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

Chemotherapy-induced Nausea and Vomiting Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04437017
• Other study ID #: No.ZDWY[2020]LunziNo.(K01-1)
• Status: Completed
• Phase: Phase 3
• Start date: February 3, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: May 2021
• Source: Fifth Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 557
• Est. completion date: July 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

1. 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;

2. Life expectancy = 3 months;

3. Leucocytes=3,000/uL;

4. AST=2.5 × upper limit of normal;

5. Bilirubin =1.5 × upper limit of normal;

6. Serum creatinine = 1.5 × upper limit of normal.

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

1. History of CNS disease, such as brain metastases or epilepsy;

2. 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;

3. Concurrent use of pharyngeal or abdominal radiotherapy;

4. Concurrent use of quinolone antibiotics;

5. Chronic alcoholism;

6. Known hypersensitivity to olanzapine;

7. Know arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within 6 months;

8. Known uncontrolled diabetes mellitus;

9. Vomiting or retching 24 hours before chemotherapy;

10. Use of anti-emesis drugs 48 hours before chemotherapy;

11. Concurrent use of amifostine;

12. Concurrent use of corticosteroids and the only anti-allergic choice is corticosteroids

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Drug:
• Olanzapine+NK-1 RA+5-HT3 RA
On day 1-4, Olanzapine (5mg) is delivered orally after dinner.
• Dexamethasone+NK-1 RA+5-HT3 RA
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.

Locations

Country	Name	City	State
China	Fifth Affilliated Hospital of Sun Yat-sen University	Zhuhai	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Fifth Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	0-120h Complete Remission Rate	The ratio of patients who have no vomiting and apply no anti-nausea drugs during the whole observation period.	24 hours ,48 hours, 72 hours, 96 hours, 120 hours after chemotherapy
Secondary	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.	24 hours , 48 hours, 72 hours, 96 hours, 120 hours after chemotherapy
Secondary	0-120h No Nausea Rate	The ratio of patients who have no nausea during the whole observation period.	24 hours, 48 hours, 72 hours, 96 hours, 120 hours after chemotherapy