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Completed

NCT Number: NCT04437017

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fifth Affilliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Olanzapine+NK-1 RA+5-HT3 RA

Drug

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

Dexamethasone+NK-1 RA+5-HT3 RA

Drug

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.

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

Primary outcomes

  1. 0-120h Complete Remission Rate

    Time frame: 24 hours ,48 hours, 72 hours, 96 hours, 120 hours after chemotherapy

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

Secondary outcomes

  1. 25-120 hours Complete Remission Rate

    Time frame: 24 hours , 48 hours, 72 hours, 96 hours, 120 hours after chemotherapy

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

  2. 0-120h No Nausea Rate

    Time frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours after chemotherapy

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

Sponsors and collaborators

Lead sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 18, 2020
Registry last updated
Jul 29, 2022

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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