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

NCT05872893 | Unknown Phase 3

• 1 other identifier: IMMONC0009
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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, the investigators suggest a continuous infusion of the above-mentioned drug combination as an alternative with potential superior activity.

Conditions

Pediatric Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Correlation between mean nausea score and demographic variables

  20 months

• Correlation between mean nausea score and disease characteristics

  20 months

Study Arms (2)

ondansetron + dexamethasone, continuous infusion

EXPERIMENTAL

Patients will receive a continuous infusion of age-adjusted doses of first-generation 5-HT3 receptor antagonist ondansetron in combination with dexamethasone

Drug: Ondansetron; Drug: Dexamethasone

ondansetron + dexamethasone, push injection

ACTIVE COMPARATOR

Patients will receive standard i/v push injections of first-generation 5-HT3 receptor antagonist ondansetron and dexamethasone

Drug: Ondansetron; Drug: Dexamethasone

Interventions

Ondansetron DRUG

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

ondansetron + dexamethasone, continuous infusion; ondansetron + dexamethasone, push injection

Dexamethasone DRUG

Patients will receive dexamethasone 4mg/m2

ondansetron + dexamethasone, continuous infusion; ondansetron + dexamethasone, push injection

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Immune Oncology Research Institute: lead

Study Sites (1)

Hematology Center named after prof. R. Yeolyan

Yerevan, 0014, Armenia

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Ondansetron; Dexamethasone

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Julieta Hoveyan, MD

  Immune Oncology Research Institute

  PRINCIPAL INVESTIGATOR

• Ruzanna Papyan, MD

  Immune Oncology Research Institute

  STUDY CHAIR

• Samvel Bardakhchyan, MD, PhD

  Immune Oncology Research Institute

  STUDY CHAIR

• Gevorg Tamamyan, MD, PhD, DSc

  Immune Oncology Research Institute

  STUDY DIRECTOR

Central Study Contacts

Julieta Hoveyan, MD

CONTACT

+374 (10) 283800; julia.hoveyan95@gmail.com

Ruzanna Papyan, MD

CONTACT

+374 (10) 283800; ruzannapapyan92@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The experimental group will receive intravenous push injections of 0.9% sodium chloride before each infusion, and the control group will receive a 4-hour infusion of sodium chloride after each dose of push injection.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each patient will serve as his or her own control. Study participants will be randomly assigned to the sequence of treatment. If the patient is assigned to the experimental arm during the first cycle of chemotherapy, he or she will receive the comparator treatment during the second cycle and vice versa. Treatment modalities will follow each other throughout the whole study period. Mean nausea score during each chemotherapy cycle will be calculated. To achieve statistically significant results, 140 chemotherapy cycles must be included in the analysis.

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 24, 2023
• Study Start: June 27, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

AR (1)