Olanzapine and 5-HT3 With or Without Dexamethasone to Prevent CINV

NCT05805800 | Completed Phase 3 DMC

• 1 other identifier: 2023-157
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

Brief Summary

Nausea and vomiting caused by chemotherapy are considered by patients as the main side effects of cancer treatment, which affect the quality of treatment and life.At present, NCCN guidelines have recommended three or four drug regimens for highly emetic chemotherapy (HEC) to prevent vomiting, all containing dexamethasone.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.For certain patients, the use of dexamethasone should be avoided.Analysis shows that olanzapine can replace the effect of dexamethasone.Hence, the investigators initiated this prospective, multi-center, phase III study to validate the dexamethasone-free protocol: removing dexamethasone from a three drug regimen containing olanzapine, dexamethasone, and 5-HT3RA.

Conditions

Chemotherapy-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 25-120 hours Complete Remission Rate

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

• 0-120h No Nausea Rate

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

Study Arms (2)

5HT3RA+Olanzapine

EXPERIMENTAL

Using one of the 5-HT3 receptor antagonists within 30 minutes before cisplatin/adriamycin/cyclophosphamide.On day 1-4, Olanzapine is delivered orally after dinner.

Drug: 5HT3RA+Olanzapine

5HT3RA+Olanzapine+Dexamethasone

ACTIVE COMPARATOR

Using one of the 5-HT3 receptor antagonists within 30 minutes before cisplatin/adriamycin/cyclophosphamide.On day 1-4, Olanzapine is delivered orally after dinner.On first day, dexamethasone is given orally within 30 minutes before cisplatin/adriamycin/cyclophosphamide administered.

Drug: 5HT3RA+Olanzapine+Dexamethasone

Interventions

5HT3RA+Olanzapine DRUG

Using one of the 5-HT3 receptor antagonists within 30 minutes before cisplatin/adriamycin/cyclophosphamide. On day 1-4, Olanzapine is delivered orally after dinner.

5HT3RA+Olanzapine

5HT3RA+Olanzapine+Dexamethasone DRUG

Using one of the 5-HT3 receptor antagonists within 30 minutes before cisplatin/adriamycin/cyclophosphamide. On day 1-4, Olanzapine is delivered orally after dinner. On first day, dexamethasone is given orally within 30 minutes before cisplatin/adriamycin/cyclophosphamide administered.

5HT3RA+Olanzapine+Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older with malignant disease；
• Life expectancy ≥ 3 months;
• Scheduled to receive highly emetogenic chemotherapy；
• Had a European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

You may not qualify if:

• There are contraindications to chemotherapy(Absolute number of neutrophils ≤ 1,500/uL, hemoglobin ≤ 90g/L, platelet count ≤ 10000/uL, serum creatinine level ≥ 2.0mg/dl (177 μmol/L), ALT and AST ≥ 2.5 times the upper normal limit, bilirubin ≥ 1.5 times the upper normal limit);
• History of central nervous system disease (e.g., brain metastases or a seizure disorder);
• Severe cognitive impairment；
• Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment or plans for such treatment during the study period;
• Concurrent use of pharyngeal or abdominal radiotherapy;
• Concurrent use of quinolone antibiotics;
• Concurrent use of Amifostine;
• 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;
• Patients who require medication with dexamethasone for pretreatment.

Sponsors & Collaborators

• Xingchen Peng: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (7)

• Ng TL, Hutton B, Clemons M. Chemotherapy-Induced Nausea and Vomiting: Time for More Emphasis on Nausea? Oncologist. 2015 Jun;20(6):576-83. doi: 10.1634/theoncologist.2014-0438. Epub 2015 May 6.

  PMID: 25948677 BACKGROUND

• Yang LQ, Sun XC, Qin SK, Cheng Y, Shi JH, Chen ZD, Wang QM, Zhang HL, Hu B, Liu B, Zhang QY, Wu Q, Wang D, Shu YQ, Dong J, Han BH, Wang KM, Dang CX, Li JL, Wang HB, Li BL, Lu JG, Zhang ZH, Chen YX. Efficacy and safety of fosaprepitant in the prevention of nausea and vomiting following highly emetogenic chemotherapy in Chinese people: A randomized, double-blind, phase III study. Eur J Cancer Care (Engl). 2017 Nov;26(6):e12668. doi: 10.1111/ecc.12668. Epub 2017 Apr 10.

  PMID: 28393417 BACKGROUND

• Hu Z, Cheng Y, Zhang H, Zhou C, Han B, Zhang Y, Huang C, Chang J, Song X, Liang J, Liang H, Bai C, Yu S, Chen J, Wang J, Pan H, Chitkara DK, Hille DA, Zhang L. Aprepitant triple therapy for the prevention of chemotherapy-induced nausea and vomiting following high-dose cisplatin in Chinese patients: a randomized, double-blind, placebo-controlled phase III trial. Support Care Cancer. 2014 Apr;22(4):979-87. doi: 10.1007/s00520-013-2043-9. Epub 2013 Nov 26.

  PMID: 24276953 BACKGROUND

• Tan L, Liu J, Liu X, Chen J, Yan Z, Yang H, Zhang D. Clinical research of Olanzapine for prevention of chemotherapy-induced nausea and vomiting. J Exp Clin Cancer Res. 2009 Sep 23;28(1):131. doi: 10.1186/1756-9966-28-131.

  PMID: 19775450 BACKGROUND

• Navari RM, Qin R, Ruddy KJ, Liu H, Powell SF, Bajaj M, Dietrich L, Biggs D, Lafky JM, Loprinzi CL. Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting. N Engl J Med. 2016 Jul 14;375(2):134-42. doi: 10.1056/NEJMoa1515725.

  PMID: 27410922 BACKGROUND

• Chelkeba L, Gidey K, Mamo A, Yohannes B, Matso T, Melaku T. Olanzapine for chemotherapy-induced nausea and vomiting: systematic review and meta-analysis. Pharm Pract (Granada). 2017 Jan-Mar;15(1):877. doi: 10.18549/PharmPract.2017.01.877. Epub 2017 Mar 15.

  PMID: 28503222 BACKGROUND

• Chen S, Pei YY, Zhang HW, Chen Y, Deng LC, Chen X, Wei ZG, Li D, Li ZH, Li RD, Liu ZR, Peng XC. Randomized, double-blind phase III trial of a dexamethasone-free regimen for managing highly emetogenic chemotherapy-induced nausea and vomiting. Int J Cancer. 2026 Jan 1;158(1):131-139. doi: 10.1002/ijc.70069. Epub 2025 Jul 30.

  PMID: 40735921 DERIVED

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D,Professor

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 10, 2023
• Study Start: April 15, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 15, 2024
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)