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The Optimization of Antiemetic Regimen for C-RINV in LA-HNSCCs

Primary Purpose

Nausea, Vomiting, Head and Neck Squamous Cell Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Olanzapine
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nausea focused on measuring Chemoradiotherapy; nausea; vomiting; Antiemetic regimen

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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:

Other medical histories of malignancy apart from non-melanoma skin cancer, cervical carcinoma in situ, and early-stage cured prostate cancer Nausea and emesis occurred 24 hours before the start of CCRT Any medicine which affected metabolism through drug-metabolising enzymes CPY3A4 and CYP2D6 except for nighttime sedatives Mental and severe cognitive impairment Perinatal women or rejection of taking contraception during treatment Drug and/or alcohol addiction Symptomatic brain metastasis Gastrointestinal obstruction Hypocalcemia or any other conditions that could provoke emesis Treatment with another antipsychotic agent for 30 days before or during protocol therapy Concurrent chest or abdominal radiotherapy Concurrent use of corticosteroid or amifostine or quinolone antibiotic therapy Known hypersensitivity to olanzapine Known uncontrolled cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous 6 months Medical history of diabetic ketoacidosis or uncontrolled diabetes mellitus, prostate enlargement, narrow angle glaucoma

Sites / Locations

  • Ye ZhangRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OPA regimen

Arm Description

All patients were given orally olanzapine 10mg once on d1-5; intravenously palonosetron 0.25mg once on d1; aprepitant 125 mg once on d1, then 80mg once on d2-5.

Outcomes

Primary Outcome Measures

Nausea-free response rate
The percentage of patients with no nausea (Visual Analogue Scale score 0) during concurrent chemotherapy.

Secondary Outcome Measures

Emesis-free response rate
The percentage of patients with no emetic episodes during concurrent chemotherapy.
Complete response rate
The percentage of patients with no emetic episodes and no use of rescue medication during concurrent chemotherapy.
Complete protection rate
The percentage of patients with no emetic episodes, no use of rescue medication and significant nausea (Visual Analogue Scale score ≤25【0-100mm】)
The rate of no significant nausea
The percentage of patients with no significant nausea (Visual Analogue Scale score ≤25【0-100mm】)

Full Information

First Posted
December 20, 2021
Last Updated
January 8, 2022
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05202275
Brief Title
The Optimization of Antiemetic Regimen for C-RINV in LA-HNSCCs
Official Title
The Optimization of Antiemetic Regimen for Chemoradiotherapy-induced Nausea and Vomiting (C-RINV) in Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCCs): A Prospective Phase Ⅱ Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study sought to investigate the efficacy and safety of a three-drug combination antiemetic regimen of olanzapine combined with aprepitant and palonosetron for the prevention of chemoradiotherapy-induced nausea and vomiting in locally advanced head and neck squamous cell carcinoma.
Detailed Description
Intensity modulated radiotherapy (IMRT) combined with high-dose cisplatin is the standard treatment for locally advanced head and neck squamous cell carcinoma. Previous clinical studies of concurrent chemoradiotherapy have shown that the incidence of nausea and vomiting after treatment with 5-HT3RA and dexamethasone is about 40%. Nausea and vomiting seriously affect the patient's treatment tolerance and quality of life. In our previous prospective phase 2 study (NCT03572829), the triple antiemetic regimen of NK-1R antagonist (aprepitant), dexamethasone and ondansetron was firstly used in patients with head and neck squamous cell carcinoma who received concurrent chemoradiotherapy. the primary endpoint-complete response rate was 86%, and the incidence of no vomiting was 88.4%, which was better than the data previously reported in the literatures. The incidence of no nausea was only 60.5%, and the hiccup caused by dexamethasone was as high as 16%. And with the confirmation of the efficacy of immunotherapy in head and neck squamous cell carcinoma, the use of dexamethasone may reduce immunotherapy. Therefore, it is necessary to further optimize the antiemetic regimen. In recent years, a number of randomized studies have confirmed that the addition of olanzapine can reduce the incidence of nausea and increase the complete response rate of high emetic chemotherapy. Other randomized studies have shown that in patients with malignant tumors (including head and neck squamous cell carcinoma and esophageal cancer) receiving concurrent chemoradiotherapy, the NK-1R antagonist was changed to olanzapine on the basis of the original triple regimen, which significantly redeced the incidence of nausea. Therefore, on the basis of previous studies, this study intends to conduct a prospective, single-arm phase II study to explore the efficacy and safety of olanzapine combined with aprepitant and palonosetron in the prevention of nausea and vomiting in patients with locally advanced head and neck squamous cell carcinoma receiving IMRT and concurrent chemotherapy..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting, Head and Neck Squamous Cell Carcinoma, Radiotherapy Side Effect
Keywords
Chemoradiotherapy; nausea; vomiting; Antiemetic regimen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OPA regimen
Arm Type
Experimental
Arm Description
All patients were given orally olanzapine 10mg once on d1-5; intravenously palonosetron 0.25mg once on d1; aprepitant 125 mg once on d1, then 80mg once on d2-5.
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
Palonosetron, Aprepitant
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. All patients were given orally olanzapine 10mg once on d1-5; intravenously palonosetron 0.25mg once on d1; aprepitant 125 mg once on d1, then 80mg once on d2-5 at every chemotherapy cycle.
Primary Outcome Measure Information:
Title
Nausea-free response rate
Description
The percentage of patients with no nausea (Visual Analogue Scale score 0) during concurrent chemotherapy.
Time Frame
Up to 6.5 weeks
Secondary Outcome Measure Information:
Title
Emesis-free response rate
Description
The percentage of patients with no emetic episodes during concurrent chemotherapy.
Time Frame
Up to 6.5 weeks
Title
Complete response rate
Description
The percentage of patients with no emetic episodes and no use of rescue medication during concurrent chemotherapy.
Time Frame
Up to 6.5 weeks
Title
Complete protection rate
Description
The percentage of patients with no emetic episodes, no use of rescue medication and significant nausea (Visual Analogue Scale score ≤25【0-100mm】)
Time Frame
Up to 6.5 weeks
Title
The rate of no significant nausea
Description
The percentage of patients with no significant nausea (Visual Analogue Scale score ≤25【0-100mm】)
Time Frame
Up to 6.5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 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: Other medical histories of malignancy apart from non-melanoma skin cancer, cervical carcinoma in situ, and early-stage cured prostate cancer Nausea and emesis occurred 24 hours before the start of CCRT Any medicine which affected metabolism through drug-metabolising enzymes CPY3A4 and CYP2D6 except for nighttime sedatives Mental and severe cognitive impairment Perinatal women or rejection of taking contraception during treatment Drug and/or alcohol addiction Symptomatic brain metastasis Gastrointestinal obstruction Hypocalcemia or any other conditions that could provoke emesis Treatment with another antipsychotic agent for 30 days before or during protocol therapy Concurrent chest or abdominal radiotherapy Concurrent use of corticosteroid or amifostine or quinolone antibiotic therapy Known hypersensitivity to olanzapine Known uncontrolled cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous 6 months Medical history of diabetic ketoacidosis or uncontrolled diabetes mellitus, prostate enlargement, narrow angle glaucoma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zekun Wang, MD
Phone
+8618710221130
Email
dr_wangzk@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ye Zhang, MD
Phone
+8613717635880
Email
drzye1983@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ye Zhang, MD
Organizational Affiliation
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ye Zhang
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ye Zhang, MD
Phone
+8613717635880
Email
drzye1983@163.com

12. IPD Sharing Statement

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The Optimization of Antiemetic Regimen for C-RINV in LA-HNSCCs

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