Pediatric CancerPhase 3NCT05872893
Continuous Infusion of First-Generation 5-HT3 Receptor Antagonists in Combination With Dexamethasone
A Phase 3 study testing Ondansetron and Dexamethasone in people with Pediatric Cancer, run by Immune Oncology Research Institute at 1 site in Armenia.
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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Ondansetron and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteArmenia
- Study dates
- 27 Jun 2023to 30 Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Infusion of First-Generation 5-HT3 Receptor Antagonists in Combination With Dexamethasone. Can This Modality Improve the Antiemetic Effect
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.
Read the 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.
- Conditions
- Pediatric Cancer
- Being tested
- Ondansetron, Dexamethasone
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Patients will receive age-adjusted doses of ondansetron 5mg/m2
DexamethasoneDrug
Patients will receive dexamethasone 4mg/m2
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Ondansetron; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 months
Secondary outcomes (2)
Correlation between mean nausea score and demographic variables
Measured: 20 months
Correlation between mean nausea score and disease characteristics
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start27 Jun 2023
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immune Oncology Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julieta Hoveyan, MD, Principal investigator, Immune Oncology Research InstituteRuzanna Papyan, MD, Study chair, Immune Oncology Research InstituteSamvel Bardakhchyan, MD, PhD, Study chair, Immune Oncology Research InstituteGevorg Tamamyan, MD, PhD, DSc, Study director, Immune Oncology Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872893
- Sponsor's protocol ID
- IMMONC0009
- Status last verified
- Apr 2026
- First submitted
- 15 May 2023
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Infusion of First-Generation 5-HT3 Receptor Antagonists in Combination With Dexamethasone. Can This Modality Improve the Antiemetic Effect
- ClinicalTrials.gov ID
- NCT05872893
- Acronym / sponsor ID
- IMMONC0009
- Conditions
- Pediatric Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Immune Oncology Research InstituteUniversity, hospital or other
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ondansetron + dexamethasone, continuous infusion | Experimental | Drug: Ondansetron, Drug: DexamethasonePatients will receive a continuous infusion of age-adjusted doses of first-generation 5-HT3 receptor antagonist ondansetron in combination with dexamethasone |
| ondansetron + dexamethasone, push injection | Active comparator | Drug: Ondansetron, Drug: DexamethasonePatients will receive standard i/v push injections of first-generation 5-HT3 receptor antagonist ondansetron and dexamethasone |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OndansetronPatients will receive age-adjusted doses of ondansetron 5mg/m2 | Drug | ondansetron + dexamethasone, continuous infusion, ondansetron + dexamethasone, push injection |
| DexamethasonePatients will receive dexamethasone 4mg/m2 | Drug | ondansetron + dexamethasone, continuous infusion, ondansetron + dexamethasone, push injection |
Primary outcome
Mean nausea score per patient
Time frame: 20 months
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.
2 secondary outcomes
Correlation between mean nausea score and demographic variables
Time frame: 20 months
Correlation between mean nausea score and disease characteristics
Time frame: 20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julieta Hoveyan, MD principal investigator
Immune Oncology Research Institute
Ruzanna Papyan, MD study chair
Immune Oncology Research Institute
Samvel Bardakhchyan, MD, PhD study chair
Immune Oncology Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ondansetron and Dexamethasone in people with Pediatric Cancer, run by Immune Oncology Research Institute at 1 site in Armenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Armenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean nausea score per patient (time frame: 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.