FACT-G at
Measured: Baseline, 6 months and Completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2006 (estimated)
- Study startSep 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeanne Drisko, MD, CNS, FACN
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas Medical Center
- Responsible party
- Sponsor-investigator, Jeanne Drisko, MD, CNS, FACN, University of Kansas Medical Center
- Investigators
- Jeanne Drisko, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284427
- Sponsor's protocol ID
- 10006
- Status last verified
- Feb 2016
- First submitted
- 27 Jan 2006
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Oral Antioxidants and Intravenous Vitamin C During GYN Cancer Care
- ClinicalTrials.gov ID
- NCT00284427
- Acronym / sponsor ID
- 10006
- Conditions
- Ovarian Cancer, Cervical Cancer, Uterine Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Jeanne Drisko, MD, CNS, FACNUniversity, hospital or other
- Collaborators
- University of Kansas Medical Center
- Study start
- Sep 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 31 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: vitamin CVitamin C |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin CAlso: Ascorbic AcidIV Vitamin C given 2-3 times a week | Drug | 1 |
Primary outcome
Laboratory analysis, NCI Common Criteria for Toxicity version 3
Time frame: Completion of study
1 secondary outcome
Quality of life - FACT-G at
Time frame: Baseline, 6 months and Completion of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne Drisko, MD principal investigator
University of Kansas Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vitamin C in people with Ovarian Cancer and Cervical Cancer, run by Jeanne Drisko, MD, CNS, FACN.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory analysis, NCI Common Criteria for Toxicity version 3 (time frame: Completion of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2016.