Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting

Chemotherapy-induced Nausea and Vomiting Clinical Trial

— CINV  

Official title:

Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting Following High-dose Cisplatin in Nasopharyngeal Carcinoma Patients：a Randomized Phase 3 Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02933099
• Other study ID #: WuhanUHC
• 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

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

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