Clinical trial NCT01578395: Impact of Antioxidant Agents on the Number of DNA Double-strand Breaks After Radiation-based Cardiac Examinations
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Focus of the Study: DNA Damage Due to Medical Diagnostic X-ray
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2012-04-16
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the number of DNA double-strand breaks under influence of antioxidant agents vs. placebo
timeFrame: Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure
Secondary outcomes:
measure: Change in the number of DNA double-strand breaks between n-acetylcysteine and ascorbic acid
timeFrame: Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure
measure: Change in the number of DNA double-strand breaks between no, low, and high radiation exposure
timeFrame: Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Nuclear Medicine
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Nuclear Medicine
name: Philipp Kaufmann, MD
role: PRINCIPAL_INVESTIGATOR
References: