Olanzapine for the Prevention and Treatment of Nausea and Vomiting Induced by Chemotherapy of Lung Cancer
Status:
Recruiting
Trial end date:
2023-08-01
Target enrollment:
Participant gender:
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: ⑴
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; ⑵ Chemotherapeutic agents and
the metabolites of them activate chemoreceptors directly, which causes vomiting. ⑶ 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: ⑴ Aprepitant is expensive and not covered in medical care
in China, which limits the application in patients. ⑵There 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.
Phase:
Phase 4
Details
Lead Sponsor:
Zunyi Medical College
Collaborators:
Affiliated Hospital of North Sichuan Medical College Affiliated Hospital of Southwest Medical University Guizhou Provincial People's Hospital Sichuan Cancer Hospital and Research Institute The First Hospital of Quanzhou Affiliated to Fujian Medical University The First People’s Hospital of Zunyi Zunyi First People's Hospital