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Chemotherapy-induced Nausea and VomitingPhase 3NCT04437017

Olanzapine or Dexamethasone, With 5-HT3 RA and NK-1 RA, to Prevent CINV

A Phase 3 study testing Olanzapine+NK-1 RA+5-HT3 RA and Dexamethasone+NK-1 RA+5-HT3 RA in people with Chemotherapy-induced Nausea and Vomiting, run by Fifth Affiliated Hospital, 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

Chemotherapy-induced nausea and vomiting is a common side effect of cancer treatments, and dexamethasone offers a clear advantage over placebo for protection against chemotherapy-induced emesis in both acute and delayed phases. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chemotherapy-induced Nausea and Vomiting
What is being tested?
Olanzapine+NK-1 RA+5-HT3 RA and Dexamethasone+NK-1 RA+5-HT3 RA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
557 participants
Where
1 siteChina
Study dates
3 Feb 2020to 1 Jul 2022
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria (Patients are eligible to be included in the study only if they meet all of the following criteria):

  1. Cancer patients, age ≥ 18 years and ≤75 years, ECOG score 0-2 points, receiving cisplatin-containing doublet chemotherapy such as cisplatin + gemcitabine / albumin paclitaxel / etoposide /fluorouracil / irinotecan / temozolomide as first line treatment;
  2. Life expectancy ≥ 3 months;
  3. Leucocytes≥3,000/uL;
  4. AST≤2.5 × upper limit of normal;
  5. Bilirubin ≤1.5 × upper limit of normal;
  6. Serum creatinine ≤ 1.5 × upper limit of normal.

Exclusion Criteria (Patients will be excluded if any of the following criteria is met):

  1. History of CNS disease, such as brain metastases or epilepsy;
  2. Use of other antipsychotic drugs (such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone, or such treatment is under scheduling during the study) within 30 days before enrollment; long-term use of phenothiazine as an antipsychotic agent;
  3. Concurrent use of pharyngeal or abdominal radiotherapy;
  4. Concurrent use of quinolone antibiotics;
  5. Chronic alcoholism;
  6. Known hypersensitivity to olanzapine;
  7. Know arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within 6 months;
  8. Known uncontrolled diabetes mellitus;
  9. Vomiting or retching 24 hours before chemotherapy;
  10. Use of anti-emesis drugs 48 hours before chemotherapy;
  11. Concurrent use of amifostine;
  12. Concurrent use of corticosteroids and the only anti-allergic choice is corticosteroids

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fifth Affilliated Hospital of Sun Yat-sen University

    Zhuhai, Guangdong

Other trials in China

About this study

Official title: Olanzapine or Dexamethasone, With 5-HT3 RA and NK-1 RA, to Prevent Nausea and Vomiting Induced by Cisplatin-Based Doublet Chemotherapy: A Non-inferiority, Prospective, Multi-Centered, Randomized, Controlled, Phase III Clinical Trial

Chemotherapy-induced nausea and vomiting is a common side effect of cancer treatments, and dexamethasone offers a clear advantage over placebo for protection against chemotherapy-induced emesis in both acute and delayed phases. However, its side effects such as moderate to severe insomnia, hyperglycemia, dyspepsia, upper abdominal discomfort, irritability, increased appetite, weight gain and acne are gathering increasing concerns. Several clinical trials have shown that olanzapine plays an important role in treating delayed, refractory, breakthrough nausea and vomiting. Its side effects mainly include sedation and weight gaining. At present, the NCCN guidelines have recommended olanzapine-containing three-drug regimen for Highly Emetogenic Chemotherapy (HEC) and moderate emetic chemotherapy (MEC) to prevent vomiting, but its data in the Chinese population is limited. Hence, we initiated this prospective, multi-center, phase III study to validate the dexamethasone-free protocol: applying olanzapine to prevent CINV instead of dexamethasone.

Being tested
Olanzapine+NK-1 RA+5-HT3 RA, Dexamethasone+NK-1 RA+5-HT3 RA
Keywords
nausea, vomiting, antiemesis
Medical subject headings
Vomiting, Nausea

What participants receive

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

  • Olanzapine+NK-1 RA+5-HT3 RADrug

    On day 1-4, Olanzapine (5mg) is delivered orally after dinner.

  • Dexamethasone+NK-1 RA+5-HT3 RADrug

    Also called Acidocont, Deronil, Dexacortal, Desameton

    On first day, dexamethasone (12 mg) is given orally/intravenously within 30 minutes before cisplatin administrated, and on day 2-4, the given dose of dexamethasone is 8 mg.

Study groups in NCT04437017
Study groupRoleWhat they receive
Olanzapine+NK-1 RA+5-HT3 RAExperimentalUsing one of the 5-HT3 receptor antagonists (a. Palonosetron: 0.25 mg d1 intravenous; b. Granisetron: 1 mg d1 intravenously, or 2 mg d1 orally; c. Ondansetron: 8-16 mg d1 intravenous or oral. the specific agent is chosen by the primary clinician, and is only delivered on the first day) within 30 minutes before cisplatin. Using one of the NK-1 receptor antagonists(a. Aprepitant: 125 mg orally, d1, 80 mg orally, d2-3; b. Fosaprepitant: 150 mg intravenously, d1) within 1 hour before cisplatin. On day 1-4, Olanzapine (5mg) is delivered orally after dinner.
Receives: Drug: Olanzapine+NK-1 RA+5-HT3 RA
Dexamethasone+NK-1 RA+5-HT3 RAActive comparatorUsing one of the 5-HT3 receptor antagonists (a. Palonosetron: 0.25 mg d1 intravenous; b. Granisetron: 1 mg d1 intravenously, or 2 mg d1 orally; c. Ondansetron: 8-16 mg d1 intravenous or oral. the specific agent is chosen by the primary clinician, and is only delivered on the first day) within 30 minutes before cisplatin. Using one of the NK-1 receptor antagonists (a. Aprepitant: 125 mg orally, d1, 80 mg orally, d2-3; b. Fosaprepitant: 150 mg intravenously, d1) within 1 hour before cisplatin. On first day, dexamethasone (12 mg) is given orally/intravenously within 30 minutes before cisplatin administered, and on day 2-4, the given dose of dexamethasone is 8 mg.
Receives: Drug: Dexamethasone+NK-1 RA+5-HT3 RA

What is being measured

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

  1. 0-120h Complete Remission Rate

    The ratio of patients who have no vomiting and apply no anti-nausea drugs during the whole observation period.

    Measured: 24 hours ,48 hours, 72 hours, 96 hours, 120 hours after chemotherapy

Secondary outcomes (2)

  1. 25-120 hours Complete Remission Rate

    The ratio of patients who have no vomiting and apply no anti-nausea drugs during the 25-120 hours observation period.

    Measured: 24 hours , 48 hours, 72 hours, 96 hours, 120 hours after chemotherapy

  2. 0-120h No Nausea Rate

    The ratio of patients who have no nausea during the whole observation period.

    Measured: 24 hours, 48 hours, 72 hours, 96 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 posted18 Jun 2020
  2. Study start3 Feb 2020
  3. Primary completion1 May 2022
  4. Study completion1 Jul 2022

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
557 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04437017
Sponsor's protocol ID
No.ZDWY[2020]LunziNo.(K01-1)
Status last verified
May 2021
First submitted
16 Jun 2020
Last updated
29 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Olanzapine+NK-1 RA+5-HT3 RA and Dexamethasone+NK-1 RA+5-HT3 RA in people with Chemotherapy-induced Nausea and Vomiting, run by Fifth Affiliated Hospital, 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?

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 2022. 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?

0-120h Complete Remission Rate (time frame: 24 hours ,48 hours, 72 hours, 96 hours, 120 hours 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 NCT04437017.

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 2022.

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