Aprepitant for Nause and Vomiting Induced by Chemoradiotherapy in HNSCC

Phase 2

Completed

• Conditions: Head Neck Cancer; Vomiting; Nausea Post Chemotherapy
• Interventions: Drug: Aprepitant

• Registration Number: NCT03572829
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-06-07
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-28
• Primary Completion: 2020-01-09
• Status Verified: 2020-07
• Study Completion: 2020-07-01
• Last Update Submitted: 2020-07-14
• Last Update Posted: 2020-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aprepitant	Aprepitant	Aprepitant combined with ondansetron and dexamethasone

Primary Outcome Measures

Name	Time	Method
Complete response rate	up to 8 weeks	no vomiting and nausea, and no use of rescue therapy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Cancer Center/ Cancer Hospital, Chinese Academy of Medcal science and Peking Union Medical College; 🇨🇳 Beijing, China