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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hematology Center named after prof. R. Yeolyan
Coordinator of this site? Confirm its status
YerevanArmeniaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.