Clinical trial NCT03601871: The Efficacy and Safety of Thalidomide in Preventing CINV Induced by Cisplatin-containing Chemotherapy
Official title: The Efficacy and Safety of Thalidomide in Preventing Multi-cycle, Cisplatin-containing CINV: a Pragmatic Randomized Open-label Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chemotherapy-induced Nausea and Vomiting
Keywords: Thalidomide
Chemotherapy-induced Nausea and Vomiting
cisplatin
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 880
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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) .

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.

Eligibility criteria: 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

Primary outcomes:
measure: No nausea （self report sclae VAS=0）rate in delayed phase (Days2-7) in the first cycle chemotherapy
timeFrame: Day 2-7 in the first chemotherapy cycle(each cycle is 21 days)
Secondary outcomes:
measure: No nausea rates （VAS=0）for delayed phases (Days2-7) during 2nd to 4th or 6th chemotherapy cycle,respectively.
timeFrame: Day 2-7 in each chemotherapy cycle (each cycle is 21 days)
measure: 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.
timeFrame: Day 1-7 in 4-6 cycles(each cycle is 21 days)
measure: The rate of no anorexia (VAS=0) and score of anorexia (assessed by VAS) in Day1-7 during 1st-4th or 6th cycle chemotherapy
timeFrame: Day 1-7 in each cycle(each cycle is 21 days)
measure: The score of fatigue by VAS in day1-7 in1st to 4th or 6th chemotherapy cycle,respectively.
timeFrame: Day 1-7 in each cycle(each cycle is 21 days)
measure: The score of sedation(by self-report VAS) in day 1-7 in each cycle
timeFrame: Day 1-7 in each cycle(each cycle is 21 days)
measure: Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 in multi-cycle chemotherapy
timeFrame: Day 1-21 in each cycle(each cycle is 21 days) during 4-6 chemotherapy cycles (each cycle is 21 days)
measure: The quality of life scores (evaluated with Functional Living Index-Emesis (FLIE) questionnaire) of patients when receiving multi-cycle chemotherapy
timeFrame: Day 1-8 in each cycle(each cycle is 21 days) during 4-6 chemotherapy cycles.
Other outcomes:
Locations:
city: Haerbin
country: China
facility: cancer hospital of Haerbin Medical University
state: Heilongjiang
city: Siping
country: China
facility: Siping City Cancer Hospital
state: Jilin
city: Anshan
country: China
facility: Anshan Hospital of First Hospital of China Medical University
state: Liaoning
city: Anshan
country: China
facility: Anshan Tumor Hospital
state: Liaoning
city: Dalian
country: China
facility: Central hospital of Dalian
state: Liaoning
city: Dalian
country: China
facility: Second Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Dalian
country: China
facility: The Fifth Hospital of Dalian City
state: Liaoning
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Dalian
country: China
facility: Zhuanghe Central Hospital
state: Liaoning
city: Fushun
country: China
facility: Fushun Central Hospital
state: Liaoning
city: Fushun
country: China
facility: General Hospital of Mining Bureau
state: Liaoning
city: Jinzhou
country: China
facility: Jinzhou Central Hospital
state: Liaoning
city: Jinzhou
country: China
facility: The First Hospital of Liaoning Medical University
state: Liaoning
city: Liaoyang
country: China
facility: Chinese Medicine Hospital of Liaoyang county
state: Liaoning
city: Liaoyang
country: China
facility: Liaoyang Central Hospital
state: Liaoning
city: Liaoyang
country: China
facility: Petrochemical General Hospital of Liaoyang city
state: Liaoning
city: Panjin
country: China
facility: Panjin central Hospital
state: Liaoning
city: Shengyang
country: China
facility: Chest Hospital of Shenyang City
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: General Hospital of Shenyang Military Region
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Tumor Hospital & Institute
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: the People'S Hospital
state: Liaoning
city: Tieling
country: China
facility: Tieling city Central Hospital
state: Liaoning
city: Anshan
country: China
facility: Central Hospital of Anshan City
city: Benxi
country: China
facility: Benxi Central Hospital
city: Chaoyang
country: China
facility: Chaoyang Central Hospital
city: Dalian
country: China
facility: Zhongshan Hospital
city: Panjin
country: China
facility: Liaohe Oilfield General Hospital
Study officials:
affiliation: China Medical University, China
name: Yunpeng Liu, PhD. M.D.
role: PRINCIPAL_INVESTIGATOR
References: