Aprepitant for Nause and Vomiting Induced by Chemoradiotherapy in HNSCC

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

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

Study Overview

• Status: Completed
• Conditions: Vomiting; Head Neck Cancer; Nausea Post Chemotherapy
• Intervention / Treatment: Drug: Aprepitant

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Aprepitant; Aprepitant combined with ondansetron and dexamethasone

Drug: Aprepitant; 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.; Other Names: Dexamethasone; Ondansetron

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Junlin Yi, M.D., National Cancer Center/ Cancer Hospital, Chinese Academy of Medcal science and Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): January 9, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: June 7, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 28, 2018

Study Record Updates

• Last Update Posted (Actual): July 15, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Signs and Symptoms, Digestive; Head and Neck Neoplasms; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Antipruritics; Neurokinin-1 Receptor Antagonists; Dexamethasone; Ondansetron; Aprepitant
• Other Study ID Numbers: CH-RCS-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No