Continuous Infusion of First-Generation 5-HT3 Receptor Antagonists in Combination With Dexamethasone
Study Details
Study Description
Brief 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, we suggest a continuous infusion of the above-mentioned drug combination as an alternative with potential superior activity.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Detailed Description
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. It is estimated that 70-80% of patients receiving different chemotherapy regimens can experience emesis. 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. Currently, the three categories of drugs with the highest therapeutic index for preventing chemotherapy-induced nausea and vomiting are 5-HT3 receptor antagonists, NK1 receptor antagonists, and glucocorticoids (particularly Dexamethasone). Second-generation 5-HT3 receptor antagonists and NK1 receptor antagonists are more effective due to their prolonged influence but are very expensive and not available in the majority of resource-limited settings. Moreover, NK1 receptor antagonists are not still widely recommended for use in children < 12 years of age. First-generation 5-HT3 receptor antagonists in combination with Dexamethasone have proven superior activity compared to single agents. It is estimated that slow infusion of the above-mentioned agents can provide long-lasting stable concentrations of drugs in the blood serum contributing to better effect development. It has been shown that Ondansetron continuous infusion has superior efficacy in preventing postsurgical nausea and vomiting. Therefore, we suggest a continuous infusion of first-generation 5-HT3 receptor antagonists in combination with Dexamethasone as an alternative with potential superior activity.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: ondansetron + dexamethasone, continuous infusion Patients will receive a continuous infusion of age-adjusted doses of first-generation 5-HT3 receptor antagonist ondansetron in combination with dexamethasone |
Drug: Ondansetron
Patients will receive age-adjusted doses of ondansetron 5mg/m2
Drug: Dexamethasone
Patients will receive dexamethasone 4mg/m2
|
Active Comparator: ondansetron + dexamethasone, push injection Patients will receive standard i/v push injections of first-generation 5-HT3 receptor antagonist ondansetron and dexamethasone |
Drug: Ondansetron
Patients will receive age-adjusted doses of ondansetron 5mg/m2
Drug: Dexamethasone
Patients will receive dexamethasone 4mg/m2
|
Outcome Measures
Primary Outcome Measures
- Mean nausea score per patient [20 months]
Mean nausea score will be calculated as a weighted average of the VAS or BARF scale observations during each cycle of chemotherapy.
Secondary Outcome Measures
- Correlation between mean nausea score and demographic variables [20 months]
- Correlation between mean nausea score and disease characteristics [20 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients aged from 1 day to 18 years who are diagnosed with cancer and are eligible for chemotherapy.
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Voluntarily agree to participate by giving written parental permission and child assent.
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Patients with sufficient cardiac function, as determined by the investigator.
Exclusion Criteria:
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Patients with a history of severe hypersensitivity reactions or anaphylaxis related to the use of 5-HT3 receptor antagonists.
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Patients receiving concurrent chemo-radiation therapy.
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Patients diagnosed with cardiac arrhythmias and congenital long QT interval syndrome.
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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).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hematology Center named after prof. R. Yeolyan | Yerevan | Armenia | 0014 |
Sponsors and Collaborators
- Immune Oncology Research Institute
Investigators
- Principal Investigator: Julieta Hoveyan, MD, Immune Oncology Research Institute
- Study Chair: Ruzanna Papyan, MD, Immune Oncology Research Institute
- Study Chair: Samvel Bardakhchyan, MD, PhD, Immune Oncology Research Institute
- Study Director: Gevorg Tamamyan, MD, PhD, DSc, Immune Oncology Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IMMONC0009