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Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV)

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ClinicalTrials.gov Identifier: NCT02933099
Recruitment Status : Unknown
Verified October 2016 by Ting Hu, Wuhan Union Hospital, China.
Recruitment status was:  Not yet recruiting
First Posted : October 14, 2016
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
Ting Hu, Wuhan Union Hospital, China

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.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Nausea and Vomiting Drug: Aprepitant+palonosetron+dexamethasone Drug: palonosetron+dexamethasone Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Study Start Date : October 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Aprepitant arm
Aprepitant+palonosetron+dexamethasone
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)
Other Name: PDA

Active Comparator: Control arm
palonosetron+dexamethasone
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)
Other Name: PD




Primary Outcome Measures :
  1. Complete response [ Time Frame: 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 Outcome Measures :
  1. Acute Phase Response [ Time Frame: 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.

  2. Delayed Phase Response [ Time Frame: >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.

  3. Functional Living Index -Emesis (FLIE) [ Time Frame: Up to 10 days ]
  4. Safety and tolerability as measured by the incidence and severity of adverse [ Time Frame: 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Responsible Party: Ting Hu, MD, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT02933099     History of Changes
Other Study ID Numbers: WuhanUHC
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Aprepitant
Fosaprepitant
BB 1101
Palonosetron
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Serotonin Antagonists
Serotonin Agents