Chemotherapy-induced Nausea and VomitingPhase 4NCT03571126
Olanzapine for the Prevention and Treatment of Nausea and Vomiting Induced by Chemotherapy of Lung Cancer
A Phase 4 study testing Olanzapine in people with Chemotherapy-induced Nausea and Vomiting and Lung Cancer, run by Zunyi Medical College at 2 sites in China.
Trial summary
Chemotherapy induced nausea and vomiting (CINV) is a common adverse effect in treatment of cancer, which influences the quality of life and adherence to treatment of patients and leads to dehydration, malnutrition and even death. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting, Lung Cancer
- What is being tested?
- Olanzapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 2 sitesChina
- Study dates
- 9 May 2019to 1 Aug 2023
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) Performance Status≤2 or Karnofsky performance statu (KPS) scores≥60.
- Patients with cytologically or histologically confirmed lung cancer.
- Patients who are willing to receive chemotherapy and can tolerate at least 2 cycles chemotherapy.
- Chemotherapy regimens accord with standard regimens recommended by clinical practice guidelines (National Comprehensive Cancer Network guidelines and Chinese Society of Clinical Oncology guidelines of lung cancer).
- There is at least one kind of high emetic risk chemotherapy agent, mainly including regimens contain cisplatin or carboplatin (AUC≥4).
- Adequate organ function including the following: Adequate bone marrow reserve: white blood cell (WBC) count superior or equal to 2.0×10^9/L , absolute neutrophil count (ANC) superior or equal to 1.5×10^9/L, platelets superior or equal to 80×10^9/L, and hemoglobin superior or equal to 90g/L; Hepatic: bilirubin <1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5×ULN (or <5×ULN with liver metastases); Renal: Serum creatinine≤1×ULN, calculated creatinine clearance (CrCl) superior or equal to 50 milliliter/min based on the standard Cockcroft and Gault formula.
- At least 3 weeks after the end of the last chemotherapy.
- Women of reproductive years are willing to contracept in appropriate methods in the period of trial and in the 8 weeks after the last administration. Doing pregnancy test before the beginning of this trial when necessary, and results of which need to be negative.
Who cannot join
- Women who are pregnant or breastfeeding
- Need to undergo radiotherapy during this trial.
- Patients with alimentary tract obstruction.
- Patients with severe heart disease, renal and liver disease and metabolic abnormalities.
- Patients with epilepsy or who are using antipsychotics.
- Patients who have been administrated with antiemetic in 24 hours or who have suffered vomiting before chemotherapy.
Show all 10Show fewer
- Patients with brain metastases.
- Patients with contraindications of chemotherapy.
- Patients who are attending another clinical trial or will attend in 2 weeks.
- Patients who are considered unsuitable to be included by treating physicians.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan
Xian-Bang Tan, MD
Xian-Bang Tan, MD
- Recruiting
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000
Jian-Guo Zhou, 18311543939, jianguo.zhou@yahoo.com
hu ma, phd
About this study
Official title: Olanzapine as First Line Treatment for Prevention of Nausea and Vomiting Induced by Chemotherapy of Lung Cancer: a Multicenter, Double-blind and Randomized Trial
Chemotherapy induced nausea and vomiting (CINV) is a common adverse effect in treatment of cancer, which influences the quality of life and adherence to treatment of patients and leads to dehydration, malnutrition and even death. Prevention and relieving the CINV is an important step to ensure the conduction of chemotherapy. Mechanism of CINV remains to be obscure, while most studies showed that it is mainly related to the following respects: ⑴ Chemotherapeutic agents stimulate gastrointestinal tract, which induces the release of neurotransmitters by chromaffin cells. Neurotransmitters bind to corresponding receptors, and then results in vomiting by stimulating the vomiting center; ⑵ Chemotherapeutic agents and the metabolites of them activate chemoreceptors directly, which causes vomiting. ⑶ Feeling and mental factors irritate cerebral cortex pathway directly. There are studies suggested that 5- hydroxytryptamine (5-HT) was related to acute nausea and vomiting induced by chemotherapy, which means 5-HT receptor antagonist would be a effective medicine for acute CINV. In addition, there are researches proclaimed that neurokinin-1 (NK-1) receptor antagonist, aprepitant, is a potent agent to relieve CINV. Thus, correlative guidelines recommend regimens with 5-HT receptor antagonist, NK-1 receptor antagonist and glucocorticoid as the standard treatment for strongly emetic chemotherapy regimens. But the prevention of moderately emetic chemotherapy regimens remains to be a problem in clinical practice. Besides, there is no study to demonstrate differences of mechanisms between acute CINV and delayed CINV. Olanzapine inhibits kinds of neurotransmitters which cause CINV, it is why this medicine is effective in both acute and delayed CINV. It can also alleviate anxiety, improve sleep quality and relieve pain in patients with cancer. The most common adverse effects of olanzapine are lethargy, body mass increase, fatigue, dry mouth, constipation, hyperlipidemia and hyperglycemia. Among them, the most common one is lethargy, which can oppose insomnia and excitation caused by dexamethasone. In a word, olanzapine is an agent with mild adverse effects, it is worth to be generalized. But there are still problems to be resolved in the application of olanzapine in CINV: ⑴ Aprepitant is expensive and not covered in medical care in China, which limits the application in patients. ⑵There is no large clinical trial to confirm the efficacy and safety of olanzapine in Chinese populations. To explore these issues better, investigators intend to compare the regimen with olanzapine, dexamethasone and 5-HT receptor antagonists with the regimen with placebo, dexamethasone and 5-HT receptor antagonists about the efficacy and adverse events in treatment of CINV. Investigators aim to provide an available therapeutic options for CINV, improve the quality of life and prolong the survival of patients with lung cancer.
- Being tested
- Olanzapine, Placebos
- Medical subject headings
- Vomiting, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Dexamethasone (10mg/d) (Days1-3) Tropisetron (4mg or 4.48mg or 5mg /d) (Days1-3) Olanzapine (10mg/d) (Days1-4)
PlacebosDrug
Dexamethasone (10mg/d) (Days1-3) Tropisetron (4mg or 4.48mg or 5mg /d) (Days1-3) Placebos (Days1-4)
| Study group | Role | What they receive |
|---|---|---|
| Placebos group | Placebo comparator | Patients will be administered with dexamethasone plus tropisetron from D1 to D3.
Patients will also be administrated with placebos from D1-D4 Receives: Drug: Placebos |
| Experimental group | Experimental | Patients will receive a regimen with dexamethasone plus tropisetron from D1-D3. Patients will also be administrated with olanzapine from D1-D4. Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of no delayed nausea and vomiting
Number of participants with nausea and vomiting occuring within 24 hours after chemotherapy in all participants.
Measured: 1 week
Secondary outcomes (6)
Complete response of acute nausea and vomiting
Number of participants with no nausea and vomiting occuring within 24 hours after chemotherapy as assessed by CTCAE v4.0.
Measured: 1 week
Complete response of delayed nausea and vomiting
Number of participants with no nausea and vomiting occuring in 24 hours to 120 hours after chemotherapy as assessed by CTCAE v4.0.
Measured: 1 week
Disease control rate
Number of participants who reach complete response or partial response.
Measured: 1 week
Quality of life of participants by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 scale
Quality of life of participants is measured with The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13(QLQ-LC13) scale which is filled by participants themselves. The questionnaire is consist of several symptoms measured by scores range from 1 to 7, the higher the symptoms are scored, the worse the quality of life is.
Measured: 1 week
Quality of life of participants by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 30 scale
Quality of life of participants is measured with EORTC QLQ-LC30 scale which is filled by participants themselves. The questionnaire is consist of several symptoms measured by scores range from 1 to 7, the higher the symptoms are scored, the worse the quality of life is.
Measured: 1 week
Quality of life of participants by Functional Assessment of Cancer Therapy-Lung cancer scale
Quality of life of participants is measured with Functional Assessment of Cancer Therapy-Lung cancer (FACT-L) scale which is filled by participants themselves. The FACT-L, version 4, is a combination of the 27-item FACT-General (FACT-G) and the 9-item Lung Cancer Subscale (LCS) which measures multidimensional quality of life. The FACT-L score ranges from 0 to 136. The higher the score obtained by each patient in question, the greater the final score of the subscale and the better the quality of life.
Measured: 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start9 May 2019
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zunyi Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Zunyi First People's Hospital, Affiliated Hospital of North Sichuan Medical College, Sichuan Cancer Hospital and Research Institute, Guizhou Provincial People's Hospital, Affiliated Hospital of Southwest Medical University
- Responsible party
- Principal investigator, Jian-Guo Zhou,MD, Zunyi Medical College
- Investigators
- Hu Ma, Doctor, Principal investigator, Zunyi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571126
- Sponsor's protocol ID
- 20180520
- Status last verified
- Jul 2021
- First submitted
- 7 Jun 2018
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data will be available to other researchers in this study and physicians treating study participants.Jiangsu Famous Medicine Co.,Ltd. provide EDC.
Publications
Hesketh PJ, Kris MG, Basch E, Bohlke K, Barbour SY, Clark-Snow RA, Danso MA, Dennis K, Dupuis LL, Dusetzina SB, Eng C, Feyer PC, Jordan K, Noonan K, Sparacio D, Somerfield MR, Lyman GH. Antiemetics: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2017 Oct 1;35(28):3240-3261. doi: 10.1200/JCO.2017.74.4789. Epub 2017 Jul 31.
PubMed 28759346Adel N. Overview of chemotherapy-induced nausea and vomiting and evidence-based therapies. Am J Manag Care. 2017 Sep;23(14 Suppl):S259-S265.
PubMed 28978206Navari RM. 5-HT3 receptors as important mediators of nausea and vomiting due to chemotherapy. Biochim Biophys Acta. 2015 Oct;1848(10 Pt B):2738-46. doi: 10.1016/j.bbamem.2015.03.020. Epub 2015 Mar 30.
PubMed 25838122Navari RM, Gray SE, Kerr AC. Olanzapine versus aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a randomized phase III trial. J Support Oncol. 2011 Sep-Oct;9(5):188-95. doi: 10.1016/j.suponc.2011.05.002. Epub 2011 Sep 24.
PubMed 22024310Geling O, Eichler HG. Should 5-hydroxytryptamine-3 receptor antagonists be administered beyond 24 hours after chemotherapy to prevent delayed emesis? Systematic re-evaluation of clinical evidence and drug cost implications. J Clin Oncol. 2005 Feb 20;23(6):1289-94. doi: 10.1200/JCO.2005.04.022.
PubMed 15718327Walsh D, Davis M, Ripamonti C, Bruera E, Davies A, Molassiotis A. 2016 Updated MASCC/ESMO consensus recommendations: Management of nausea and vomiting in advanced cancer. Support Care Cancer. 2017 Jan;25(1):333-340. doi: 10.1007/s00520-016-3371-3. Epub 2016 Aug 17.
PubMed 27534961Passik SD, Kirsh KL, Theobald DE, Dickerson P, Trowbridge R, Gray D, Beaver M, Comparet J, Brown J. A retrospective chart review of the use of olanzapine for the prevention of delayed emesis in cancer patients. J Pain Symptom Manage. 2003 May;25(5):485-8. doi: 10.1016/s0885-3924(03)00078-2.
PubMed 12727048Zhang Z, Zhang Y, Chen G, Hong S, Yang Y, Fang W, Luo F, Chen X, Ma Y, Zhao Y, Zhan J, Xue C, Hou X, Zhou T, Ma S, Gao F, Huang Y, Chen L, Zhou N, Zhao H, Zhang L. Olanzapine-Based Triple Regimens Versus Neurokinin-1 Receptor Antagonist-Based Triple Regimens in Preventing Chemotherapy-Induced Nausea and Vomiting Associated with Highly Emetogenic Chemotherapy: A Network Meta-Analysis. Oncologist. 2018 May;23(5):603-616. doi: 10.1634/theoncologist.2017-0378. Epub 2018 Jan 12.
PubMed 29330211
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olanzapine as First Line Treatment for Prevention of Nausea and Vomiting Induced by Chemotherapy of Lung Cancer: a Multicenter, Double-blind and Randomized Trial
- ClinicalTrials.gov ID
- NCT03571126
- Acronym / sponsor ID
- 20180520
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Zunyi Medical CollegeUniversity, hospital or other
- Collaborators
- Zunyi First People's Hospital, Affiliated Hospital of North Sichuan Medical College, Sichuan Cancer Hospital and Research Institute, Guizhou Provincial People's Hospital, Affiliated Hospital of Southwest Medical University
- Study start
- 9 May 2019 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 27 Jun 2018 (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.
Chemotherapy induced nausea and vomiting (CINV) is a common adverse effect in treatment of cancer, which influences the quality of life and adherence to treatment of patients and leads to dehydration, malnutrition and even death. Prevention and relieving the CINV is an important step to ensure the conduction of chemotherapy. Mechanism of CINV remains to be obscure, while most studies showed that it is mainly related to the following respects: ⑴ Chemotherapeutic agents stimulate gastrointestinal tract, which induces the release of neurotransmitters by chromaffin cells. Neurotransmitters bind to corresponding receptors, and then results in vomiting by stimulating the vomiting center; ⑵ Chemotherapeutic agents and the metabolites of them activate chemoreceptors directly, which causes vomiting. ⑶ Feeling and mental factors irritate cerebral cortex pathway directly. There are studies suggested that 5- hydroxytryptamine (5-HT) was related to acute nausea and vomiting induced by chemotherapy, which means 5-HT receptor antagonist would be a effective medicine for acute CINV. In addition, there are researches proclaimed that neurokinin-1 (NK-1) receptor antagonist, aprepitant, is a potent agent to relieve CINV. Thus, correlative guidelines recommend regimens with 5-HT receptor antagonist, NK-1 receptor antagonist and glucocorticoid as the standard treatment for strongly emetic chemotherapy regimens. But the prevention of moderately emetic chemotherapy regimens remains to be a problem in clinical practice. Besides, there is no study to demonstrate differences of mechanisms between acute CINV and delayed CINV. Olanzapine inhibits kinds of neurotransmitters which cause CINV, it is why this medicine is effective in both acute and delayed CINV. It can also alleviate anxiety, improve sleep quality and relieve pain in patients with cancer. The most common adverse effects of olanzapine are lethargy, body mass increase, fatigue, dry mouth, constipation, hyperlipidemia and hyperglycemia. Among them, the most common one is lethargy, which can oppose insomnia and excitation caused by dexamethasone. In a word, olanzapine is an agent with mild adverse effects, it is worth to be generalized. But there are still problems to be resolved in the application of olanzapine in CINV: ⑴ Aprepitant is expensive and not covered in medical care in China, which limits the application in patients. ⑵There is no large clinical trial to confirm the efficacy and safety of olanzapine in Chinese populations. To explore these issues better, investigators intend to compare the regimen with olanzapine, dexamethasone and 5-HT receptor antagonists with the regimen with placebo, dexamethasone and 5-HT receptor antagonists about the efficacy and adverse events in treatment of CINV. Investigators aim to provide an available therapeutic options for CINV, improve the quality of life and prolong the survival of patients with lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebos group | Placebo comparator | Drug: PlacebosPatients will be administered with dexamethasone plus tropisetron from D1 to D3. Patients will also be administrated with placebos from D1-D4 |
| Experimental group | Experimental | Drug: OlanzapinePatients will receive a regimen with dexamethasone plus tropisetron from D1-D3. Patients will also be administrated with olanzapine from D1-D4. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Eastern Cooperative Oncology Group (ECOG) Performance Status≤2 or Karnofsky performance statu (KPS) scores≥60.
- Patients with cytologically or histologically confirmed lung cancer.
- Patients who are willing to receive chemotherapy and can tolerate at least 2 cycles chemotherapy.
- Chemotherapy regimens accord with standard regimens recommended by clinical practice guidelines (National Comprehensive Cancer Network guidelines and Chinese Society of Clinical Oncology guidelines of lung cancer).
- There is at least one kind of high emetic risk chemotherapy agent, mainly including regimens contain cisplatin or carboplatin (AUC≥4).
Key exclusion criteria (10 listed)
- Women who are pregnant or breastfeeding
- Need to undergo radiotherapy during this trial.
- Patients with alimentary tract obstruction.
- Patients with severe heart disease, renal and liver disease and metabolic abnormalities.
- Patients with epilepsy or who are using antipsychotics.
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 |
|---|---|---|
| OlanzapineDexamethasone (10mg/d) (Days1-3) Tropisetron (4mg or 4.48mg or 5mg /d) (Days1-3) Olanzapine (10mg/d) (Days1-4) | Drug | Experimental group |
| PlacebosDexamethasone (10mg/d) (Days1-3) Tropisetron (4mg or 4.48mg or 5mg /d) (Days1-3) Placebos (Days1-4) | Drug | Placebos group |
Primary outcome
Incidence rate of no delayed nausea and vomiting
Time frame: 1 week
Number of participants with nausea and vomiting occuring within 24 hours after chemotherapy in all participants.
6 secondary outcomes
Complete response of acute nausea and vomiting
Time frame: 1 week
Complete response of delayed nausea and vomiting
Time frame: 1 week
Disease control rate
Time frame: 1 week
Quality of life of participants by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 scale
Time frame: 1 week
Quality of life of participants by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 30 scale
Time frame: 1 week
Quality of life of participants by Functional Assessment of Cancer Therapy-Lung cancer scale
Time frame: 1 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Background: PubMed 28759346Hesketh PJ, Kris MG, Basch E, Bohlke K, Barbour SY, Clark-Snow RA, Danso MA, Dennis K, Dupuis LL, Dusetzina SB, Eng C, Feyer PC, Jordan K, Noonan K, Sparacio D, Somerfield MR, Lyman GH. Antiemetics: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2017 Oct 1;35(28):3240-3261. doi: 10.1200/JCO.2017.74.4789. Epub 2017 Jul 31.
- Background: PubMed 28978206Adel N. Overview of chemotherapy-induced nausea and vomiting and evidence-based therapies. Am J Manag Care. 2017 Sep;23(14 Suppl):S259-S265.
- Background: PubMed 25838122Navari RM. 5-HT3 receptors as important mediators of nausea and vomiting due to chemotherapy. Biochim Biophys Acta. 2015 Oct;1848(10 Pt B):2738-46. doi: 10.1016/j.bbamem.2015.03.020. Epub 2015 Mar 30.
- Background: PubMed 22024310Navari RM, Gray SE, Kerr AC. Olanzapine versus aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a randomized phase III trial. J Support Oncol. 2011 Sep-Oct;9(5):188-95. doi: 10.1016/j.suponc.2011.05.002. Epub 2011 Sep 24.
- Background: PubMed 15718327Geling O, Eichler HG. Should 5-hydroxytryptamine-3 receptor antagonists be administered beyond 24 hours after chemotherapy to prevent delayed emesis? Systematic re-evaluation of clinical evidence and drug cost implications. J Clin Oncol. 2005 Feb 20;23(6):1289-94. doi: 10.1200/JCO.2005.04.022.
- Background: PubMed 27534961Walsh D, Davis M, Ripamonti C, Bruera E, Davies A, Molassiotis A. 2016 Updated MASCC/ESMO consensus recommendations: Management of nausea and vomiting in advanced cancer. Support Care Cancer. 2017 Jan;25(1):333-340. doi: 10.1007/s00520-016-3371-3. Epub 2016 Aug 17.
- Background: PubMed 12727048Passik SD, Kirsh KL, Theobald DE, Dickerson P, Trowbridge R, Gray D, Beaver M, Comparet J, Brown J. A retrospective chart review of the use of olanzapine for the prevention of delayed emesis in cancer patients. J Pain Symptom Manage. 2003 May;25(5):485-8. doi: 10.1016/s0885-3924(03)00078-2.
- Background: PubMed 29330211Zhang Z, Zhang Y, Chen G, Hong S, Yang Y, Fang W, Luo F, Chen X, Ma Y, Zhao Y, Zhan J, Xue C, Hou X, Zhou T, Ma S, Gao F, Huang Y, Chen L, Zhou N, Zhao H, Zhang L. Olanzapine-Based Triple Regimens Versus Neurokinin-1 Receptor Antagonist-Based Triple Regimens in Preventing Chemotherapy-Induced Nausea and Vomiting Associated with Highly Emetogenic Chemotherapy: A Network Meta-Analysis. Oncologist. 2018 May;23(5):603-616. doi: 10.1634/theoncologist.2017-0378. Epub 2018 Jan 12.
- Individual participant dataSharing planned: Yes. The individual participant data will be available to other researchers in this study and physicians treating study participants.Jiangsu Famous Medicine Co.,Ltd. provide EDC.
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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.
Hu Ma, Doctor principal investigator
Zunyi Medical College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Olanzapine in people with Chemotherapy-induced Nausea and Vomiting and Lung Cancer, run by Zunyi Medical College at 2 sites 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 8 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 13 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 2 sites 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JianGuo Zhou, Master (+86 18311543939, jianguo.zhou@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of no delayed nausea and vomiting (time frame: 1 week). 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 NCT03571126, which also lists 8 linked publications.
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 13 Jul 2021.