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Continuous Infusion of First-Generation 5-HT3 Receptor Antagonists in Combination With Dexamethasone

NCT05872893 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-07-21

No results posted yet for this study

Summary

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.

Conditions

  • Pediatric Cancer

Interventions

DRUG

Ondansetron

Patients will receive age-adjusted doses of ondansetron 5mg/m2

DRUG

Dexamethasone

Patients will receive dexamethasone 4mg/m2

Sponsors & Collaborators

  • Immune Oncology Research Institute

    lead OTHER

Principal Investigators

  • Julieta Hoveyan, MD · Immune Oncology Research Institute

  • Ruzanna Papyan, MD · Immune Oncology Research Institute

  • Samvel Bardakhchyan, MD, PhD · Immune Oncology Research Institute

  • Gevorg Tamamyan, MD, PhD, DSc · Immune Oncology Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-27
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • Armenia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05872893 on ClinicalTrials.gov