Complete Response Rate to Chemotherapy-induced Nausea and Vomiting ProphylaxisPhase 3OLN-EMENCT04232423
Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis
A Phase 3 study testing Olanzapine 10 Mg ORAL TABLET and Olanzapine 5 Mg ORAL TABLET in people with Complete Response Rate to Chemotherapy-induced Nausea and Vomiting Prophylaxis, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
To investigate that olanzapine can reduced side effect about nausea and vomiting in women with gynecologic cancers receiving carboplatin-based regimen by using olanzapine and placebo Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Complete Response Rate to Chemotherapy-induced Nausea and Vomiting Prophylaxis
- What is being tested?
- Olanzapine 10 Mg ORAL TABLET and Olanzapine 5 Mg ORAL TABLET
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteThailand
- Study dates
- 1 Mar 2020to 30 Sep 2021
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with gynecological cancer receiving carboplatin-based chemotherapeutic regimen
- ECOG performance status 0-1
- Normal bone marrow, liver, and renal functions
- Can speak and write in Thai language
Who cannot join
- Women with nausea or vomiting prior to chemotherapeutic administration
- Pregnant women
- Women with active infection
- Women with bowel obstruction
- Women with symptomatic brain metastases
- Women who received dopamine receptor antagonists within 1 week before chemotherapeutic administration
Show all 14Show fewer
- Women who received corticosteroid within 1 week before chemotherapeutic administration
- Women with past history of chemotherapy or radiotherapy
- Women with psychiatric disorders
- Women with poor controlled diabetes mellitus
- Women who received anticonvulsant medication
- Women with history of neuroleptic malignant syndrome
- Women with history of olanzapine allergy
- Women with history of lactose intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Dosage of Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis in Women With Gynecologic Cancers Receiving Carboplatin-based Regimen : a Double-blind, Placebo-controlled, Randomized Crossover Trial
To investigate that olanzapine can reduced side effect about nausea and vomiting in women with gynecologic cancers receiving carboplatin-based regimen by using olanzapine and placebo
Read the detailed description
A double-blind, placebo-controlled, randomized crossover trial
- Being tested
- Olanzapine 10 Mg ORAL TABLET, Olanzapine 5 Mg ORAL TABLET, Placebo ORAL TABLET
- Keywords
- Olanzapine, Chemotherapy-induced nausea and vomiting, Carboplatin, Gynecologic cancer
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olanzapine 10 Mg ORAL TABLETDrug
- Olanzapine 10 mg orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1)
- Olanzapine 10 mg orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4
Olanzapine 5 Mg ORAL TABLETDrug
- Olanzapine 5 mg orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1)
- Olanzapine 5 mg orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4
Placebo ORAL TABLETDrug
- Placebo 1 tab orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1)
- Placebo 1 tab orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4
| Study group | Role | What they receive |
|---|---|---|
| OLN 0-5-10 | Experimental | Placebo tablet in chemotherapy cycle 1, olanzapine 5 mg tablet in chemotherapy cycle 2, and olanzapine 10 mg tablet in chemotherapy cycle 3 Receives: Drug: Olanzapine 10 Mg ORAL TABLET; Drug: Olanzapine 5 Mg ORAL TABLET; Drug: Placebo ORAL TABLET |
| OLN 5-10-0 | Experimental | Olanzapine 5 mg tablet in chemotherapy cycle 1, olanzapine 10 mg tablet in chemotherapy cycle 2, and placebo tablet in chemotherapy cycle 3 Receives: Drug: Olanzapine 10 Mg ORAL TABLET; Drug: Olanzapine 5 Mg ORAL TABLET; Drug: Placebo ORAL TABLET |
| OLN 10-0-5 | Experimental | Olanzapine10 tablet in chemotherapy cycle 1, placebo tablet in chemotherapy cycle 2, and olanzapine 5 mg tablet in chemotherapy cycle 3 Receives: Drug: Olanzapine 10 Mg ORAL TABLET; Drug: Olanzapine 5 Mg ORAL TABLET; Drug: Placebo ORAL TABLET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate of chemotherapy-induced nausea and vomiting prophylaxis
No breakthrough vomiting and no using rescue therapy
Measured: 5 days after chemotherapeutic administration
Secondary outcomes (4)
Episodes of vomiting
Measured: 5 days after chemotherapeutic administration
Severity of nausea
Measured: 5 days after chemotherapeutic administration
Use of rescue drug
using of rescue anti-emetic medication
Measured: 5 days after chemotherapeutic administration
Quality of life associated with nausea and vomiting measured using Functional Living Index-Emesis (FILE)
Measured: 5 days after chemotherapeutic administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Mar 2020
- Primary completion30 Jun 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete Response Rate to Chemotherapy-induced Nausea and Vomiting ProphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Model description
- A Double-Blind, Placebo-Controlled, Randomized Crossover Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232423
- Sponsor's protocol ID
- 162/2562
- Acronym
- OLN-EME
- Status last verified
- Jul 2021
- First submitted
- 14 Jan 2020
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Dosage of Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis in Women With Gynecologic Cancers Receiving Carboplatin-based Regimen : a Double-blind, Placebo-controlled, Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT04232423
- Acronym / sponsor ID
- OLN-EME / 162/2562
- Keywords
- Olanzapine, Chemotherapy-induced nausea and vomiting, Carboplatin, Gynecologic cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate that olanzapine can reduced side effect about nausea and vomiting in women with gynecologic cancers receiving carboplatin-based regimen by using olanzapine and placebo
Detailed description
A double-blind, placebo-controlled, randomized crossover trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A Double-Blind, Placebo-Controlled, Randomized Crossover Trial
| Arm | Type | Receives |
|---|---|---|
| OLN 0-5-10 | Experimental | Drug: Olanzapine 10 Mg ORAL TABLET, Drug: Olanzapine 5 Mg ORAL TABLET, Drug: Placebo ORAL TABLETPlacebo tablet in chemotherapy cycle 1, olanzapine 5 mg tablet in chemotherapy cycle 2, and olanzapine 10 mg tablet in chemotherapy cycle 3 |
| OLN 5-10-0 | Experimental | Drug: Olanzapine 10 Mg ORAL TABLET, Drug: Olanzapine 5 Mg ORAL TABLET, Drug: Placebo ORAL TABLETOlanzapine 5 mg tablet in chemotherapy cycle 1, olanzapine 10 mg tablet in chemotherapy cycle 2, and placebo tablet in chemotherapy cycle 3 |
| OLN 10-0-5 | Experimental | Drug: Olanzapine 10 Mg ORAL TABLET, Drug: Olanzapine 5 Mg ORAL TABLET, Drug: Placebo ORAL TABLETOlanzapine10 tablet in chemotherapy cycle 1, placebo tablet in chemotherapy cycle 2, and olanzapine 5 mg tablet in chemotherapy cycle 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women with gynecological cancer receiving carboplatin-based chemotherapeutic regimen
- ECOG performance status 0-1
- Normal bone marrow, liver, and renal functions
- Can speak and write in Thai language
Key exclusion criteria (14 listed)
- Women with nausea or vomiting prior to chemotherapeutic administration
- Pregnant women
- Women with active infection
- Women with bowel obstruction
- Women with symptomatic brain metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olanzapine 10 Mg ORAL TABLET* Olanzapine 10 mg orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1) * Olanzapine 10 mg orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4 | Drug | OLN 0-5-10, OLN 10-0-5, OLN 5-10-0 |
| Olanzapine 5 Mg ORAL TABLET* Olanzapine 5 mg orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1) * Olanzapine 5 mg orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4 | Drug | OLN 0-5-10, OLN 10-0-5, OLN 5-10-0 |
| Placebo ORAL TABLET* Placebo 1 tab orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1) * Placebo 1 tab orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4 | Drug | OLN 0-5-10, OLN 10-0-5, OLN 5-10-0 |
Primary outcome
Complete response rate of chemotherapy-induced nausea and vomiting prophylaxis
Time frame: 5 days after chemotherapeutic administration
No breakthrough vomiting and no using rescue therapy
4 secondary outcomes
Episodes of vomiting
Time frame: 5 days after chemotherapeutic administration
Severity of nausea
Time frame: 5 days after chemotherapeutic administration
Use of rescue drug
Time frame: 5 days after chemotherapeutic administration
Quality of life associated with nausea and vomiting measured using Functional Living Index-Emesis (FILE)
Time frame: 5 days after chemotherapeutic administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olanzapine 10 Mg ORAL TABLET and Olanzapine 5 Mg ORAL TABLET in people with Complete Response Rate to Chemotherapy-induced Nausea and Vomiting Prophylaxis, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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 4 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 21 Jan 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 Thailand. 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 rate of chemotherapy-induced nausea and vomiting prophylaxis (time frame: 5 days after chemotherapeutic administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2022.