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Completed

NCT Number: NCT02909478

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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)

Primary outcomes

  1. Complete response

    Time frame: Day 1 to Day 5 after chemotherapy

    No emetic episodes and no use of rescue medication

Secondary outcomes

  1. Nausea score

    Time frame: Day 1 to Day 5 after chemotherapy

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

  2. Time to First Vomiting Episode or Use of Rescue Medication

    Time frame: Day 1 to Day 5 after chemotherapy

  3. Frequency of rescue medication

    Time frame: Day 1 to Day 5 after chemotherapy

    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

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

    Time frame: 0 to 24 hours after chemotherapy

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

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

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

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

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 21, 2016
Registry last updated
Jul 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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