Nitroglycerin for Intra-arterial Chemotherapy in Pediatric Retinoblastoma.

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Sep 21, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called nitroglycerin on children with retinoblastoma, a type of eye cancer. When these children receive intra-arterial chemotherapy (a targeted treatment delivered directly to the eye's blood vessels), some may experience side effects related to their heart and breathing. The trial aims to see if giving nitroglycerin before the chemotherapy can help reduce these side effects by relaxing the blood vessels in the eye and making the procedure safer.

To participate in this study, children must be diagnosed with retinoblastoma and require intra-arterial chemotherapy while under general anesthesia. However, children with certain health conditions, such as serious lung issues or unstable vital signs, cannot participate. During the trial, eligible participants will randomly receive either nitroglycerin or a saltwater solution (placebo) before their treatment. This study is currently recruiting participants, and it is important for families to discuss any questions or concerns with their healthcare team.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Retinoblastoma patients who need intra-arterial chemotherapy under general anesthesia
• • Residual intra-arterial chemotherapy ≥ 2 times (cross-over design)
• Exclusion Criteria:
• • Respiratory disease causing a decrease in lung compliance
• • Unstable vital sign, significant arrhythmia or hypotension, Shock
• • Hypersensitivity or contraindication to nitroglycerin
• • Increased intracranial pressure, Intracranial hemorrhage
• • Recent use of PDE5 inhibitors (\<24 hours after sildenafil or vardenafil; \<48 hours after tadalafil)