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Completed

NCT Number: NCT02484911

Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting

The purpose of the study is to mainly evaluate the efficacy and safety of aprepitant in combination with olanzapine ,palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly or moderately emetogenic chemotherapy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

About this study

Eligible patients will be randomized to receive different antiemetic regimens . In the experimental group,patients will receive aprepitant,olanzapine ,palonosetron and dexamethasone .In the other group,patients will accept the same dose of aprepitant ,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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older
  • Histologically or cytologically confirmed malignant disease
  • Accept chemotherapy for the first time
  • Patients who will receive high emetogenic cancer chemotherapy (HEC) (cisplatin>=70mg/m2,adriamycin in combination with cyclophosphamide ,cyclophosphamide>=1500mg/m2,adriamycin>60mg/m2,epirubicin>90mg/m2,dacarbazine,ifosfamide>=2g/m2) or moderate emetogenic chemotherapy cancer (carboplatin>=300mg/m2,cyclophosphamide>=600-1000mg/m2,adriamycin>50mg/m2)
  • Written informed consent

Exclusion criteria

  • Pregnant or breast-feeding
  • Uncontrolled psychosis history
  • Inability or unwillingness to understand or cooperate with study procedures
  • Central nervous system tumors primary or secondary
  • Concurrent abdominal radiotherapy
  • History of uncontrolled diabetes mellitus
  • Patients of prostatic hyperplasia ,paralytic ileus,narrow feet glaucoma.
  • Known cardiac arrhythmia, uncontrolled congestive heart failure ,or acute myocardial infarction with the previous six month
  • Pre-existing nausea or vomiting
  • Inadequate hematological function and abnormal liver and renal function.
  • History of sensitivity to olanzapine
  • Concurrent application of quinolone antibiotic therapy
  • Treatment with another antipsychotic agent such as risperidone,quetiapine, clozapine,phenothiazine,or butyrophenone for 30 days prior to or during the chemotherapy.
  • Cytochrome P450 3A4 substrates within 7 days (terfenadine, cisapride, astemizole, pimozide)
  • Concurrent application of systemic corticosteroids
  • Active infection or gastrointestinal dysfunction

Treatment and study plan

Olanzapine

Drug

5mg,twice a day orally on day 1 to day 4

Aprepitant

Drug

125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.

Palonosetron

Drug

0.25mg IV 30-60min before chemotherapy on day 1

Dexamethasone

Drug

6mg IV on day 1 ,3.75mg IV on day 2 to 4

Primary outcomes

  1. Proportion of Participants Receiving HEC With Complete Response in Overall Phase

    Time frame: 0 to 120 hours

    Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.

    Complete response was defined as no vomiting with no rescue therapy.

  2. Proportion of Participants Receiving MEC With Complete Response in Overall Phase

    Time frame: 0 to 120 hours

    Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.

    Complete response was defined as no vomiting with no rescue therapy.

Secondary outcomes

  1. Proportion of Participants Receiving HEC With Complete Response in the Acute Phase

    Time frame: 0 to 24 hours

    Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.

  2. Proportion of Participants Receiving HEC With Complete Response in the Delayed Phase

    Time frame: 24 to 120 hours

    Delayed phase was defined as 24 to 120 hours following initiation of chemotherapy.

    Complete response was defined as no vomiting with no rescue therapy.

  3. Proportion of Participants Receiving HEC With No Vomiting in the Overall Phase

    Time frame: 0 to 120 hours

    Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.

    No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).

  4. Proportion of Participants Receiving HEC With No Vomiting in the Acute Phase

    Time frame: 0 to 24 hours

    Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.

    No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue )

  5. Proportion of Participants Receiving HEC With No Vomiting in the Delayed Phase

    Time frame: 24 to 120 hours

    Overall Phase was defined as 24 to 120 hours following initiation of chemotherapy.

    No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).

  6. Proportion of Participants Receiving MEC With Complete Response in the Acute Phase

    Time frame: 0 to 24 hours

    Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.

  7. Proportion of Participants Receiving MEC With Complete Response in the Delayed Phase

    Time frame: 24 to 120 hours

    Delayed phase was defined as 24 to 120 hours following initiation of chemotherapy.

    Complete response was defined as no vomiting with no rescue therapy.

  8. Proportion of Participants Receiving MEC With No Vomiting in the Overall Phase

    Time frame: 0-120 hours

    Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.

    No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).

  9. Proportion of Participants Receiving MEC With No Vomiting in the Acute Phase

    Time frame: 0 to 24 hours

    Overall Phase was defined as 0 to 24 hours following initiation of chemotherapy.

    No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).

  10. Proportion of Participants Receiving MEC With No Vomiting in the Delayed Phase

    Time frame: 24 to 120 hours

    Overall Phase was defined as 24 to 120 hours following initiation of chemotherapy.

    No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Harbin Medical University

Other

Collaborators

  • Harbin Medical University

Registry information

Official study title

Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting---A Randomized Single Center Phase III Trial

Acronym: AOPDPCINV

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 30, 2015
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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