Focus of the Study: DNA Damage Due to Medical Diagnostic X-ray Clinical Trial
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
| Verified date | December 2012 |
| Source | University of Zurich |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Swissmedic |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 102 |
| Est. completion date | November 2012 |
| Est. primary completion date | November 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion criteria: - 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 - 30 subjects without radiation exposure - Given written informed consent - Ability to participate in the study Exclusion criteria: - 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 - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | University Hospital Zurich, Division of Nuclear Medicine | Zurich | ZH |
| Lead Sponsor | Collaborator |
|---|---|
| University of Zurich |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure | No |
| Secondary | 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). | Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure | No |
| Secondary | 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). | Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure | No |