Nausea With Vomiting Chemotherapy-InducedNCT06080880
Ondanstron Weekly vs Every 3 Weeks for Prevention of Nausea and Vomiting Induced by Chemotherapy Combined With PD-1 Blockade
A study testing Ondansetron every 3 weeks, Aprepitant and Dexamethasone in people with Nausea With Vomiting Chemotherapy-Induced, run by Hubei Cancer Hospital at 1 site in China.
Trial summary
The aim of this randomized study is to compare the efficacy and safety of ondanstron weekly with every 3 weeks for the prevention of nausea and vomiting induced by chemotherapy combined with PD-1 blockade. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea With Vomiting Chemotherapy-Induced
- What is being tested?
- Ondansetron every 3 weeks, Aprepitant and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, no gender limit;
- Pathologically or cytologically confirmed malignant solid tumors;
- Scheduled to receive cisplatin-based chemotherapy combined with PD-1 blockade；
- TPS > 1 %(PD-1);
- Adequate hematological function (leucocyte count ≥ 4000/μL [to convert to ×109/L,multiply by 0.001], hemoglobin ≥ 9.00 g/dL [to convert to grams per liter, multiply by 10], and platelet count ≥ 100 × 103/μL [to convert to ×109/L, multiply by 1]);
- Hepatic function (alanine aminotransferase and aspartate aminotransferase ≤ 2.0 times the upper limit of the reference ranges), and renal function (creatinine clearance ≥ 60 mL/min/1.73 m2 [to convert to millimeters per second per meter-squared, multiply by 0.0167])；
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- Estimated survival time > 6 months；
- ECOG 0-1 points；
- Participants being informed and signed written consents.
Who cannot join
- Nausea or vomiting caused by reasons except for chemotherapy and PD-1 blockade;
- Participants with other malignant tumors history previously;
- Inability to read, comprehend, and finish questionnaires;
- Allergic to the drugs included in this study.
- Administered drugs with antiemetic activity within the 24 hours before receiving the first dose of study medication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Han Guang, MD
Han Guang, MD
About this study
Official title: Ondanstron Weekly vs Every 3 Weeks for Prevention of Nausea and Vomiting Induced by Chemotherapy Combined With PD-1 Blockade：an Randomized Clinical Trial
The aim of this randomized study is to compare the efficacy and safety of ondanstron weekly with every 3 weeks for the prevention of nausea and vomiting induced by chemotherapy combined with PD-1 blockade.
Read the detailed description
Nausea and vomiting have become the most common and intolerant adverse events in patients receiving chemotherapy, which cause substantial impairments in human functions and quality of life. In some serious cases, patients refused further treatment and lead to disruption of the course of treatment.
For highly emetogenic chemotherapy(HEC), a standard triple therapy including 5-hydroxytryptamine-3 receptor antagonist(5-HT3RA), neurokinin-1 receptor antagonist(NK-1RA) plus corticosteriod. Recently, a few trials have achieved success in reduction of post-discharge application of corticosteriod based on the standard triple therapy, which offered new insights to update the current therapeutic regimens.
Although the emetogenicity of PD-1 blockade seems to be slighter than HEC, previous studies have reported gastrointestinal immune-related adverse events(GI-IrAE) in patients treated with PD-1 blockade, of which 55% of the participants suffered nausea and vomiting. Noteworthy, recently researchers highlight the importance of prevention and control of nausea more than that of vomiting in terms with chemotherapy-induced nausea and vomiting.
Therefore, the investigators initiated this study to compare the efficacy and safety of ondanstron weekly with every 3 weeks for the prevention of nausea and vomiting induced by chemotherapy combined with PD-1 blockade, which may provide new insights for fully prevention and control compare the efficacy and safety of ondanstron weekly with every 3 weeks for the prevention of nausea and vomiting induced by chemotherapy combined with PD-1 blockade in aimed population.
- Being tested
- Ondansetron every 3 weeks, Aprepitant, Dexamethasone, Ondansetron weekly
- Keywords
- Chemotherapy-induced nausea and vomiting, PD-1 blockade, Ondanstron
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron every 3 weeksDrug
Ondansetron, Po, 24mg/d, 3 days' application every 3 weeks
AprepitantDrug
aprepitant, Po, 125mg/d, 1day' application every 3 weeks
DexamethasoneDrug
dexamethasone, iv, 10mg/d, 1day' application every 3 weeks
Ondansetron weeklyDrug
Ondansetron, Po, 24mg/d, 3 days' application weekly
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron every 3 weeks combined with aprepitant and dexamethasone | Experimental | Not described Receives: Drug: Ondansetron every 3 weeks; Drug: Aprepitant; Drug: Dexamethasone |
| Ondansetron weekly combined with aprepitant and dexamethasone | Experimental | Not described Receives: Drug: Aprepitant; Drug: Dexamethasone; Drug: Ondansetron weekly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response(CR) rate
Defined as no emesis and no rescue therapy
Measured: Up to 6 weeks
Secondary outcomes (1)
The proportion of patients with sustained no emesis, sustained no nausea, sustained no significant nausea, and the mean time to first emetic episode.
The proportion of patients with sustained no emesis, sustained no nausea, sustained no significant nausea (defined as no or mild nausea), and the mean time to first emetic episode.
Measured: Assessed every week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 Dec 2023
- Primary completionNov 2025 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea With Vomiting Chemotherapy-InducedStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hubei Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HAN GUANG, Hubei Cancer Hospital
- Investigators
- Guang Han, MD, Principal investigator, Hubei Cancer Hospital, Wuhan, HuBei, China, 430079
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080880
- Sponsor's protocol ID
- 2023-143-001
- Status last verified
- Feb 2024
- First submitted
- 8 Oct 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ondanstron Weekly vs Every 3 Weeks for Prevention of Nausea and Vomiting Induced by Chemotherapy Combined With PD-1 Blockade：an Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06080880
- Acronym / sponsor ID
- 2023-143-001
- Keywords
- Chemotherapy-induced nausea and vomiting, PD-1 blockade, Ondanstron
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Hubei Cancer HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 12 Oct 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.
The aim of this randomized study is to compare the efficacy and safety of ondanstron weekly with every 3 weeks for the prevention of nausea and vomiting induced by chemotherapy combined with PD-1 blockade.
Detailed description
Nausea and vomiting have become the most common and intolerant adverse events in patients receiving chemotherapy, which cause substantial impairments in human functions and quality of life. In some serious cases, patients refused further treatment and lead to disruption of the course of treatment.
For highly emetogenic chemotherapy(HEC), a standard triple therapy including 5-hydroxytryptamine-3 receptor antagonist(5-HT3RA), neurokinin-1 receptor antagonist(NK-1RA) plus corticosteriod. Recently, a few trials have achieved success in reduction of post-discharge application of corticosteriod based on the standard triple therapy, which offered new insights to update the current therapeutic regimens.
Although the emetogenicity of PD-1 blockade seems to be slighter than HEC, previous studies have reported gastrointestinal immune-related adverse events(GI-IrAE) in patients treated with PD-1 blockade, of which 55% of the participants suffered nausea and vomiting. Noteworthy, recently researchers highlight the importance of prevention and control of nausea more than that of vomiting in terms with chemotherapy-induced nausea and vomiting.
Therefore, the investigators initiated this study to compare the efficacy and safety of ondanstron weekly with every 3 weeks for the prevention of nausea and vomiting induced by chemotherapy combined with PD-1 blockade, which may provide new insights for fully prevention and control compare the efficacy and safety of ondanstron weekly with every 3 weeks for the prevention of nausea and vomiting induced by chemotherapy combined with PD-1 blockade in aimed population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Ondansetron every 3 weeks combined with aprepitant and dexamethasone | Experimental | Drug: Ondansetron every 3 weeks, Drug: Aprepitant, Drug: Dexamethasone |
| Ondansetron weekly combined with aprepitant and dexamethasone | Experimental | Drug: Aprepitant, Drug: Dexamethasone, Drug: Ondansetron weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years, no gender limit;
- Pathologically or cytologically confirmed malignant solid tumors;
- Scheduled to receive cisplatin-based chemotherapy combined with PD-1 blockade；
- TPS > 1 %(PD-1);
- Adequate hematological function (leucocyte count ≥ 4000/μL [to convert to ×109/L,multiply by 0.001], hemoglobin ≥ 9.00 g/dL [to convert to grams per liter, multiply by 10], and platelet count ≥ 100 × 103/μL [to convert to ×109/L, multiply by 1]);
Key exclusion criteria (5 listed)
- Nausea or vomiting caused by reasons except for chemotherapy and PD-1 blockade;
- Participants with other malignant tumors history previously;
- Inability to read, comprehend, and finish questionnaires;
- Allergic to the drugs included in this study.
- Administered drugs with antiemetic activity within the 24 hours before receiving the first dose of study medication.
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 |
|---|---|---|
| Ondansetron every 3 weeksOndansetron, Po, 24mg/d, 3 days' application every 3 weeks | Drug | Ondansetron every 3 weeks combined with aprepitant and dexamethasone |
| Aprepitantaprepitant, Po, 125mg/d, 1day' application every 3 weeks | Drug | Ondansetron every 3 weeks combined with aprepitant and dexamethasone, Ondansetron weekly combined with aprepitant and dexamethasone |
| Dexamethasonedexamethasone, iv, 10mg/d, 1day' application every 3 weeks | Drug | Ondansetron every 3 weeks combined with aprepitant and dexamethasone, Ondansetron weekly combined with aprepitant and dexamethasone |
| Ondansetron weeklyOndansetron, Po, 24mg/d, 3 days' application weekly | Drug | Ondansetron weekly combined with aprepitant and dexamethasone |
Primary outcome
Complete response(CR) rate
Time frame: Up to 6 weeks
Defined as no emesis and no rescue therapy
1 secondary outcome
The proportion of patients with sustained no emesis, sustained no nausea, sustained no significant nausea, and the mean time to first emetic episode.
Time frame: Assessed every week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Guang Han, MD principal investigator
Hubei Cancer Hospital, Wuhan, HuBei, China, 430079
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ondansetron every 3 weeks, Aprepitant and Dexamethasone in people with Nausea With Vomiting Chemotherapy-Induced, run by Hubei Cancer Hospital at 1 site in China.
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 9 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 29 Feb 2024. 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 China. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guang Han, MD (13886048178, hg7913@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response(CR) rate (time frame: Up to 6 weeks). 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 29 Feb 2024.