Back to resultsAprepitant for Nause and Vomiting Induced by Chemoradiotherapy in HNSCC
Primary Purpose
Vomiting, Nausea Post Chemotherapy, Head Neck Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Aprepitant
Sponsored by
About this trial
This is an interventional treatment trial for Vomiting
Eligibility Criteria
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)
Sites / Locations
- National Cancer Center/ Cancer Hospital, Chinese Academy of Medcal science and Peking Union Medical College
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aprepitant
Arm Description
Aprepitant combined with ondansetron and dexamethasone
Outcomes
Primary Outcome Measures
Complete response rate
no vomiting and nausea, and no use of rescue therapy
Secondary Outcome Measures
Complete response rate
no vomiting and nausea, and no use of rescue therapy
Complete response rate
no vomiting and nausea, and no use of rescue therapy
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.
Full Information
NCT ID
NCT03572829
First Posted
June 7, 2018
Last Updated
July 14, 2020
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03572829
Brief Title
Aprepitant for Nause and Vomiting Induced by Chemoradiotherapy in HNSCC
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
January 9, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vomiting, Nausea Post Chemotherapy, Head Neck Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aprepitant
Arm Type
Experimental
Arm Description
Aprepitant combined with ondansetron and dexamethasone
Intervention Type
Drug
Intervention Name(s)
Aprepitant
Other Intervention Name(s)
Dexamethasone, Ondansetron
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complete response rate
Description
no vomiting and nausea, and no use of rescue therapy
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Complete response rate
Description
no vomiting and nausea, and no use of rescue therapy
Time Frame
up to 3 weeks
Title
Complete response rate
Description
no vomiting and nausea, and no use of rescue therapy
Time Frame
up to 6 weeks
Title
European Organization for Research on Treatment of Cancer Quality of life questionnaire
Description
Quality of life questionnaire core 30 chinese version is used. The total score is reported, and the high values represent a worse outcome.
Time Frame
up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junlin Yi, M.D.
Organizational Affiliation
National Cancer Center/ Cancer Hospital, Chinese Academy of Medcal science and Peking Union Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center/ Cancer Hospital, Chinese Academy of Medcal science and Peking Union Medical College
City
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Aprepitant for Nause and Vomiting Induced by Chemoradiotherapy in HNSCC
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