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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02933099
Other study ID # WuhanUHC
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received October 7, 2016
Last updated October 11, 2016
Start date October 2016
Est. completion date December 2018

Study information

Verified date October 2016
Source Wuhan Union Hospital, China
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date December 2018
Est. primary completion date April 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Drug:
Aprepitant+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)
palonosetron+dexamethasone
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)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Wuhan Union Hospital, China

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary Delayed Phase Response 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 No
Secondary Functional Living Index -Emesis (FLIE) Up to 10 days No
Secondary 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 Yes
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