NCT05872893CompletedPhase 3
Continuous Infusion of First-Generation 5-HT3 Receptor Antagonists in Combination With Dexamethasone
Continuous Infusion of First-Generation 5-HT3 Receptor Antagonists in Combination With Dexamethasone. Can This Modality Improve the Antiemetic Effect
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
Chemotherapy-induced nausea and vomiting are serious side effects of cancer treatment that can have a significant negative impact on a patient's quality of life. Although the prevalence of nausea and vomiting has significantly decreased due to the implementation of new antiemetic drugs, several studies revealed that approximately 30% to 60% of patients still complain of acute or delayed chemotherapy-induced emesis. It is estimated that slow infusion of ondansetron in combination with dexamethasone can provide long-lasting stable concentrations of drugs in the blood serum contributing to better effect development. Therefore, the investigators suggest a continuous infusion of the above-mentioned drug combination as an alternative with potential superior activity.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 28 (actual)
- First submitted
- 15 May 2023
- Start date
- 27 Jun 2023
- Primary completion date
- 30 Jan 2025
- Lead sponsor
- Immune Oncology Research Institute
- Diseases
- Childhood cancers
- NCT number
- NCT05872893
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 28
- From 27 Jun 2023 to the primary completion date, 30 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving concurrent chemo-radiation therapy.
- 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).
Other illness
- Patients with a history of severe hypersensitivity reactions or anaphylaxis related to the use of 5-HT3 receptor antagonists.
Lab values
- Patients diagnosed with cardiac arrhythmias and congenital long QT interval syndrome.
Who the study is looking for
- 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.
Age in the registry: - to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hematology Center named after prof. R. Yeolyan Coordinator of this site? Confirm its status | Yerevan | Armenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.