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

Pediatric Cancer Clinical Trial

Official title:

Continuous Infusion of First-Generation 5-HT3 Receptor Antagonists in Combination With Dexamethasone. Can This Modality Improve the Antiemetic Effect

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05872893
• Other study ID #: IMMONC0009
• Status: Recruiting
• Phase: Phase 3
• Start date: June 27, 2023
• Est. completion date: January 2025

Study information

• Verified date: July 2023
• Source: Immune Oncology Research Institute
• Contact: Julieta Hoveyan, MD
• Phone: +374 (10) 283800
• Email: julia.hoveyan95[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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, the investigators suggest a continuous infusion of first-generation 5-HT3 receptor antagonists in combination with Dexamethasone as an alternative with potential superior activity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

Drug:
• Ondansetron
Patients will receive age-adjusted doses of ondansetron 5mg/m2
• Dexamethasone
Patients will receive dexamethasone 4mg/m2

Locations

Country	Name	City	State
Armenia	Hematology Center named after prof. R. Yeolyan	Yerevan

Sponsors (1)

Lead Sponsor	Collaborator
Immune Oncology Research Institute

Country where clinical trial is conducted

Armenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean nausea score per patient	Mean nausea score will be calculated as a weighted average of the Visual Analogue Scale (VAS) or Baxter Animated Retching Faces (BARF) scale observations during each cycle of chemotherapy.	20 months
Secondary	Correlation between mean nausea score and demographic variables		20 months
Secondary	Correlation between mean nausea score and disease characteristics		20 months