Chemotherapy-induced Nausea and Vomiting
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGAprepitant+palonosetron+dexamethasone
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)
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)
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older 2. Histologically or cytologically confirmed nasopharyngeal carcinoma 3. Accept chemotherapy for the first time 4. Patients who will receive chemotherapy (docetaxel 60 mg/m2 intravenously (IV), cisplatin 60 mg/m2 IV, and 5-FU (5-Fluorouracil) 600 mg/m2 IV) 5. Written informed consent
Exclusion criteria
1. regnant or breast-feeding 2. Uncontrolled psychosis history 3. Inability or unwillingness to understand or cooperate with study procedures 4. Central nervous system tumors primary or secondary 5. Concurrent abdominal radiotherapy 6. History of uncontrolled diabetes mellitus 7. Patients of prostatic hyperplasia ，paralytic ileus，narrow feet glaucoma. 8. Known cardiac arrhythmia, uncontrolled congestive heart failure ,or acute myocardial infarction with the previous six month 9. Pre-existing nausea or vomiting 10. Inadequate hematological function and abnormal liver and renal function. 11. History of sensitivity to olanzapine 12. Concurrent application of quinolone antibiotic therapy 13. Treatment with another antipsychotic agent such as risperidone,quetiapine, clozapine,phenothiazine,or butyrophenone for 30 days prior to or during the chemotherapy. 14. Cytochrome P450 3A4 substrates within 7 days (terfenadine, cisapride, astemizole, pimozide) 15. Concurrent application of systemic corticosteroids 16. Active infection or gastrointestinal dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response | Up to 10 days | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Phase Response | 0 to 24 hours post chemotherapy | 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. |
| Delayed Phase Response | >24 to 10 days post chemotherapy | 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. |
| Functional Living Index -Emesis (FLIE) | Up to 10 days | — |
| Safety and tolerability as measured by the incidence and severity of adverse | Up to 10 days | To evaluate the safety and tolerability by the incidence and severity of adverse events during the treatment (0 to 120 hours post chemotherapy) |
Outcome results
None listed