Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting

NCT ID: NCT02933099

Last Updated: 2016-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-12-31

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.

Conditions

Chemotherapy-induced Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Aprepitant arm

Aprepitant+palonosetron+dexamethasone

Group Type: EXPERIMENTAL

Aprepitant+palonosetron+dexamethasone

Intervention Type: 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)

Control arm

palonosetron+dexamethasone

Group Type: ACTIVE_COMPARATOR

palonosetron+dexamethasone

Intervention Type: 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)

Interventions

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)

Intervention Type: DRUG

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)

Intervention Type: DRUG

Other Intervention Names

PDA; PD

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Ting Hu

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

WuhanUHC

Identifier Type: -

Identifier Source: org_study_id