CancerNCT01038024
Study for the Liquid Chromatography-mass Spectrometry (LC-MS/MS) Assessment of Oxidative DNA Damage in Relation to Antioxidant Usage
A study testing 1 tablet composed of antioxidants and minerals in people with Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the basis for the reported good effects of antioxidant supplementation. A blood test using Mass Spectrometry will measure DNA damage which is expected to decrease with antioxidant administration and therefore decrease the risk of cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- 1 tablet composed of antioxidants and minerals
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jul 2012
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Health male or female non-melanoma patients or volunteers
- 18 years or older with a life expectancy greater than 6 months
- Willing to provide pre and post blood samples to measure five DNA modifications in white blood cells
- Willing to participate in a one tablet a day eight week supplement program and to record the ingestion of the supplement on a participant calendar
- Must have never smoked or has not smoked for at least 6 months
- Informed of the investigational nature of the study, is able to provide informed consent and has signed thee informed consent form
Who cannot join
- Patients/healthy volunteers not meeting all of the above selection criteria.
- Patients/healthy volunteers who have a history of kidney stones within the last 5 years.
- Any participant with life threatening conditions including but not limited to cardiac failure, congestive heart failure, unstable coronary artery disease, uncontrolled hypertension, poorly controlled diabetes mellitus, kidney and liver disease,severe metabolic disorders and advanced cancer
- Patients not willing to comply with protocol requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: A Pilot Study for the LC-MS/MS Assessment of Oxidative DNA Damage in Relation to Antioxidant Usage
The purpose of this study is to evaluate the basis for the reported good effects of antioxidant supplementation. A blood test using Mass Spectrometry will measure DNA damage which is expected to decrease with antioxidant administration and therefore decrease the risk of cancer.
Read the detailed description
In this pilot study, the overall purpose is to establish the molecular basis for the hypothesis that oxidative stress is a risk factor for cancer. This will be achieved by establishing base line levels of oxidative DNA damage in a population of healthy individuals before and after taking antioxidant and mineral supplements for 8 weeks.
- Conditions
- Cancer
- Being tested
- 1 tablet composed of antioxidants and minerals
- Keywords
- antioxidant supplement
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 tablet composed of antioxidants and mineralsDietary supplement
1 tablet daily
| Study group | Role | What they receive |
|---|---|---|
| Antioxidant Supplements | Experimental | Not described Receives: Dietary Supplement: 1 tablet composed of antioxidants and minerals |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish a base line level for 5 DNA modifications of White blood cells
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionFeb 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie Zeitouni, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038024
- Sponsor's protocol ID
- I 155409
- Status last verified
- Mar 2013
- First submitted
- 18 Dec 2009
- Last updated
- 8 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for the LC-MS/MS Assessment of Oxidative DNA Damage in Relation to Antioxidant Usage
- ClinicalTrials.gov ID
- NCT01038024
- Acronym / sponsor ID
- I 155409
- Conditions
- Cancer
- Keywords
- antioxidant supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 23 Dec 2009 (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.
The purpose of this study is to evaluate the basis for the reported good effects of antioxidant supplementation. A blood test using Mass Spectrometry will measure DNA damage which is expected to decrease with antioxidant administration and therefore decrease the risk of cancer.
Detailed description
In this pilot study, the overall purpose is to establish the molecular basis for the hypothesis that oxidative stress is a risk factor for cancer. This will be achieved by establishing base line levels of oxidative DNA damage in a population of healthy individuals before and after taking antioxidant and mineral supplements for 8 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antioxidant Supplements | Experimental | Dietary Supplement: 1 tablet composed of antioxidants and minerals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Health male or female non-melanoma patients or volunteers
- 18 years or older with a life expectancy greater than 6 months
- Willing to provide pre and post blood samples to measure five DNA modifications in white blood cells
- Willing to participate in a one tablet a day eight week supplement program and to record the ingestion of the supplement on a participant calendar
- Must have never smoked or has not smoked for at least 6 months
Key exclusion criteria (4 listed)
- Patients/healthy volunteers not meeting all of the above selection criteria.
- Patients/healthy volunteers who have a history of kidney stones within the last 5 years.
- Any participant with life threatening conditions including but not limited to cardiac failure, congestive heart failure, unstable coronary artery disease, uncontrolled hypertension, poorly controlled diabetes mellitus, kidney and liver disease,severe metabolic disorders and advanced cancer
- Patients not willing to comply with protocol requirements
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 |
|---|---|---|
| 1 tablet composed of antioxidants and minerals1 tablet daily | Dietary supplement | Antioxidant Supplements |
Primary outcome
To establish a base line level for 5 DNA modifications of White blood cells
Time frame: 2 years
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 8 Mar 2013.
Related trials for Cancer
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingPhase 1/2
A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
Colorectal Cancer, Pancreatic Ductal Adenocarcinoma
RecruitingPhase 3
A Study of Raludotatug Deruxtecan With or Without Bevacizumab as First-Line Maintenance Treatment in Non-HRD-Positive Advanced Ovarian Cancer (MK-5909-006, (ENGOT-ov102/GOG-3141/ REJOICE-Ovarian 04)
Ovarian Cancer, Ovarian Neoplasms
RecruitingPhase 1/2
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
Lymphoma, Non-Hodgkin Lymphoma
RecruitingPhase 3
Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia
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.
Nathalie Zeitouni, MD principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 tablet composed of antioxidants and minerals in people with Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
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 6 inclusion and 4 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 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
To establish a base line level for 5 DNA modifications of White blood cells (time frame: 2 years). 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 8 Mar 2013.