Impact of Antioxidant Agents on the Number of DNA Double-strand Breaks After Radiation-based Cardiac Examinations
December 5, 2012 updated by: University of Zurich
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.
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
ZH
-
Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Division of Nuclear Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: N-acetylcysteine
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)
|
what: Cardiac CT; dosage: approx.
2-3 mSv; frequency: once
what: cardiac catheterization procedures; dosage: approx.
75 mSv; frequency: once
Subjects not undergoing any radiation exposure
|
|
EXPERIMENTAL: Ascorbic acid
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)
|
what: Cardiac CT; dosage: approx.
2-3 mSv; frequency: once
what: cardiac catheterization procedures; dosage: approx.
75 mSv; frequency: once
Subjects not undergoing any radiation exposure
|
|
PLACEBO_COMPARATOR: Sodium Chloride (NaCl)
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)
|
what: Cardiac CT; dosage: approx.
2-3 mSv; frequency: once
what: cardiac catheterization procedures; dosage: approx.
75 mSv; frequency: once
Subjects not undergoing any radiation exposure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
|
|
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Philipp Kaufmann, MD, University Hospital Zurich, Division of Nuclear Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (ACTUAL)
November 1, 2012
Study Completion (ACTUAL)
November 1, 2012
Study Registration Dates
First Submitted
April 12, 2012
First Submitted That Met QC Criteria
April 13, 2012
First Posted (ESTIMATE)
April 16, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
December 6, 2012
Last Update Submitted That Met QC Criteria
December 5, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- KEK-ZH-NR: 2010-0352
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