Aprepitant for Nause and Vomiting Induced by Chemoradiotherapy in HNSCC

Sponsor

Chinese Academy of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT03572829

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Vomiting Nausea Post Chemotherapy Head Neck Cancer	Drug: Aprepitant	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Jan 9, 2020

Actual Study Completion Date :

Jul 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Complete response rate [up to 8 weeks]
no vomiting and nausea, and no use of rescue therapy

Secondary Outcome Measures

Complete response rate [up to 3 weeks]
no vomiting and nausea, and no use of rescue therapy
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Center/ Cancer Hospital, Chinese Academy of Medcal science and Peking Union Medical College	Beijing		China

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jun-Lin Yi, MD, Vice director of department of radiation oncology, Chinese Academy of Medical Sciences

ClinicalTrials.gov Identifier:

NCT03572829

Other Study ID Numbers:

CH-RCS-004

First Posted:

Jun 28, 2018

Last Update Posted:

Jul 15, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Head and Neck Neoplasms

Study Results

No Results Posted as of Jul 15, 2020