Olanzapine for the Prevention and Treatment of Nausea and Vomiting Induced by Chemotherapy of Lung Cancer

  • STATUS
    Recruiting
  • End date
    Aug 1, 2023
  • participants needed
    156
  • sponsor
    Zunyi Medical College
Updated on 18 July 2021
nausea
cancer
total bilirubin
absolute neutrophil count
anxiety
fatigue
lung cancer
dexamethasone
hyperglycemia
metastasis
neutrophil count
carboplatin
liver metastasis
cancer chemotherapy
antineoplastic agents
antineoplastic
aprepitant
olanzapine
adverse effect
emetic
lung carcinoma

Summary

Chemotherapy induced nausea and vomiting (CINV) is a common adverse effect in treatment of cancer, which influences the quality of life and adherence to treatment of patients and leads to dehydration, malnutrition and even death. Prevention and relieving the CINV is an important step to ensure the conduction of chemotherapy. Mechanism of CINV remains to be obscure, while most studies showed that it is mainly related to the following respects: Chemotherapeutic agents stimulate gastrointestinal tract, which induces the release of neurotransmitters by chromaffin cells. Neurotransmitters bind to corresponding receptors, and then results in vomiting by stimulating the vomiting center; Chemotherapeutic agents and the metabolites of them activate chemoreceptors directly, which causes vomiting. Feeling and mental factors irritate cerebral cortex pathway directly. There are studies suggested that 5- hydroxytryptamine (5-HT) was related to acute nausea and vomiting induced by chemotherapy, which means 5-HT receptor antagonist would be a effective medicine for acute CINV. In addition, there are researches proclaimed that neurokinin-1 (NK-1) receptor antagonist, aprepitant, is a potent agent to relieve CINV. Thus, correlative guidelines recommend regimens with 5-HT receptor antagonist, NK-1 receptor antagonist and glucocorticoid as the standard treatment for strongly emetic chemotherapy regimens. But the prevention of moderately emetic chemotherapy regimens remains to be a problem in clinical practice. Besides, there is no study to demonstrate differences of mechanisms between acute CINV and delayed CINV. Olanzapine inhibits kinds of neurotransmitters which cause CINV, it is why this medicine is effective in both acute and delayed CINV. It can also alleviate anxiety, improve sleep quality and relieve pain in patients with cancer. The most common adverse effects of olanzapine are lethargy, body mass increase, fatigue, dry mouth, constipation, hyperlipidemia and hyperglycemia. Among them, the most common one is lethargy, which can oppose insomnia and excitation caused by dexamethasone. In a word, olanzapine is an agent with mild adverse effects, it is worth to be generalized. But there are still problems to be resolved in the application of olanzapine in CINV: Aprepitant is expensive and not covered in medical care in China, which limits the application in patients. There is no large clinical trial to confirm the efficacy and safety of olanzapine in Chinese populations. To explore these issues better, investigators intend to compare the regimen with olanzapine, dexamethasone and 5-HT receptor antagonists with the regimen with placebo, dexamethasone and 5-HT receptor antagonists about the efficacy and adverse events in treatment of CINV. Investigators aim to provide an available therapeutic options for CINV, improve the quality of life and prolong the survival of patients with lung cancer.

Details
Condition Pulmonary Disease, Lung Neoplasm, Bronchial Neoplasm, Lung Cancer, Lung Disease, Chemotherapy-induced Nausea and Vomiting, Chemotherapy-induced Nausea and Vomiting, Chemotherapy-induced Nausea and Vomiting, Chemotherapy-induced Nausea and Vomiting, carcinoma lung, lung carcinoma, Chemotherapy-induced Nausea and Vomiting, Chemotherapy-induced Nausea and Vomiting, Chemotherapy-induced Nausea and Vomiting
Treatment olanzapine, placebos
Clinical Study IdentifierNCT03571126
SponsorZunyi Medical College
Last Modified on18 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) Performance Status2 or Karnofsky performance statu (KPS) scores60
Patients with cytologically or histologically confirmed lung cancer
Patients who are willing to receive chemotherapy and can tolerate at least 2 cycles chemotherapy
Chemotherapy regimens accord with standard regimens recommended by clinical practice guidelines (National Comprehensive Cancer Network guidelines and Chinese Society of Clinical Oncology guidelines of lung cancer)
There is at least one kind of high emetic risk chemotherapy agent, mainly including regimens contain cisplatin or carboplatin (AUC4)
Adequate organ function including the following: Adequate bone marrow reserve: white blood cell (WBC) count superior or equal to 2.010^9/L , absolute neutrophil count (ANC) superior or equal to 1.510^9/L, platelets superior or equal to 8010^9/L, and hemoglobin superior or equal to 90g/L; Hepatic: bilirubin <1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and alanine transaminase (ALT) 2.5ULN (or <5ULN with liver metastases); Renal: Serum creatinine1ULN, calculated creatinine clearance (CrCl) superior or equal to 50 milliliter/min based on the standard Cockcroft and Gault formula
At least 3 weeks after the end of the last chemotherapy
Women of reproductive years are willing to contracept in appropriate methods in the period of trial and in the 8 weeks after the last administration. Doing pregnancy test before the beginning of this trial when necessary, and results of which need to be negative

Exclusion Criteria

Women who are pregnant or breastfeeding
Need to undergo radiotherapy during this trial
Patients with alimentary tract obstruction
Patients with severe heart disease, renal and liver disease and metabolic abnormalities
Patients with epilepsy or who are using antipsychotics
Patients who have been administrated with antiemetic in 24 hours or who have suffered vomiting before chemotherapy
Patients with brain metastases
Patients with contraindications of chemotherapy
Patients who are attending another clinical trial or will attend in 2 weeks
Patients who are considered unsuitable to be included by treating physicians
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