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Aprepitant Without Steroid in Preventing Chemotherapy-induced Nausea and Vomiting in Patients With Colorectal Cancer

Primary Purpose

Chemotherapy-induced Nausea and Vomiting, Colorectal Cancer

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Aprepitant+Tropisetron

Dexamethasone+Tropisetron

About this trial

This is an interventional supportive care trial for Chemotherapy-induced Nausea and Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of colorectal cancer
No prior chemotherapy and scheduled to receive FOLFOX chemotherapy (oxaliplatin,leucovorin and 5-fluorouracil)
Age ≥18 years
Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
Laboratory index: Hemoglobin ≥ 90 g/L (No blood transfusion within 14 days), Absolute Neutrophil Count ≥ 1.5×10^9/L, Platelet Count ≥ 75×10^9/L, Serum Bilirubin ≤ 1.5×ULN, ALT and AST ≤ 3.0×ULN (without liver metastases), ALT and AST ≤ 5.0×ULN (with liver metastases), Serum Creatinine ≤ 1×ULN, Endogenous Creatinine Clearance>60ml/min
Be able to read, understand and complete the questionnaire and diary
Be able to understand the study procedures and sign informed consent.

Exclusion Criteria:

Treatment with any other study medicine within 4 weeks before enrollment.
Nausea or vomiting ≤ 24 hours prior to registration
Ongoing emesis due to obstruction of digestive tract
Concurrent use of olanzapine, phenothiazine or amifostine
Female with pregnancy or lactation
Severe cognitive compromise
Known history of CNS disease (e.g. brain metastases, seizure disorder)
Concurrent abdominal radiotherapy
Chronic alcoholism
Known hypersensitivity to aprepitant, tropisetron, or dexamethasone.
Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the previous six months.
History of uncontrolled diabetes mellitus
Serious or uncontroled infection
Known active HIV, viral hepatitis or tuberculosis infections

Sites / Locations

Gastrointestinal Hospital, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aprepitant arm

Control arm

Arm Description

Aprepitant + Tropisetron

Dexamethasone+ Tropisetron

Outcomes

Primary Outcome Measures

Complete response

No emetic episodes and no use of rescue medication

Secondary Outcome Measures

Nausea score

Nausea scores measured by the Nausea and Vomiting Daily Diary/Questionnaire

Time to First Vomiting Episode or Use of Rescue Medication

Frequency of rescue medication

Patients were asked to record daily number of extra nausea/vomiting pills taken because they developed nausea/vomiting in the following categories: None, One, Two, More than two in Nausea and Vomiting Daily Diary Questionnaire

Complete response in the acute phase (0-24 hours)

No emetic episodes and no use of rescue medication in the acute phase (0-24 h)

Complete response in the delay phase (25 hours-120 hours)

No emetic episodes and no use of rescue medication in the delay phase

Full Information

NCT ID

NCT02909478

First Posted

September 19, 2016

Last Updated

July 24, 2021

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02909478

Brief Title

Aprepitant Without Steroid in Preventing Chemotherapy-induced Nausea and Vomiting in Patients With Colorectal Cancer

Official Title

Steroid-free Regimen With Aprepitant in Preventing Chemotherapy-induced Nausea and Vomiting in Patients With Colorectal Cancer Receiving FOLFOX Chemotherapy: a Randomized Phase 3 Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

September 1, 2017 (Actual)

Primary Completion Date

October 23, 2019 (Actual)

Study Completion Date

December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Addition of aprepitant, an NK1 receptor antagonist to a 5-HT3 receptor antagonist and dexamethasone regimen was shown to be effective for prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC). Little is known about the efficacy of aprepitant when used without dexamethasone. Dexamethasone is widely used to prevent both acute and delayed nausea and vomiting induced by chemotherapy. However, multi-period use of dexamethasone could be associated with side effect, such as hyperglycemia, dyspepsia and insomnia. This randomized phase III trial studies antiemetic therapy with aprepitant and tropisetron to see how well they work compared to dexamethasone plus tropisetron in preventing chemotherapy-induced nausea and vomiting in patients with colorectal cancer receiving FOLFOX(oxaliplatin, leuvovorin and 5-fluorouracil) chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chemotherapy-induced Nausea and Vomiting, Colorectal Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

315 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aprepitant arm

Arm Type

Experimental

Arm Description

Aprepitant + Tropisetron

Arm Title

Control arm

Arm Type

Active Comparator

Arm Description

Dexamethasone+ Tropisetron

Intervention Type

Drug

Intervention Name(s)

Aprepitant+Tropisetron

Intervention Description

Patients will receive the chemotherapy drugs oxaliplatin,leucovorin and 5-fluorouracil as well as the following antiemetic drugs: aprepitant (125 mg orally on day 1 and 80 mg orally on days 2 and 3) plus Tropisetron (5mg IV of day1)

Intervention Type

Drug

Intervention Name(s)

Dexamethasone+Tropisetron

Intervention Description

Patients will receive the chemotherapy drugs oxaliplatin, leucovorin and 5-fluorouracil as well as the following antiemetic drugs: Dexamethasone (10 mg IV on day 1 and 5 mg IV days 2, 3) plus Tropisetron (5mg IV of day1)

Primary Outcome Measure Information:

Title

Complete response

Description

No emetic episodes and no use of rescue medication

Time Frame

Day 1 to Day 5 after chemotherapy

Secondary Outcome Measure Information:

Title

Nausea score

Description

Nausea scores measured by the Nausea and Vomiting Daily Diary/Questionnaire

Time Frame

Day 1 to Day 5 after chemotherapy

Title

Time to First Vomiting Episode or Use of Rescue Medication

Time Frame

Day 1 to Day 5 after chemotherapy

Title

Frequency of rescue medication

Description

Time Frame

Day 1 to Day 5 after chemotherapy

Title

Complete response in the acute phase (0-24 hours)

Description

No emetic episodes and no use of rescue medication in the acute phase (0-24 h)

Time Frame

0 to 24 hours after chemotherapy

Title

Complete response in the delay phase (25 hours-120 hours)

Description

No emetic episodes and no use of rescue medication in the delay phase

Time Frame

Day 2 to Day 5 (25 hours-120 hours) after chemotherapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of colorectal cancer No prior chemotherapy and scheduled to receive FOLFOX chemotherapy (oxaliplatin,leucovorin and 5-fluorouracil) Age ≥18 years Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2 Laboratory index: Hemoglobin ≥ 90 g/L (No blood transfusion within 14 days), Absolute Neutrophil Count ≥ 1.5×10^9/L, Platelet Count ≥ 75×10^9/L, Serum Bilirubin ≤ 1.5×ULN, ALT and AST ≤ 3.0×ULN (without liver metastases), ALT and AST ≤ 5.0×ULN (with liver metastases), Serum Creatinine ≤ 1×ULN, Endogenous Creatinine Clearance>60ml/min Be able to read, understand and complete the questionnaire and diary Be able to understand the study procedures and sign informed consent. Exclusion Criteria: Treatment with any other study medicine within 4 weeks before enrollment. Nausea or vomiting ≤ 24 hours prior to registration Ongoing emesis due to obstruction of digestive tract Concurrent use of olanzapine, phenothiazine or amifostine Female with pregnancy or lactation Severe cognitive compromise Known history of CNS disease (e.g. brain metastases, seizure disorder) Concurrent abdominal radiotherapy Chronic alcoholism Known hypersensitivity to aprepitant, tropisetron, or dexamethasone. Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the previous six months. History of uncontrolled diabetes mellitus Serious or uncontroled infection Known active HIV, viral hepatitis or tuberculosis infections

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yanhong Deng, M.D.

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gastrointestinal Hospital, Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510655

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

35747189

Citation

Cheng Y, Wu Z, Shi L, Shen C, Zhang J, Hu H, Li W, Cai Y, Xie X, Ling J, Zheng Q, Deng Y. Aprepitant plus palonosetron versus dexamethasone plus palonosetron in preventing chemotherapy-induced nausea and vomiting in patients with moderate-emetogenic chemotherapy: A randomized, open-label, phase 3 trial. EClinicalMedicine. 2022 Jun 3;49:101480. doi: 10.1016/j.eclinm.2022.101480. eCollection 2022 Jul.

Results Reference

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Aprepitant Without Steroid in Preventing Chemotherapy-induced Nausea and Vomiting in Patients With Colorectal Cancer

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