Continuous infusion of anti-nausea medication for pediatric cancer patients
Continuous Infusion of First-Generation 5-HT3 Receptor Antagonists in Combination With Dexamethasone. Can This Modality Improve the Antiemetic Effect
This study is testing if giving a steady dose of anti-nausea medication can help kids with cancer feel less sick during chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Immune Oncology Research Institute Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Yerevan) |
| Trial ID | NCT05872893 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of continuous infusion of first-generation 5-HT3 receptor antagonists, specifically Ondansetron, in combination with Dexamethasone, to manage chemotherapy-induced nausea and vomiting in pediatric cancer patients. The study aims to provide a more stable concentration of these medications in the bloodstream, potentially leading to improved control of nausea and vomiting compared to traditional dosing methods. Eligible participants include children aged 1 day to 18 years who are undergoing chemotherapy and have sufficient cardiac function. The trial excludes patients with severe hypersensitivity to the medications or those undergoing concurrent chemo-radiation therapy.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 1 day to 18 years diagnosed with cancer and eligible for chemotherapy.
Not a fit: Patients with a history of severe hypersensitivity reactions to 5-HT3 receptor antagonists or those receiving concurrent chemo-radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for pediatric cancer patients by reducing the incidence of chemotherapy-induced nausea and vomiting.
How similar studies have performed: Other studies have shown promising results with continuous infusion of antiemetics, but this specific approach with first-generation 5-HT3 receptor antagonists in pediatric patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged from 1 day to 18 years who are diagnosed with cancer and are eligible for chemotherapy. * Voluntarily agree to participate by giving written parental permission and child assent. * Patients with sufficient cardiac function, as determined by the investigator. Exclusion Criteria: * Patients with a history of severe hypersensitivity reactions or anaphylaxis related to the use of 5-HT3 receptor antagonists. * Patients receiving concurrent chemo-radiation therapy. * Patients diagnosed with cardiac arrhythmias and congenital long QT interval syndrome. * Known clinically significant drug interactions between chemotherapeutic agents and 5-HT3 receptor antagonists and/or Dexamethasone (e.g. more than 0.8 mg/ml concentrations of 5-fluorouracil may cause precipitation of ondansetron).
Where this trial is running
Yerevan
- Hematology Center named after prof. R. Yeolyan — Yerevan, Armenia (Recruiting)
Study contacts
- Principal investigator: Julieta Hoveyan, MD — Immune Oncology Research Institute
- Study coordinator: Julieta Hoveyan, MD
- Email: julia.hoveyan95@gmail.com
- Phone: +374 (10) 283800
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.