Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare the antiemetic combination of palonosetron, dexamethasone, and aprepitant (PDA) with antiemetic combination of palonosetron and dexamethasone (PD) in nasopharyngeal carcinoma patients receiving docetaxel, cisplatin, and 5-FU based chemotherapy.
Eligible patients will be randomized to receive different antiemetic regimens . In the experimental group,patients will receive aprepitant, palonosetron and dexamethasone .In the other group,patients will accept the same dose of palonosetron and dexamethasone. During the treatment, any grade of nausea and vomiting should be recorded in order to evaluate the complete response rate of CINV,nausea patients will be measured by a visual analogue scale (VAS) ,other adverse events should be recorded as well.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aprepitant arm | Experimental | Aprepitant+palonosetron+dexamethasone |
|
| Control arm | Active Comparator | palonosetron+dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aprepitant+palonosetron+dexamethasone | Drug | Patients will receive the chemotherapy drugs as well as the following antiemetic drugs: aprepitant (125 mg orally on day 1 and 80 mg orally on days 2 and 3) plus palonosetron 0.25 mg IV and dexamethasone (20 mg orally on day 1 and 8 mg orally on days 2 and 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response | The primary endpoint is the rate of patients achieving a complete response(defined as no emetic episode and no use of rescue medication) during over all time (0 to 120 hours post chemotherapy) | Up to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Phase Response | To determine the effect on complete response(defined as no emetic episode and no use of rescue medication) rates in the acute (0 to 24 hours) phase of CINV. | 0 to 24 hours post chemotherapy |
| Delayed Phase Response |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| palonosetron+dexamethasone | Drug | Patients will receive the chemotherapy drugs as well as the following antiemetic drugs: palonosetron 0.25 mg IV and dexamethasone (12 mg orally on day 1 and 8 mg orally on days 2 and 3) |
|
|
To determine the effect on complete response (defined as no emetic episode and no use of rescue medication)rates in the delayed (>24 to 120 hours post chemotherapy) phase of CINV.
| >24 to 10 days post chemotherapy |
| Functional Living Index -Emesis (FLIE) | Up to 10 days |
| Safety and tolerability as measured by the incidence and severity of adverse | To evaluate the safety and tolerability by the incidence and severity of adverse events during the treatment (0 to 120 hours post chemotherapy) | Up to 10 days |