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Chemotherapy-induced Nausea and VomitingPhase 3NCT02909478

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

A Phase 3 study testing Aprepitant+Tropisetron and Dexamethasone+Tropisetron in people with Chemotherapy-induced Nausea and Vomiting and Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Aprepitant+Tropisetron and Dexamethasone+Tropisetron
Could I receive a placebo?
No, everyone receives an active treatment
How many people
315 participants
Where
1 siteChina
Study dates
1 Sep 2017to 31 Dec 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Gastrointestinal Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510655

Other trials in China

About this study

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

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.

Being tested
Aprepitant+Tropisetron, Dexamethasone+Tropisetron
Medical subject headings
Vomiting, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aprepitant+TropisetronDrug

    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+TropisetronDrug

    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)

Study groups in NCT02909478
Study groupRoleWhat they receive
Aprepitant armExperimentalAprepitant + Tropisetron
Receives: Drug: Aprepitant+Tropisetron
Control armActive comparatorDexamethasone+ Tropisetron
Receives: Drug: Dexamethasone+Tropisetron

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete response

    No emetic episodes and no use of rescue medication

    Measured: Day 1 to Day 5 after chemotherapy

Secondary outcomes (5)

  1. Nausea score

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

    Measured: Day 1 to Day 5 after chemotherapy

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

    Measured: Day 1 to Day 5 after chemotherapy

  3. 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

    Measured: Day 1 to Day 5 after chemotherapy

  4. 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)

    Measured: 0 to 24 hours after chemotherapy

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2016 (estimated)
  2. Study start1 Sep 2017
  3. Primary completion23 Oct 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
315 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02909478
Sponsor's protocol ID
GIHSYSU12
Status last verified
Jul 2021
First submitted
19 Sep 2016
Last updated
29 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35747189

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aprepitant+Tropisetron and Dexamethasone+Tropisetron in people with Chemotherapy-induced Nausea and Vomiting and Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response (time frame: Day 1 to Day 5 after chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02909478, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.

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