NCT04564521

Nitroglycerin for Intra-arterial Chemotherapy in Pediatric Retinoblastoma.

Status unknown NA Last updated 22 November 2023

What this trial tests

NA trial testing Nitroglycerin in Retinoblastoma in 36 participants. Status unknown.

Timeline

28 September 2020

Primary endpoint
30 June 2024

30 December 2024

Quick facts

Lead sponsor	Seoul National University Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	36
Start date	28 September 2020
Primary completion	30 June 2024
Estimated completion	30 December 2024
Sites	1 location across South Korea

Drugs / interventions tested

• Nitroglycerin (glyceryl trinitrate) — full drug profile →
• Normal saline

Conditions studied

• Retinoblastoma — all drugs for Retinoblastoma →

Sponsor

Seoul National University Hospital

Who can join

Under 7, any sex, with Retinoblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of the study is to evaluate the effect of intravenously infused nitroglycerin on the incidence of the cardio-respiratory side effects during the intra-arterial chemotherapy for retinoblastoma in pediatric patients.

The intra-arterial chemotherapy at the ophthalmic artery is an important treatment option for retinoblastoma. However, the cardio-respiratory side effects (sudden onset of bradycardia, hypotension, a severe decrease in the compliance of lung, hypoxia) occasionally occurs during catheter manipulation in the ophthalmic artery. One of the purported mechanisms of cardio-respiratory side effects is vagal activation from the activation of trigeminal ganglion by afferent signals from the ophthalmic artery. Additionally, the chemotherapy agent can cause intra-arterial retinal precipitates. Therefore, it is expected that the dilation of the retinal artery may reduce the cardio-respiratory side effects and intra-arterial retinal precipitates.

The hypothesis of this study is that the intravenously infused nitroglycerin will increase the compliance of the ophthalmic and retinal artery and decrease vagal stimulation and cardio-respiratory side effects during catheter manipulation and chemotherapy agent infusion. This is a single-center, double-blind, randomized, placebo-controlled study comparing the effect of intravenously infused nitroglycerin and saline on the incidence of the cardio-respiratory side effect in pediatric retinoblastoma patients undergoing intra-arterial chemotherapy. Prior to the procedure, each patient will be randomized into either the control-first arm, saline, or study-first arm, nitroglycerin.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current Advances of Nitric Oxide in Cancer and Anticancer Therapeutics.
   Mintz J, Vedenko A, Rosete O, Shah K, et al · · 2021 · cited 103× · PMID 33513777 · DOI 10.3390/vaccines9020094
2. Retinoblastoma: An update on genetic origin, classification, conventional to next-generation treatment strategies.
   Pareek A, Kumar D, Pareek A, Gupta MM, et al · · 2024 · cited 10× · PMID 38975183 · DOI 10.1016/j.heliyon.2024.e32844