Focus of the Study: DNA Damage Due to Medical Diagnostic X-rayPhase 2NCT01578395
Impact of Antioxidant Agents on the Number of DNA Double-strand Breaks After Radiation-based Cardiac Examinations
A Phase 2 study testing Low-dose radiation exposure, High-dose radiation exposure and No radiation exposure in people with Focus of the Study: DNA Damage Due to Medical Diagnostic X-ray, run by University of Zurich at 1 site in Switzerland.
Trial summary
Trial with medicinal products Recent studies revealed that radiation-based procedures in patients may lead to DNA double-strand breaks in human blood lymphocytes. Additionally, ex vivo studies with human blood lymphocytes have shown a protective effect of antioxidant agents which have been described to decrease the… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus of the Study: DNA Damage Due to Medical Diagnostic X-ray
- What is being tested?
- Low-dose radiation exposure, High-dose radiation exposure and No radiation exposure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2012to Nov 2012
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female
- 18-70 years of age
- European origin
- Non-smoker
- 30 patients with high-dose radiation exposure from a cardiac examination
- 30 patients with low-dose radiation exposure from a cardiac examination
Show all 9Show fewer
- 30 subjects without radiation exposure
- Given written informed consent
- Ability to participate in the study
Who cannot join
- no known intolerance against one of the applied study drugs or against substances used for formulation of one of the study drugs or against other drugs with similar chemical structures as one of the study drugs
- Leukemia
- Lymphoma
- Radio- or chemotherapy
- Severe renal failure (GFR<30 ml/min)
- Positive pregnancy test or lactation
Show all 10Show fewer
- Radiation-based examination within the last 3 days
- Known glucose-6-phosphate-dehydrogenase deficiency
- Known nephrolithiasis (calciumoxalate calculus)
- Intake of barbiturates, tetracyclines, corticosteroids within the last 4 weeks
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Nuclear Medicine
Zurich, Canton of Zurich, 8091
About this study
Official title: Randomized, Double-blinded, Placebo-controlled, Single Center, and Prospective Phase II Clinical Trial to Analyze the Effects of Antioxidant Agents on DNA Double-strand Breaks in Patients After Radiation-based Cardiac Examinations
Trial with medicinal products
Recent studies revealed that radiation-based procedures in patients may lead to DNA double-strand breaks in human blood lymphocytes. Additionally, ex vivo studies with human blood lymphocytes have shown a protective effect of antioxidant agents which have been described to decrease the number of DNA double-strand breaks.
Read more
This study represents a prospective, double-blinded, randomized, single center, and placebo-controlled phase II clinical trial which analyzes the capability of antioxidant agents to decrease the number of DNA double-strand breaks in human blood lymphocytes in patients undergoing radiation-based cardiac examinations (30 patients with high-dose radiation exposure, 30 patients with low-dose radiation exposure, and 30 subjects without radiation exposure).
A protective effect of antioxidant drugs in patients undergoing radiation-based examinations could therefore change patient management and would provide an important clinical impact.
- Being tested
- Low-dose radiation exposure, High-dose radiation exposure, No radiation exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose radiation exposureRadiation
what: Cardiac CT; dosage: approx. 2-3 mSv; frequency: once
High-dose radiation exposureRadiation
what: cardiac catheterization procedures; dosage: approx. 75 mSv; frequency: once
No radiation exposureOther
Subjects not undergoing any radiation exposure
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine | Experimental | This arm consists of 30 patients who will receive 1200mg n-acetylcysteine dissolved in 50ml NaCl 0.9% iv before either low-dose (10 patients) or high-dose (10 patients) radiation exposure, or no radiation exposure (10 patients) Receives: Radiation: Low-dose radiation exposure; Radiation: High-dose radiation exposure; Other: No radiation exposure |
| Ascorbic acid | Experimental | This arm consists of 30 patients who will receive 3000 mg ascorbic acid dissolved in 50 ml NaCl 0.9% iv before either low-dose (10 patients) or high-dose (10 patients) radiation exposure, or no radiation exposure (10 patients) Receives: Radiation: Low-dose radiation exposure; Radiation: High-dose radiation exposure; Other: No radiation exposure |
| Sodium Chloride (NaCl) | Placebo comparator | This arm consists of 30 patients who will receive 50 ml NaCl 0.9% iv before either low-dose (10 patients) or high-dose (10 patients) radiation exposure, or no radiation exposure (10 patients) Receives: Radiation: Low-dose radiation exposure; Radiation: High-dose radiation exposure; Other: No radiation exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of DNA double-strand breaks under influence of antioxidant agents vs. placebo
Potential change (before and after radiation exposure) in the number of DNA double-strand breaks under the influence of n-acetylcystein or ascorbic acid will be measured by qualitative and quantitative immunofluorescence studies (immunofluorescence microscopy and FACS analysis) and will be compared to study patients administered with placebo (using the same quantifiaction tools).
Measured: Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure
Secondary outcomes (2)
Change in the number of DNA double-strand breaks between n-acetylcysteine and ascorbic acid
Potential change (before and after radiation exposure) in the number of DNA double-strand breaks from patients administered with n-acetylcysteine compared to the number of DNA double-strand breaks from patients administered with ascorbic acid. The change in the number of DNA double-strand breaks will be measured by qualitative and quantitative immunofluorescence studies (immunofluorescence microscopy and FACS analysis).
Measured: Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure
Change in the number of DNA double-strand breaks between no, low, and high radiation exposure
Potential change (before and after radiation exposure) in the number of DNA double-strand breaks between the different study interventions (low-dose radiation exposure, high-dose radiation exposure, and no radiation exposure). The change in the number of DNA double-strand breaks will be measured by qualitative and quantitative immunofluorescence studies (immunofluorescence microscopy and FACS analysis).
Measured: Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of the Study: DNA Damage Due to Medical Diagnostic X-rayStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philipp Kaufmann, MD, Principal investigator, University Hospital Zurich, Division of Nuclear Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578395
- Sponsor's protocol ID
- KEK-ZH-NR: 2010-0352
- Status last verified
- Dec 2012
- First submitted
- 12 Apr 2012
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blinded, Placebo-controlled, Single Center, and Prospective Phase II Clinical Trial to Analyze the Effects of Antioxidant Agents on DNA Double-strand Breaks in Patients After Radiation-based Cardiac Examinations
- ClinicalTrials.gov ID
- NCT01578395
- Acronym / sponsor ID
- KEK-ZH-NR: 2010-0352
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 16 Apr 2012 (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.
Trial with medicinal products
Recent studies revealed that radiation-based procedures in patients may lead to DNA double-strand breaks in human blood lymphocytes. Additionally, ex vivo studies with human blood lymphocytes have shown a protective effect of antioxidant agents which have been described to decrease the number of DNA double-strand breaks.
This study represents a prospective, double-blinded, randomized, single center, and placebo-controlled phase II clinical trial which analyzes the capability of antioxidant agents to decrease the number of DNA double-strand breaks in human blood lymphocytes in patients undergoing radiation-based cardiac examinations (30 patients with high-dose radiation exposure, 30 patients with low-dose radiation exposure, and 30 subjects without radiation exposure).
A protective effect of antioxidant drugs in patients undergoing radiation-based examinations could therefore change patient management and would provide an important clinical impact.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine | Experimental | Radiation: Low-dose radiation exposure, Radiation: High-dose radiation exposure, Other: No radiation exposureThis arm consists of 30 patients who will receive 1200mg n-acetylcysteine dissolved in 50ml NaCl 0.9% iv before either low-dose (10 patients) or high-dose (10 patients) radiation exposure, or no radiation exposure (10 patients) |
| Ascorbic acid | Experimental | Radiation: Low-dose radiation exposure, Radiation: High-dose radiation exposure, Other: No radiation exposureThis arm consists of 30 patients who will receive 3000 mg ascorbic acid dissolved in 50 ml NaCl 0.9% iv before either low-dose (10 patients) or high-dose (10 patients) radiation exposure, or no radiation exposure (10 patients) |
| Sodium Chloride (NaCl) | Placebo comparator | Radiation: Low-dose radiation exposure, Radiation: High-dose radiation exposure, Other: No radiation exposureThis arm consists of 30 patients who will receive 50 ml NaCl 0.9% iv before either low-dose (10 patients) or high-dose (10 patients) radiation exposure, or no radiation exposure (10 patients) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or Female
- 18-70 years of age
- European origin
- Non-smoker
- 30 patients with high-dose radiation exposure from a cardiac examination
Key exclusion criteria (10 listed)
- no known intolerance against one of the applied study drugs or against substances used for formulation of one of the study drugs or against other drugs with similar chemical structures as one of the study drugs
- Leukemia
- Lymphoma
- Radio- or chemotherapy
- Severe renal failure (GFR<30 ml/min)
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 |
|---|---|---|
| Low-dose radiation exposurewhat: Cardiac CT; dosage: approx. 2-3 mSv; frequency: once | Radiation | Ascorbic acid, N-acetylcysteine, Sodium Chloride (NaCl) |
| High-dose radiation exposurewhat: cardiac catheterization procedures; dosage: approx. 75 mSv; frequency: once | Radiation | Ascorbic acid, N-acetylcysteine, Sodium Chloride (NaCl) |
| No radiation exposureSubjects not undergoing any radiation exposure | Other | Ascorbic acid, N-acetylcysteine, Sodium Chloride (NaCl) |
Primary outcome
Change in the number of DNA double-strand breaks under influence of antioxidant agents vs. placebo
Time frame: Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure
Potential change (before and after radiation exposure) in the number of DNA double-strand breaks under the influence of n-acetylcystein or ascorbic acid will be measured by qualitative and quantitative immunofluorescence studies (immunofluorescence microscopy and FACS analysis) and will be compared to study patients administered with placebo (using the same quantifiaction tools).
2 secondary outcomes
Change in the number of DNA double-strand breaks between n-acetylcysteine and ascorbic acid
Time frame: Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure
Change in the number of DNA double-strand breaks between no, low, and high radiation exposure
Time frame: Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure
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 6 Dec 2012.
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.
Philipp Kaufmann, MD principal investigator
University Hospital Zurich, Division of Nuclear Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low-dose radiation exposure, High-dose radiation exposure and No radiation exposure in people with Focus of the Study: DNA Damage Due to Medical Diagnostic X-ray, run by University of Zurich at 1 site in Switzerland.
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 9 inclusion and 10 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 6 Dec 2012. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
Change in the number of DNA double-strand breaks under influence of antioxidant agents vs. placebo (time frame: Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure). 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 6 Dec 2012.