Aprepitant for Nause and Vomiting Induced by Chemoradiotherapy in HNSCC

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of aprepitant combined with ondansetron and dexamethasone to prevent nausea and vomiting induced by Intensity-modulated Radiotherapy (IMRT) cisplatin-chemotherapy regimen in locally advanced squamous cell carcinoma of head and neck

Detailed Description
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To evaluate the complete response rate, nause-free rate, vomiting-free rate, and the quality of life of aprepitant combined with ondansetron and dexamethasone for the nausea and vomiting induced by chemoradiotherapy in HNSCC.

Official Title
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A Prospective, Open-label, Single-arm Study for Efficacy and Safety of Three-drug Antiemetic Regimen to Prevent the Emesis During Radiotherapy With Concurrent Chemoradiotherapy in Locally Advanced HNSCC

Conditions
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Vomiting, Nausea Post Chemotherapy, Head Neck Cancer

Intervention / Treatment
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* Drug: Aprepitant


Participation Criteria
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Eligibility Criteria
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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: Nausea and vomiting occurred 24 hours before the start of the chemotherapy; Corticosteroid or benzodiazepines used; Combination Medicine which metabolism through drug-metabolizing enzyme CPY3A4 and CYP2D6; Serious cardiovascular, pulmonary, diabetes, mental and other diseases; Perinatal women or refused to take contraception during treatment; Other induced vomiting factors. (The transfer of the central nervous system, intestinal obstruction or hypocalcemia, and so on)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aprepitant<br>Aprepitant combined with ondansetron and dexamethasone | Drug: Aprepitant<br>* Intensity-modulated radiotherapy was given to the patients with regimen of 69.96 Gy-73.92 Gy to the gross target volume of nasopharynx,69.96 Gy to the gross target volume of positive nodes, 60.06 Gy the high risk clinical target volume, 50.96 Gy to the low risk clinical target volume. Concurrent chemotherapy is administrated with cisplatin 100mg/m2 at d1, d22, d43 during radiotherapy. Patients receive concurrent aprepitant 125mg, dexamethasone 12mg, and ondansetron 8mg p.o. on day1. AND then patients received aprepitant 80mg, dexamethasone 8mg on day 2-5 at every chemotherapy cycle.<br>* Other names: Ondansetron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate | no vomiting and nausea, and no use of rescue therapy | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate | no vomiting and nausea, and no use of rescue therapy | up to 3 weeks | 
| Complete response rate | no vomiting and nausea, and no use of rescue therapy | up to 6 weeks | 
| European Organization for Research on Treatment of Cancer Quality of life questionnaire | Quality of life questionnaire core 30 chinese version is used. The total score is reported, and the high values represent a worse outcome. | up to 12 weeks |