- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03601871
The Efficacy and Safety of Thalidomide in Preventing CINV Induced by Cisplatin-containing Chemotherapy
The Efficacy and Safety of Thalidomide in Preventing Multi-cycle, Cisplatin-containing CINV: a Pragmatic Randomized Open-label Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xiujuan Qu, PhD. M.D.
- Phone Number: 024-83282542
- Email: qu_xiujuan@hotmail.com
Study Contact Backup
- Name: Lingyun Zhang, PhD. M.D.
- Phone Number: 024-83282312
- Email: zhangly1105@126.com
Study Locations
-
-
-
Anshan, China
- Not yet recruiting
- Central Hospital of Anshan City
-
Contact:
- Chuanchun Leng
-
Sub-Investigator:
- Chuanchun Leng
-
Benxi, China
- Not yet recruiting
- Benxi Central Hospital
-
Contact:
- Tiejun Chen
-
Sub-Investigator:
- Tiejun Chen
-
Chaoyang, China
- Not yet recruiting
- Chaoyang Central Hospital
-
Contact:
- Xiujie Cui
-
Sub-Investigator:
- Xiujie Cui
-
Dalian, China
- Not yet recruiting
- Zhongshan Hospital
-
Contact:
- Xuening Ji, M.D.
-
Sub-Investigator:
- Xuening Ji
-
Sub-Investigator:
- Gang Wang
-
Sub-Investigator:
- Tong Zhao
-
Panjin, China
- Not yet recruiting
- Liaohe Oilfield General Hospital
-
Contact:
- Qiang Chen
-
Sub-Investigator:
- Qiang Chen
-
-
Heilongjiang
-
Haerbin, Heilongjiang, China
- Not yet recruiting
- cancer hospital of Haerbin Medical University
-
Contact:
- Jin Wu, M.D.
-
-
Jilin
-
Siping, Jilin, China
- Not yet recruiting
- Siping City Cancer Hospital
-
Contact:
- Zhuohui Qu
-
Sub-Investigator:
- Zhuohui Qu
-
-
Liaoning
-
Anshan, Liaoning, China
- Not yet recruiting
- Anshan Hospital of First Hospital of China Medical University
-
Contact:
- Mingran Sun, PhD.M.D.
-
Sub-Investigator:
- Mingran Sun
-
Anshan, Liaoning, China
- Not yet recruiting
- Anshan Tumor Hospital
-
Contact:
- Xiuna Zhang, M.D.
-
Sub-Investigator:
- Xiuna Zhang
-
Sub-Investigator:
- Jinfang Lv
-
Sub-Investigator:
- Fugang When
-
Sub-Investigator:
- Li Man
-
Dalian, Liaoning, China
- Not yet recruiting
- Central hospital of Dalian
-
Contact:
- Wei Huo
-
Sub-Investigator:
- Wei huo
-
Sub-Investigator:
- Min Zhong
-
Sub-Investigator:
- Liangwei Yin
-
Dalian, Liaoning, China
- Not yet recruiting
- Second Affiliated Hospital of Dalian Medical University
-
Contact:
- Zhaoxia Dai, M.D.
-
Sub-Investigator:
- Zhaoxia Dai
-
Sub-Investigator:
- Jun Chen
-
Dalian, Liaoning, China
- Not yet recruiting
- The Fifth Hospital of Dalian City
-
Contact:
- Jilai Bian
-
Sub-Investigator:
- Jilai Bian
-
Dalian, Liaoning, China
- Not yet recruiting
- The First Affiliated Hospital of Dalian Medical University
-
Contact:
- Jiwei Liu, PhD;M.D.
-
Sub-Investigator:
- Jiwei Liu
-
Dalian, Liaoning, China
- Not yet recruiting
- Zhuanghe central hospital
-
Contact:
- Huali Tang
-
Sub-Investigator:
- Huali Tang
-
Fushun, Liaoning, China
- Recruiting
- Fushun central hospital
-
Contact:
- Li Ning
-
Sub-Investigator:
- Li Ning
-
Fushun, Liaoning, China
- Not yet recruiting
- General Hospital of Mining Bureau
-
Contact:
- Yuyang Zhang
-
Sub-Investigator:
- Yuyang Zhang
-
Jinzhou, Liaoning, China
- Not yet recruiting
- Jinzhou Central Hospital
-
Jinzhou, Liaoning, China
- Not yet recruiting
- The First Hospital of Liaoning Medical University
-
Contact:
- Zhitu Zhu
-
Sub-Investigator:
- Zhitu Zhu
-
Liaoyang, Liaoning, China
- Not yet recruiting
- Chinese Medicine Hospital of Liaoyang county
-
Contact:
- Haifeng Liu, M.D.
-
Sub-Investigator:
- Haifeng Liu
-
Liaoyang, Liaoning, China
- Not yet recruiting
- Liaoyang Central Hospital
-
Contact:
- Jian Zhang, M.D.
-
Liaoyang, Liaoning, China
- Not yet recruiting
- Petrochemical General Hospital of Liaoyang city
-
Contact:
- Hao Chen
-
Panjin, Liaoning, China
- Not yet recruiting
- Panjin Central Hospital
-
Contact:
- Junwei Zhang
-
Sub-Investigator:
- Junwei Zhang
-
Sub-Investigator:
- Zhichang Sun
-
Sub-Investigator:
- Yu Jiang
-
Sub-Investigator:
- Qinghua Gao
-
Shengyang, Liaoning, China
- Not yet recruiting
- Chest Hospital of Shenyang City
-
Contact:
- Yinyin Li
-
Sub-Investigator:
- Yinyin Li
-
Shenyang, Liaoning, China, 110004
- Not yet recruiting
- Shengjing Hospital of China Medical University
-
Contact:
- Huawei Zou, M.D.
-
Sub-Investigator:
- Huawei Zou
-
Sub-Investigator:
- Rong Wu
-
Shenyang, Liaoning, China
- Not yet recruiting
- General Hospital of Shenyang Military Region
-
Sub-Investigator:
- Zhendong Zheng
-
Shenyang, Liaoning, China
- Not yet recruiting
- Liaoning Tumor Hospital & Institute
-
Contact:
- Yu Tang, M.D.
-
Sub-Investigator:
- Yu Tang
-
Shenyang, Liaoning, China
- Recruiting
- The First Hospital of China Medical University
-
Contact:
- Yunpeng Liu, M.D.;Ph.D.
-
Principal Investigator:
- Yunpeng Liu
-
Sub-Investigator:
- Xiujuan Qu
-
Sub-Investigator:
- Lingyun Zhang
-
Shenyang, Liaoning, China
- Not yet recruiting
- the People'S Hospital
-
Contact:
- Lijie He, M.D.
-
Sub-Investigator:
- Lijie He
-
Tieling, Liaoning, China
- Not yet recruiting
- Tieling city Central Hospital
-
Contact:
- Huijun Zhang
-
Sub-Investigator:
- Huijun Zhang
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control group
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.
|
Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4
Palonosetron 0.25 mg intravenously on day 1; or 1st-generation 5-HT3 antagonists (used as clinal routine) on day 1-3
Other Names:
|
Experimental: Thalidomide group
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.
|
Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4
Palonosetron 0.25 mg intravenously on day 1; or 1st-generation 5-HT3 antagonists (used as clinal routine) on day 1-3
Other Names:
Thalidomide (Thalidomide Oral Product)100 mg by mouth twice a day on days 1-5 after chemotherapy .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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). |
Day 2-7 in the first chemotherapy cycle(each cycle is 21 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 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). |
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 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.
|
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 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)
|
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 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)
|
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)
|
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)
|
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)
|
Number of participants with Treatment-Related Adverse Events as assessed by CTCAE v4.0, in 4-6 cycles (each cycle is 21 days).
|
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.
|
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.
|
Day 1-8 in each cycle(each cycle is 21 days) during 4-6 chemotherapy cycles.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yunpeng Liu, PhD. M.D., China Medical University, China
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Serotonin Agents
- Serotonin Antagonists
- Leprostatic Agents
- Dexamethasone
- Thalidomide
- Palonosetron
- Serotonin 5-HT3 Receptor Antagonists
Other Study ID Numbers
- CLOG1801
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chemotherapy-induced Nausea and Vomiting
-
GlaxoSmithKlineCompletedChemotherapy-Induced Nausea and Vomiting | Nausea and Vomiting, Chemotherapy-InducedTaiwan, United States, Germany, Russian Federation, Spain, Ireland, Thailand, Hong Kong, Mexico, Philippines, Austria, Chile, Greece, Poland, Canada, Czech Republic, United Kingdom, Hungary, Pakistan, Slovakia, Singapore, Portugal, ... and more
-
Blokhin's Russian Cancer Research CenterRUSSCO/RakFondUnknownChemotherapy-induced Nausea and Vomiting | Nausea | Vomiting | Emesis | Nausea Post ChemotherapyRussian Federation
-
Otolith LabsDrexel University College of MedicineWithdrawnChemotherapy-induced Nausea and Vomiting | Nausea Post ChemotherapyUnited States
-
Indonesia UniversityMashhad University of Medical SciencesRecruitingChemotherapy-induced Nausea and Vomiting | Chemotherapy Effect | Pediatric CancerIndonesia
-
Joseph MaTerminatedChemotherapy Induced Nausea Vomiting
-
Fudan UniversityNot yet recruitingChemotherapy-induced Nausea and Vomiting | Highly Emetogenic Chemotherapy
-
Simon Williamson ClinicHelsinn Healthcare SARecruitingChemotherapy Induced Nausea and VomitingUnited States
-
University of Illinois at ChicagoRecruitingChemotherapy-induced Nausea and VomitingUnited States
-
Albert Einstein College of MedicineJacobi Medical CenterTerminatedChemotherapy-induced Nausea and VomitingUnited States
-
Purdue Pharma, CanadaCompletedChemotherapy-Induced Nausea and VomitingCanada
Clinical Trials on Dexamethasone
-
Ottawa Hospital Research InstituteCompletedPain Syndrome | Early-stage Breast CancerCanada
-
Centre hospitalier de l'Université de Montréal...CompletedPrevention of Hypersensitivity Reactions to PaclitaxelCanada
-
Vanderbilt University Medical CenterTerminatedAsthma | CroupUnited States
-
Dr. Stephen ChoiThe Physicians' Services Incorporated FoundationCompletedShoulder Surgery | Nerve BlockCanada
-
Shanghai Jiao Tong University Affiliated Sixth...CompletedAnalgesia | Time | Brachial Plexus Block | Shoulder Surgery | Dexamethasone | Intravenous Drug UsageChina
-
Universidade Federal de PernambucoCompletedDiabetic Macular EdemaBrazil
-
Universitätsklinikum Hamburg-EppendorfGemeinsamer Bundesausschuss (G-BA); Staburo GmbHRecruiting
-
Poznan University of Medical SciencesRecruitingWrist Injuries | Hand Injuries | Hand Injuries and Disorders | Hand Disease | Wrist DiseasePoland
-
University of California, San FranciscoCompletedOral Lichen Planus | Pemphigus Vulgaris | Mucous Membrane Pemphigoid | Chronic Graft-versus-host-diseaseUnited States
-
University of BelgradeCompleted