Status:
UNKNOWN
The Optimization of Antiemetic Regimen for C-RINV in LA-HNSCCs
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Nausea
Vomiting
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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-...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT05202275
Start Date
December 1 2020
End Date
September 1 2023
Last Update
January 21 2022
Active Locations (1)
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1
Ye Zhang
Beijing, Beijing Municipality, China, 100020