Chemotherapy-induced Nausea and VomitingNCT03601871

The Efficacy and Safety of Thalidomide in Preventing CINV Induced by Cisplatin-containing Chemotherapy

A study testing Thalidomide, Dexamethasone and 5-HT3 antagonists in people with Chemotherapy-induced Nausea and Vomiting, run by Yunpeng Liu at 29 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Chemotherapy-induced Nausea and Vomiting
What is being tested?: Thalidomide, Dexamethasone and 5-HT3 antagonists
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 880 participants
Where: 29 sitesChina
Study dates: 12 Jul 2018to 30 Dec 2020
Phase: Interventional
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

Who may be able to join

18y ≤Age≤70y
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Histologically confirmed solid neoplasm
No prior chemotherapy
Laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/ L, neutrophil count ≥1.5×109/L, platelet count ≥85×109/L, creatinine clearance rate (CCr) ≥60ml/min, total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), blood glucose ≤11.1 mmol/L
Life expectancy of at least 12 weeks

Show all 9Show fewer

Signed informed consent
For women with child bearing potential, a negative serum or urine pregnancy test result should be obtained before enrollment;the patients and their couples should receive contraception for at least 3 years after their last dosage of thalidomide.
Cancer patients scheduled to receive chemotherapy containing a 50 mg/m2 or higher dose of cisplatin for 4-6 cycles

Who cannot join

Diabetic patients
Pregnant or lactated women
Patient with history of severe thrombosis
Concomitant radiotherapy
Known hypersensitivity yo thalidomide, palonosetron, or dexamethasone.
Concurrent administration of any other drug which affect antiemetic effect evaluation such as proton pump inhibitor, H2 blocker, amifostine, sedative drugs

Show all 13Show fewer

Cyclophosphamide, hydroxydaunomycin, Oncovin, and prednisone (CHOP )regiment or taxanes-based regiment
Existing emesis within 24 hours before chemotherapy administration
Symptomatic brain metastasis or suspected clinical brain metastasis
Serious uncontrolled systemic illness or medical condition: congestive heart failure, unstable angina, history of documented myocardial infarction within 6 months, uncontrolled hypertension and high risk uncontrollable arrhythmias; Obvious neurological or mental abnormalities including mental disorder, epileptic dementia, which affect compliance; Uncontrolled acute infections; Uncontrolled peptic ulcer or other contraindication for corticosteroid therapy.
Inability to take or absorb oral medicine
Concurrent administration of any other investigational drug, or have been enrolled in other clinical trial with investigational drug treatment within the 30 days of start of study treatment
Unsuitable for the study or other chemotherapy determined by investigator

Trial locations and contacts

29 sites in 1 country.

Xiujuan Qu, PhD. M.D. contact

024-83282542

qu_xiujuan@hotmail.com

Lingyun Zhang, PhD. M.D. contact

024-83282312

zhangly1105@126.com

City, postcode or hospital

Sites recruiting now only

29 sites in 1 country

China29 sites, 29 recruiting

Anshan Hospital of First Hospital of China Medical University
Anshan, Liaoning
Mingran Sun, PhD.M.D.
Mingran Sun
Not yet recruiting
Anshan Tumor Hospital
Anshan, Liaoning
Xiuna Zhang, M.D.
Xiuna Zhang
Not yet recruiting
Central Hospital of Anshan City
Anshan
Chuanchun Leng
Chuanchun Leng
Not yet recruiting
Benxi Central Hospital
Benxi
Tiejun Chen
Tiejun Chen
Not yet recruiting
Chaoyang Central Hospital
Chaoyang
Xiujie Cui
Xiujie Cui
Not yet recruiting
Central hospital of Dalian
Dalian, Liaoning
Wei Huo
Wei huo
Not yet recruiting
Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
Zhaoxia Dai, M.D.
Zhaoxia Dai
Not yet recruiting
The Fifth Hospital of Dalian City
Dalian, Liaoning
Jilai Bian
Jilai Bian
Not yet recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
Jiwei Liu, PhD;M.D.
Jiwei Liu
Not yet recruiting
Zhuanghe Central Hospital
Dalian, Liaoning
Huali Tang
Huali Tang
Not yet recruiting
Zhongshan Hospital
Dalian
Xuening Ji, M.D.
Xuening Ji
Not yet recruiting
Fushun Central Hospital
Fushun, Liaoning
Li Ning
Li Ning
Recruiting
General Hospital of Mining Bureau
Fushun, Liaoning
Yuyang Zhang
Yuyang Zhang
Not yet recruiting
cancer hospital of Haerbin Medical University
Haerbin, Heilongjiang
Jin Wu, M.D.
Not yet recruiting
Jinzhou Central Hospital
Jinzhou, Liaoning
Wei Wang
Wei Wang
Not yet recruiting
The First Hospital of Liaoning Medical University
Jinzhou, Liaoning
Zhitu Zhu
Zhitu Zhu
Not yet recruiting
Chinese Medicine Hospital of Liaoyang county
Liaoyang, Liaoning
Haifeng Liu, M.D.
Haifeng Liu
Not yet recruiting
Liaoyang Central Hospital
Liaoyang, Liaoning
Jian Zhang, M.D.
Jian Zhang
Not yet recruiting
Petrochemical General Hospital of Liaoyang city
Liaoyang, Liaoning
Hao Chen
Hao Chen
Not yet recruiting
Panjin central Hospital
Panjin, Liaoning
Junwei Zhang
Junwei Zhang
Not yet recruiting
Liaohe Oilfield General Hospital
Panjin
Qiang Chen
Qiang Chen
Not yet recruiting
Chest Hospital of Shenyang City
Shengyang, Liaoning
Yinyin Li
Yinyin Li
Not yet recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Huawei Zou, M.D.
Huawei Zou
Not yet recruiting
General Hospital of Shenyang Military Region
Shenyang, Liaoning
Zhendong Zheng
Not yet recruiting
Liaoning Tumor Hospital & Institute
Shenyang, Liaoning
Yu Tang, M.D.
Yu Tang
Not yet recruiting
The First Hospital of China Medical University
Shenyang, Liaoning
Yunpeng Liu, M.D.;Ph.D.
Yunpeng Liu
Recruiting
the People'S Hospital
Shenyang, Liaoning
Lijie He, M.D.
Lijie He
Not yet recruiting
Siping City Cancer Hospital
Siping, Jilin
Zhuohui Qu
Zhuohui Qu
Not yet recruiting
Tieling city Central Hospital
Tieling, Liaoning
Huijun Zhang
Huijun Zhang
Not yet recruiting

Other trials in China

About this study

Official title: The Efficacy and Safety of Thalidomide in Preventing Multi-cycle, Cisplatin-containing CINV: a Pragmatic Randomized Open-label Clinical Trial

Read the detailed description

This is a pragmatic randomized, multi-center, open-label randomized clinical trial, aimed to evaluate efficacy and safety of thalidomide in improving prevention of chemotherapy-induced delayed nausea and vomiting (CINV) in chemotherapy-naive patients after multi-cycle cisplatin-containing highly emetogenic chemotherapy (HEC) . A total of 880 patients are planned to be enrolled into the study. Chemotherapy-naïve patients treated with multi-cycle cisplatin-containing chemotherapy will be randomized into two groups(thalidomide group and control group), and be treated with Thalidomide+5-hydroxytryptamine receptor(5-HT3) antagonist +Dexamethasone (Thalidomide group) or 5-HT3 antagonist + Dexamethasone(control group), respectively. The primary end point is no nausea rate in delayed phase of the first cycle chemotherapy, and the secondary end points include the complete response rate of vomiting in acute,delayed and overall period; no nausea rate in acute and overall phase; anorexia score, fatigue score and sedation score assessed by VAS ; safety and quality of life (QOL) during multi-cycle chemotherapy.

Conditions: Chemotherapy-induced Nausea and Vomiting
Being tested: Thalidomide, Dexamethasone, 5-HT3 antagonists
Keywords: Thalidomide, Chemotherapy-induced Nausea and Vomiting, cisplatin
Medical subject headings: Vomiting

What participants receive

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

ThalidomideDrug
Thalidomide (Thalidomide Oral Product)100 mg by mouth twice a day on days 1-5 after chemotherapy .
DexamethasoneDrug
Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4
5-HT3 antagonistsDrug
Also called Palonosetron, or 1st-generation 5-HT3 antagonists
Palonosetron 0.25 mg intravenously on day 1; or 1st-generation 5-HT3 antagonists (used as clinal routine) on day 1-3

Study groups in NCT03601871
Study group	Role	What they receive
Control group	Active comparator	Palonosetron 0.25 mg intravenously on day 1; or 1st-generation 5-HT3 antagonists (used as clinal routine) on day 1-3; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4. Receives: Drug: Dexamethasone; Drug: 5-HT3 antagonists
Thalidomide group	Experimental	Thalidomide 100 mg by mouth twice a day on days 1-5; Palonosetron 0.25 mg intravenously on day 1; or 1st-generation 5-HT3 antagonists (used as clinal routine) on day 1-3; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4. Receives: Drug: Thalidomide; Drug: Dexamethasone; Drug: 5-HT3 antagonists

What is being measured

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

No nausea （self report sclae VAS=0）rate in delayed phase (Days2-7) in the first cycle chemotherapy
The rate of no nausea on Day 2-7 in the first chemotherapy cycle (each cycle is 21 days).
The no nausea is defined as score zero with a self-report measure scale,the visual analogue (VAS) scale (0,no symptom, 10, most severely).
Measured: Day 2-7 in the first chemotherapy cycle(each cycle is 21 days)

Secondary outcomes (7)

No nausea rates （VAS=0）for delayed phases (Days2-7) during 2nd to 4th or 6th chemotherapy cycle,respectively.
The rates of no nausea on day 2-7 in 2nd-4th or 6th cycle (each cycle is 21 days).
The no nausea is defined as score zero with a self-report measure scale,the visual analogue (VAS) scale (0,no symptom, 10, most severely).
Measured: Day 2-7 in each chemotherapy cycle (each cycle is 21 days)
The complete response rates of vomiting (no emetic episode and no rescue) in acute (Day1),delayed(Day2-7), and overall phase(Day 1-7) during 1st to 4th or 6th cycle, respectively.
The rates of no emetic episode and no rescue in acute(Day1),delayed(Day2-7), and overall phase(Day 1-7) during 1st to 4th or 6th cycle, respectively.(each cycle is 21 days). An emetic episode is defined as one occurrence of vomiting or a sequence of occurrences in close succession not relieved by a rest period of at least 1 min; any number of episodes of retching in a 5-minute period; or an episode of retching of , 5 minutes combined with vomiting not relieved in a 1-minute period.
Measured: Day 1-7 in 4-6 cycles(each cycle is 21 days)
The rate of no anorexia (VAS=0) and score of anorexia (assessed by VAS) in Day1-7 during 1st-4th or 6th cycle chemotherapy
The rate of no anorexia (VAS=0) and score of anorexia assessed by VAS in multi-cycle chemotherapy. Anorexia score is evaluated with VAS (0,no symptom, 10, most severely)
Measured: Day 1-7 in each cycle(each cycle is 21 days)
The score of fatigue by VAS in day1-7 in1st to 4th or 6th chemotherapy cycle,respectively.
The score of fatigue by self-report scale VAS in day1-7 in1st to 4th or 6th chemotherapy. fatigue is evaluated with self-report scale VAS (0,no symptom, 10, most severely）
Measured: Day 1-7 in each cycle(each cycle is 21 days)
The score of sedation(by self-report VAS) in day 1-7 in each cycle
The score of sedation(by self-report VAS) in day 1-7 in each cycle, respectively.Sedation is evaluated with self-report VAS (0,no symptom, 10, most severely）
Measured: Day 1-7 in each cycle(each cycle is 21 days)
Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 in multi-cycle chemotherapy
Number of participants with Treatment-Related Adverse Events as assessed by CTCAE v4.0, in 4-6 cycles (each cycle is 21 days).
Measured: Day 1-21 in each cycle(each cycle is 21 days) during 4-6 chemotherapy cycles (each cycle is 21 days)
The quality of life scores (evaluated with Functional Living Index-Emesis (FLIE) questionnaire) of patients when receiving multi-cycle chemotherapy
The change of quality of life scores from baseline of patients (before chemotherapy) to D8 after chemotherapy in each cycle (each cycle is 21 days). The quality of life are evaluated with Functional Living Index-Emesis (FLIE) questionnaire.
Measured: Day 1-8 in each cycle(each cycle is 21 days) during 4-6 chemotherapy cycles.

Timeline

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

12 Jul 201830 Dec 2020

First posted26 Jul 2018
Study start12 Jul 2018
Primary completion30 Jun 2020 (estimated)
Study completion30 Dec 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 880 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03601871
Sponsor's protocol ID: CLOG1801
Status last verified: Jul 2018
First submitted: 30 May 2018
Last updated: 26 Jul 2018
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Xiujuan Qu, PhD. M.D.

024-83282542

qu_xiujuan@hotmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
RecruitingObservational study
HR20013 for the Prevention of Nausea and Vomiting in Patients With Cancer: A Real-World Study
Chemotherapy-Induced Nausea and Vomiting (CINV), Nausea
RecruitingPhase 1
A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults
Chemotherapy-Induced Nausea and Vomiting (CINV), Radiotherapy-induced Nausea and Vomiting (RINV)
Active, not recruiting
Vomiting Prevention in Children With Cancer
Chemotherapy Induced Nausea and Vomiting, Quality of Life (QOL)
RecruitingPhase 2
Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC)
Nausea and Vomiting Chemotherapy-Induced, Nausea Post Chemotherapy

All Chemotherapy-induced Nausea and Vomiting trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy and Safety of Thalidomide in Preventing Multi-cycle, Cisplatin-containing CINV: a Pragmatic Randomized Open-label Clinical Trial
ClinicalTrials.gov ID: NCT03601871
Acronym / sponsor ID: CLOG1801
Conditions: Chemotherapy-induced Nausea and Vomiting
Keywords: Thalidomide, Chemotherapy-induced Nausea and Vomiting, cisplatin
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 880 participants (estimated)
Lead sponsor: Yunpeng LiuUniversity, hospital or other
Study start: 12 Jul 2018 (actual)
Primary completion: 30 Jun 2020 (estimated)
Study completion: 30 Dec 2020 (estimated)
First posted: 26 Jul 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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control group	Active comparator	Drug: Dexamethasone, Drug: 5-HT3 antagonistsPalonosetron 0.25 mg intravenously on day 1; or 1st-generation 5-HT3 antagonists (used as clinal routine) on day 1-3; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4.
Thalidomide group	Experimental	Drug: Thalidomide, Drug: Dexamethasone, Drug: 5-HT3 antagonistsThalidomide 100 mg by mouth twice a day on days 1-5; Palonosetron 0.25 mg intravenously on day 1; or 1st-generation 5-HT3 antagonists (used as clinal routine) on day 1-3; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

18y ≤Age≤70y
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Histologically confirmed solid neoplasm
No prior chemotherapy
Laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/ L, neutrophil count ≥1.5×109/L, platelet count ≥85×109/L, creatinine clearance rate (CCr) ≥60ml/min, total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), blood glucose ≤11.1 mmol/L

Key exclusion criteria (13 listed)

Diabetic patients
Pregnant or lactated women
Patient with history of severe thrombosis
Concomitant radiotherapy
Known hypersensitivity yo thalidomide, palonosetron, or dexamethasone.

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
ThalidomideThalidomide (Thalidomide Oral Product)100 mg by mouth twice a day on days 1-5 after chemotherapy .	Drug	Thalidomide group
DexamethasoneDexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4	Drug	Control group, Thalidomide group
5-HT3 antagonistsAlso: Palonosetron, or 1st-generation 5-HT3 antagonistsPalonosetron 0.25 mg intravenously on day 1; or 1st-generation 5-HT3 antagonists (used as clinal routine) on day 1-3	Drug	Control group, Thalidomide group

Primary outcome

No nausea （self report sclae VAS=0）rate in delayed phase (Days2-7) in the first cycle chemotherapy
Time frame: Day 2-7 in the first chemotherapy cycle(each cycle is 21 days)
The rate of no nausea on Day 2-7 in the first chemotherapy cycle (each cycle is 21 days). The no nausea is defined as score zero with a self-report measure scale,the visual analogue (VAS) scale (0,no symptom, 10, most severely).

7 secondary outcomes

No nausea rates （VAS=0）for delayed phases (Days2-7) during 2nd to 4th or 6th chemotherapy cycle,respectively.
Time frame: Day 2-7 in each chemotherapy cycle (each cycle is 21 days)
The complete response rates of vomiting (no emetic episode and no rescue) in acute (Day1),delayed(Day2-7), and overall phase(Day 1-7) during 1st to 4th or 6th cycle, respectively.
Time frame: Day 1-7 in 4-6 cycles(each cycle is 21 days)
The rate of no anorexia (VAS=0) and score of anorexia (assessed by VAS) in Day1-7 during 1st-4th or 6th cycle chemotherapy
Time frame: Day 1-7 in each cycle(each cycle is 21 days)
The score of fatigue by VAS in day1-7 in1st to 4th or 6th chemotherapy cycle,respectively.
Time frame: Day 1-7 in each cycle(each cycle is 21 days)
The score of sedation(by self-report VAS) in day 1-7 in each cycle
Time frame: Day 1-7 in each cycle(each cycle is 21 days)
Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 in multi-cycle chemotherapy
Time frame: Day 1-21 in each cycle(each cycle is 21 days) during 4-6 chemotherapy cycles (each cycle is 21 days)
The quality of life scores (evaluated with Functional Living Index-Emesis (FLIE) questionnaire) of patients when receiving multi-cycle chemotherapy
Time frame: Day 1-8 in each cycle(each cycle is 21 days) during 4-6 chemotherapy cycles.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
Individual participant dataSharing planned: No

Related trials for Chemotherapy-induced Nausea and Vomiting

RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
RecruitingObservational study
HR20013 for the Prevention of Nausea and Vomiting in Patients With Cancer: A Real-World Study
Chemotherapy-Induced Nausea and Vomiting (CINV), Nausea
RecruitingPhase 1
A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults
Chemotherapy-Induced Nausea and Vomiting (CINV), Radiotherapy-induced Nausea and Vomiting (RINV)
Active, not recruiting
Vomiting Prevention in Children With Cancer
Chemotherapy Induced Nausea and Vomiting, Quality of Life (QOL)
RecruitingPhase 2
Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC)
Nausea and Vomiting Chemotherapy-Induced, Nausea Post Chemotherapy

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.

Xiujuan Qu, PhD. M.D. contact

024-83282542

qu_xiujuan@hotmail.com

Lingyun Zhang, PhD. M.D. contact

024-83282312

zhangly1105@126.com

Yunpeng Liu, PhD. M.D. principal investigator

China Medical University, China

29 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Thalidomide, Dexamethasone and 5-HT3 antagonists in people with Chemotherapy-induced Nausea and Vomiting, run by Yunpeng Liu at 29 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 9 inclusion and 13 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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 Xiujuan Qu, PhD. M.D. (024-83282542, qu_xiujuan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

No nausea （self report sclae VAS=0）rate in delayed phase (Days2-7) in the first cycle chemotherapy (time frame: Day 2-7 in the first chemotherapy cycle(each cycle is 21 days)). 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 NCT03601871.

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 26 Jul 2018; AzTrials last refreshed its copy on 7 Nov 2026.