The Optimization of Antiemetic Regimen for C-RINV in LA-HNSCCs

  • STATUS
    Recruiting
  • End date
    Sep 21, 2023
  • participants needed
    43
  • sponsor
    Chinese Academy of Medical Sciences
Updated on 21 March 2022
nausea
carcinoma
cavity
aprepitant
olanzapine
palonosetron

Summary

This study sought to investigate the efficacy and safety of a three-drug combination antiemetic regimen of olanzapine combined with aprepitant and palonosetron for the prevention of chemoradiotherapy-induced nausea and vomiting in locally advanced head and neck squamous cell carcinoma.

Description

Intensity modulated radiotherapy (IMRT) combined with high-dose cisplatin is the standard treatment for locally advanced head and neck squamous cell carcinoma. Previous clinical studies of concurrent chemoradiotherapy have shown that the incidence of nausea and vomiting after treatment with 5-HT3RA and dexamethasone is about 40%. Nausea and vomiting seriously affect the patient's treatment tolerance and quality of life. In our previous prospective phase 2 study (NCT03572829), the triple antiemetic regimen of NK-1R antagonist (aprepitant), dexamethasone and ondansetron was firstly used in patients with head and neck squamous cell carcinoma who received concurrent chemoradiotherapy. the primary endpoint-complete response rate was 86%, and the incidence of no vomiting was 88.4%, which was better than the data previously reported in the literatures. The incidence of no nausea was only 60.5%, and the hiccup caused by dexamethasone was as high as 16%. And with the confirmation of the efficacy of immunotherapy in head and neck squamous cell carcinoma, the use of dexamethasone may reduce immunotherapy. Therefore, it is necessary to further optimize the antiemetic regimen. In recent years, a number of randomized studies have confirmed that the addition of olanzapine can reduce the incidence of nausea and increase the complete response rate of high emetic chemotherapy. Other randomized studies have shown that in patients with malignant tumors (including head and neck squamous cell carcinoma and esophageal cancer) receiving concurrent chemoradiotherapy, the NK-1R antagonist was changed to olanzapine on the basis of the original triple regimen, which significantly redeced the incidence of nausea.

Therefore, on the basis of previous studies, this study intends to conduct a prospective, single-arm phase II study to explore the efficacy and safety of olanzapine combined with aprepitant and palonosetron in the prevention of nausea and vomiting in patients with locally advanced head and neck squamous cell carcinoma receiving IMRT and concurrent chemotherapy..

Details
Condition Nausea, Vomiting, Head and Neck Squamous Cell Carcinoma, Radiotherapy Side Effect
Treatment olanzapine
Clinical Study IdentifierNCT05202275
SponsorChinese Academy of Medical Sciences
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Pathology confirmed squamous cell carcinoma. The primary sites included nasopharynx, mouth
oropharynx, hypopharynx, larynx, nasal cavity and paranasal sinuses Aged 18 to 70 years old
Stage III-IVB diseases Eastern Cooperative Oncology Group Performance Status 0-1 Normally
functioning of liver, kidney, bone marrow Concurrent chemoradiotherapy is recommended after
multi-disciplinary team discussion; Must be able to swallow tablets At least 12 weeks
lifetime was expected; Fertile male or female patients volunteered to use effective
contraception within 90 days of the study period and at the end of study

Exclusion Criteria

Other medical histories of malignancy apart from non-melanoma skin cancer, cervical
carcinoma in situ, and early-stage cured prostate cancer Nausea and emesis occurred 24
hours before the start of CCRT Any medicine which affected metabolism through
drug-metabolising enzymes CPY3A4 and CYP2D6 except for nighttime sedatives Mental and
severe cognitive impairment Perinatal women or rejection of taking contraception during
treatment Drug and/or alcohol addiction Symptomatic brain metastasis Gastrointestinal
obstruction Hypocalcemia or any other conditions that could provoke emesis Treatment with
another antipsychotic agent for 30 days before or during protocol therapy Concurrent chest
or abdominal radiotherapy Concurrent use of corticosteroid or amifostine or quinolone
antibiotic therapy Known hypersensitivity to olanzapine Known uncontrolled cardiac
arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within
the previous 6 months Medical history of diabetic ketoacidosis or uncontrolled diabetes
mellitus, prostate enlargement, narrow angle glaucoma
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