The Efficacy and Safety of Thalidomide in Preventing CINV Induced by Cisplatin-containing Chemotherapy
1 other identifier
interventional
880
1 country
29
Brief Summary
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) .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2018
Typical duration for not_applicable
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2018
CompletedStudy Start
First participant enrolled
July 12, 2018
CompletedFirst Posted
Study publicly available on registry
July 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedJuly 26, 2018
July 1, 2018
2 years
May 30, 2018
July 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
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.
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.
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
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.
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
Day 1-7 in each cycle(each cycle is 21 days)
- +2 more secondary outcomes
Study Arms (2)
Control group
ACTIVE COMPARATORPalonosetron 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
EXPERIMENTALThalidomide 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.
Interventions
Thalidomide (Thalidomide Oral Product)100 mg by mouth twice a day on days 1-5 after chemotherapy .
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
Eligibility Criteria
You may qualify if:
- y ≤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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yunpeng Liulead
Study Sites (29)
cancer hospital of Haerbin Medical University
Haerbin, Heilongjiang, China
Siping City Cancer Hospital
Siping, Jilin, China
Anshan Hospital of First Hospital of China Medical University
Anshan, Liaoning, China
Anshan Tumor Hospital
Anshan, Liaoning, China
Central hospital of Dalian
Dalian, Liaoning, China
Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
The Fifth Hospital of Dalian City
Dalian, Liaoning, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Zhuanghe Central Hospital
Dalian, Liaoning, China
Fushun Central Hospital
Fushun, Liaoning, China
General Hospital of Mining Bureau
Fushun, Liaoning, China
Jinzhou Central Hospital
Jinzhou, Liaoning, China
The First Hospital of Liaoning Medical University
Jinzhou, Liaoning, China
Chinese Medicine Hospital of Liaoyang county
Liaoyang, Liaoning, China
Liaoyang Central Hospital
Liaoyang, Liaoning, China
Petrochemical General Hospital of Liaoyang city
Liaoyang, Liaoning, China
Panjin central Hospital
Panjin, Liaoning, China
Chest Hospital of Shenyang City
Shengyang, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
General Hospital of Shenyang Military Region
Shenyang, Liaoning, China
Liaoning Tumor Hospital & Institute
Shenyang, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
the People'S Hospital
Shenyang, Liaoning, China
Tieling city Central Hospital
Tieling, Liaoning, China
Central Hospital of Anshan City
Anshan, China
Benxi Central Hospital
Benxi, China
Chaoyang Central Hospital
Chaoyang, China
Zhongshan Hospital
Dalian, China
Liaohe Oilfield General Hospital
Panjin, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yunpeng Liu, PhD. M.D.
China Medical University, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of Department of Medical Oncology，The First Hospital of China Medical University
Study Record Dates
First Submitted
May 30, 2018
First Posted
July 26, 2018
Study Start
July 12, 2018
Primary Completion
June 30, 2020
Study Completion
December 30, 2020
Last Updated
July 26, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share