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

  • End date
    Sep 21, 2023
  • participants needed
  • sponsor
    Chinese Academy of Medical Sciences
Updated on 21 March 2022


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.


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..

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


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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note