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Olanzapine or Dexamethasone, With 5-HT3 RA and NK-1 RA, to Prevent CINV

Primary Purpose

Chemotherapy-induced Nausea and Vomiting

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Olanzapine+NK-1 RA+5-HT3 RA

Dexamethasone+NK-1 RA+5-HT3 RA

About this trial

This is an interventional treatment trial for Chemotherapy-induced Nausea and Vomiting focused on measuring nausea, vomiting, antiemesis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (Patients are eligible to be included in the study only if they meet all of the following criteria):

Cancer patients, age ≥ 18 years and ≤75 years, ECOG score 0-2 points, receiving cisplatin-containing doublet chemotherapy such as cisplatin + gemcitabine / albumin paclitaxel / etoposide /fluorouracil / irinotecan / temozolomide as first line treatment;
Life expectancy ≥ 3 months;
Leucocytes≥3,000/uL;
AST≤2.5 × upper limit of normal;
Bilirubin ≤1.5 × upper limit of normal;
Serum creatinine ≤ 1.5 × upper limit of normal.

Exclusion Criteria (Patients will be excluded if any of the following criteria is met):

History of CNS disease, such as brain metastases or epilepsy;
Use of other antipsychotic drugs (such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone, or such treatment is under scheduling during the study) within 30 days before enrollment; long-term use of phenothiazine as an antipsychotic agent;
Concurrent use of pharyngeal or abdominal radiotherapy;
Concurrent use of quinolone antibiotics;
Chronic alcoholism;
Known hypersensitivity to olanzapine;
Know arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within 6 months;
Known uncontrolled diabetes mellitus;
Vomiting or retching 24 hours before chemotherapy;
Use of anti-emesis drugs 48 hours before chemotherapy;
Concurrent use of amifostine;
Concurrent use of corticosteroids and the only anti-allergic choice is corticosteroids

Sites / Locations

Fifth Affilliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Olanzapine+NK-1 RA+5-HT3 RA

Dexamethasone+NK-1 RA+5-HT3 RA

Arm Description

Using one of the 5-HT3 receptor antagonists (a. Palonosetron: 0.25 mg d1 intravenous; b. Granisetron: 1 mg d1 intravenously, or 2 mg d1 orally; c. Ondansetron: 8-16 mg d1 intravenous or oral. the specific agent is chosen by the primary clinician, and is only delivered on the first day) within 30 minutes before cisplatin. Using one of the NK-1 receptor antagonists(a. Aprepitant: 125 mg orally, d1, 80 mg orally, d2-3; b. Fosaprepitant: 150 mg intravenously, d1) within 1 hour before cisplatin. On day 1-4, Olanzapine (5mg) is delivered orally after dinner.

Using one of the 5-HT3 receptor antagonists (a. Palonosetron: 0.25 mg d1 intravenous; b. Granisetron: 1 mg d1 intravenously, or 2 mg d1 orally; c. Ondansetron: 8-16 mg d1 intravenous or oral. the specific agent is chosen by the primary clinician, and is only delivered on the first day) within 30 minutes before cisplatin. Using one of the NK-1 receptor antagonists (a. Aprepitant: 125 mg orally, d1, 80 mg orally, d2-3; b. Fosaprepitant: 150 mg intravenously, d1) within 1 hour before cisplatin. On first day, dexamethasone (12 mg) is given orally/intravenously within 30 minutes before cisplatin administered, and on day 2-4, the given dose of dexamethasone is 8 mg.

Outcomes

Primary Outcome Measures

0-120h Complete Remission Rate

The ratio of patients who have no vomiting and apply no anti-nausea drugs during the whole observation period.

Secondary Outcome Measures

25-120 hours Complete Remission Rate

The ratio of patients who have no vomiting and apply no anti-nausea drugs during the 25-120 hours observation period.

0-120h No Nausea Rate

The ratio of patients who have no nausea during the whole observation period.

Full Information

NCT ID

NCT04437017

First Posted

June 16, 2020

Last Updated

July 26, 2022

Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

1. Study Identification

Unique Protocol Identification Number

NCT04437017

Brief Title

Olanzapine or Dexamethasone, With 5-HT3 RA and NK-1 RA, to Prevent CINV

Official Title

Olanzapine or Dexamethasone, With 5-HT3 RA and NK-1 RA, to Prevent Nausea and Vomiting Induced by Cisplatin-Based Doublet Chemotherapy: A Non-inferiority, Prospective, Multi-Centered, Randomized, Controlled, Phase III Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

February 3, 2020 (Actual)

Primary Completion Date

May 1, 2022 (Actual)

Study Completion Date

July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

Chemotherapy-induced nausea and vomiting is a common side effect of cancer treatments, and dexamethasone offers a clear advantage over placebo for protection against chemotherapy-induced emesis in both acute and delayed phases. However, its side effects such as moderate to severe insomnia, hyperglycemia, dyspepsia, upper abdominal discomfort, irritability, increased appetite, weight gain and acne are gathering increasing concerns. Several clinical trials have shown that olanzapine plays an important role in treating delayed, refractory, breakthrough nausea and vomiting. Its side effects mainly include sedation and weight gaining. At present, the NCCN guidelines have recommended olanzapine-containing three-drug regimen for Highly Emetogenic Chemotherapy (HEC) and moderate emetic chemotherapy (MEC) to prevent vomiting, but its data in the Chinese population is limited. Hence, we initiated this prospective, multi-center, phase III study to validate the dexamethasone-free protocol: applying olanzapine to prevent CINV instead of dexamethasone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chemotherapy-induced Nausea and Vomiting

Keywords

nausea, vomiting, antiemesis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

557 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Olanzapine+NK-1 RA+5-HT3 RA

Arm Type

Experimental

Arm Description

Arm Title

Dexamethasone+NK-1 RA+5-HT3 RA

Arm Type

Active Comparator

Arm Description

Using one of the 5-HT3 receptor antagonists (a. Palonosetron: 0.25 mg d1 intravenous; b. Granisetron: 1 mg d1 intravenously, or 2 mg d1 orally; c. Ondansetron: 8-16 mg d1 intravenous or oral. the specific agent is chosen by the primary clinician, and is only delivered on the first day) within 30 minutes before cisplatin. Using one of the NK-1 receptor antagonists (a. Aprepitant: 125 mg orally, d1, 80 mg orally, d2-3; b. Fosaprepitant: 150 mg intravenously, d1) within 1 hour before cisplatin. On first day, dexamethasone (12 mg) is given orally/intravenously within 30 minutes before cisplatin administered, and on day 2-4, the given dose of dexamethasone is 8 mg.

Intervention Type

Drug

Intervention Name(s)

Olanzapine+NK-1 RA+5-HT3 RA

Intervention Description

On day 1-4, Olanzapine (5mg) is delivered orally after dinner.

Intervention Type

Drug

Intervention Name(s)

Dexamethasone+NK-1 RA+5-HT3 RA

Other Intervention Name(s)

Acidocont, Deronil, Dexacortal, Desameton, Fluprednisolone, (11β，16α）-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione

Intervention Description

On first day, dexamethasone (12 mg) is given orally/intravenously within 30 minutes before cisplatin administrated, and on day 2-4, the given dose of dexamethasone is 8 mg.

Primary Outcome Measure Information:

Title

0-120h Complete Remission Rate

Description

The ratio of patients who have no vomiting and apply no anti-nausea drugs during the whole observation period.

Time Frame

24 hours ,48 hours, 72 hours, 96 hours, 120 hours after chemotherapy

Secondary Outcome Measure Information:

Title

25-120 hours Complete Remission Rate

Description

The ratio of patients who have no vomiting and apply no anti-nausea drugs during the 25-120 hours observation period.

Time Frame

24 hours , 48 hours, 72 hours, 96 hours, 120 hours after chemotherapy

Title

0-120h No Nausea Rate

Description

The ratio of patients who have no nausea during the whole observation period.

Time Frame

24 hours, 48 hours, 72 hours, 96 hours, 120 hours after chemotherapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria (Patients are eligible to be included in the study only if they meet all of the following criteria): Cancer patients, age ≥ 18 years and ≤75 years, ECOG score 0-2 points, receiving cisplatin-containing doublet chemotherapy such as cisplatin + gemcitabine / albumin paclitaxel / etoposide /fluorouracil / irinotecan / temozolomide as first line treatment; Life expectancy ≥ 3 months; Leucocytes≥3,000/uL; AST≤2.5 × upper limit of normal; Bilirubin ≤1.5 × upper limit of normal; Serum creatinine ≤ 1.5 × upper limit of normal. Exclusion Criteria (Patients will be excluded if any of the following criteria is met): History of CNS disease, such as brain metastases or epilepsy; Use of other antipsychotic drugs (such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone, or such treatment is under scheduling during the study) within 30 days before enrollment; long-term use of phenothiazine as an antipsychotic agent; Concurrent use of pharyngeal or abdominal radiotherapy; Concurrent use of quinolone antibiotics; Chronic alcoholism; Known hypersensitivity to olanzapine; Know arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within 6 months; Known uncontrolled diabetes mellitus; Vomiting or retching 24 hours before chemotherapy; Use of anti-emesis drugs 48 hours before chemotherapy; Concurrent use of amifostine; Concurrent use of corticosteroids and the only anti-allergic choice is corticosteroids

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhigang Liu, M.D.

Organizational Affiliation

Fifth Affilliated Hospital of Sun Yat-sen University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Zhigang Liu, M.D.

Organizational Affiliation

Fifth Affilliated Hospital of Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fifth Affilliated Hospital of Sun Yat-sen University

City

Zhuhai

State/Province

Guangdong

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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Olanzapine or Dexamethasone, With 5-HT3 RA and NK-1 RA, to Prevent CINV

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