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

NCT02909478 | Completed Phase 3

• 1 other identifier: GIHSYSU12
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Nausea and Vomiting; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Complete response

  No emetic episodes and no use of rescue medication

  Day 1 to Day 5 after chemotherapy

Secondary Outcomes (5)

• Nausea score

  Day 1 to Day 5 after chemotherapy

• Time to First Vomiting Episode or Use of Rescue Medication

  Day 1 to Day 5 after chemotherapy

• Frequency of rescue medication

  Day 1 to Day 5 after chemotherapy

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

  0 to 24 hours after chemotherapy

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

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

Study Arms (2)

Aprepitant arm

EXPERIMENTAL

Aprepitant + Tropisetron

Drug: Aprepitant+Tropisetron

Control arm

ACTIVE COMPARATOR

Dexamethasone+ Tropisetron

Drug: Dexamethasone+Tropisetron

Interventions

Aprepitant+Tropisetron DRUG

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)

Aprepitant arm

Dexamethasone+Tropisetron DRUG

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)

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Gastrointestinal Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

Related Publications (1)

• 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.

  PMID: 35747189 DERIVED

MeSH Terms

Conditions

Vomiting; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Yanhong Deng, M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: September 21, 2016
• Study Start: September 1, 2017
• Primary Completion: October 23, 2019
• Study Completion: December 31, 2019
• Last Updated: July 29, 2021

Record last verified: 2021-07

Locations

CN (1)