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Trial Title:
Continuous Infusion of First-Generation 5-HT3 Receptor Antagonists in Combination With Dexamethasone
NCT ID:
NCT05872893
Condition:
Pediatric Cancer
Conditions: Official terms:
Dexamethasone
Ondansetron
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
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.
Primary purpose:
Supportive Care
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.
Intervention:
Intervention type:
Drug
Intervention name:
Ondansetron
Description:
Patients will receive age-adjusted doses of ondansetron 5mg/m2
Arm group label:
ondansetron + dexamethasone, continuous infusion
Arm group label:
ondansetron + dexamethasone, push injection
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Patients will receive dexamethasone 4mg/m2
Arm group label:
ondansetron + dexamethasone, continuous infusion
Arm group label:
ondansetron + dexamethasone, push injection
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.
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, the investigators suggest a continuous infusion of first-generation 5-HT3
receptor antagonists in combination with Dexamethasone as an alternative with potential
superior activity.
Criteria for eligibility:
Criteria:
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).
Gender:
All
Minimum age:
N/A
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hematology Center named after prof. R. Yeolyan
Address:
City:
Yerevan
Zip:
0014
Country:
Armenia
Status:
Recruiting
Contact:
Last name:
Julieta Hoveyan, MD
Phone:
+374 (010) 283800
Email:
julia.hoveyan95@gmail.com
Start date:
June 27, 2023
Completion date:
January 2025
Lead sponsor:
Agency:
Immune Oncology Research Institute
Agency class:
Other
Source:
Immune Oncology Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05872893
