Using nitroglycerin to reduce side effects of chemotherapy in children with retinoblastoma
The Effect of Nitroglycerin on the Incidence of Cardiorespiratory Side Effect During the Intra-arterial Chemotherapy in Pediatric Patients With Retinoblastoma: a Randomized, Double-blind, Placebo-controlled, Crossover Study
This study is testing if giving nitroglycerin to children with retinoblastoma during chemotherapy can help reduce heart and breathing problems caused by the treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | N/A to 7 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04564521 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of intravenously infused nitroglycerin on reducing cardio-respiratory side effects during intra-arterial chemotherapy for pediatric retinoblastoma. The treatment involves administering nitroglycerin to dilate the retinal artery, which may help mitigate adverse effects such as bradycardia and hypotension that can occur during catheter manipulation. The study aims to improve the safety and efficacy of chemotherapy delivery in young patients with this condition. Participants will be monitored for side effects and overall treatment response.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients diagnosed with retinoblastoma who require intra-arterial chemotherapy under general anesthesia.
Not a fit: Patients with pre-existing respiratory diseases, unstable vital signs, or contraindications to nitroglycerin will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the safety of intra-arterial chemotherapy for children with retinoblastoma.
How similar studies have performed: While the specific use of nitroglycerin in this context may be novel, similar approaches to mitigate chemotherapy side effects have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Seoul
- Jin-Tae Kim — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Young-Eun Jang, MD
- Email: na0ag2@hotmail.com
- Phone: 82-2-2072-3664
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.