Impact of Antioxidant Agents on the Number of DNA Double-strand Breaks After Radiation-based Cardiac Examinations

University of Zurich (UZH)

Status and phase: Completed; Phase 2

Conditions: Focus of the Study: DNA Damage Due to Medical Diagnostic X-ray

Treatments: Radiation: High-dose radiation exposure; Radiation: Low-dose radiation exposure; Other: No radiation exposure

Study type: Interventional

Funder types: Other

Identifiers

NCT01578395

KEK-ZH-NR: 2010-0352

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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102 participants in 3 patient groups, including a placebo group

N-acetylcysteine

Experimental group

Description:

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)

Treatment:

Other: No radiation exposure

Radiation: High-dose radiation exposure

Radiation: Low-dose radiation exposure

Ascorbic acid

Experimental group

Description:

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)

Treatment:

Other: No radiation exposure

Radiation: High-dose radiation exposure

Radiation: Low-dose radiation exposure

Sodium Chloride (NaCl)

Placebo Comparator group

Description:

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)

Treatment:

Other: No radiation exposure

Radiation: High-dose radiation exposure

Radiation: Low-dose radiation exposure