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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ondansetron every 3 weeks combined with aprepitant and dexamethasone | Experimental |
| |
| Ondansetron weekly combined with aprepitant and dexamethasone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron every 3 weeks | Drug | Ondansetron, Po, 24mg/d, 3 days' application every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete response(CR) rate | Defined as no emesis and no rescue therapy | Up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed every week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guang Han, MD | Contact | 13886048178 | hg7913@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Guang Han, MD | Hubei Cancer Hospital, Wuhan, HuBei, China, 430079 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hubei Cancer Hospital | Recruiting | Wuhan | Hubei | 430079 | China |
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Parallel Assignment
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| Aprepitant | Drug | aprepitant, Po, 125mg/d, 1day' application every 3 weeks |
|
| Dexamethasone | Drug | dexamethasone, iv, 10mg/d, 1day' application every 3 weeks |
|
| Ondansetron weekly | Drug | Ondansetron, Po, 24mg/d, 3 days' application weekly |
|
| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077608 | Aprepitant |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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