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

Sponsor
Immune Oncology Research Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05872893
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
19.1
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

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

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
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.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.
Masking:
Single (Participant)
Masking Description:
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.
Primary Purpose:
Supportive Care
Official Title:
Continuous Infusion of First-Generation 5-HT3 Receptor Antagonists in Combination With Dexamethasone. Can This Modality Improve the Antiemetic Effect
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2025

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

  1. 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

  1. Correlation between mean nausea score and demographic variables [20 months]

  2. Correlation between mean nausea score and disease characteristics [20 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

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.
Responsible Party:
Immune Oncology Research Institute
ClinicalTrials.gov Identifier:
NCT05872893
Other Study ID Numbers:
  • IMMONC0009
First Posted:
May 24, 2023
Last Update Posted:
May 24, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Dexamethasone
Ondansetron

Study Results

No Results Posted as of May 24, 2023