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

Chemotherapy-induced Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03601871
• Other study ID #: CLOG1801
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: July 2018
• Source: China Medical University, China
• Contact: Xiujuan Qu, PhD. M.D.
• Phone: 024-83282542
• Email: qu_xiujuan[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 880
• Est. completion date: December 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Drug:
• Thalidomide
Thalidomide (Thalidomide Oral Product)100 mg by mouth twice a day on days 1-5 after chemotherapy .
• Dexamethasone
Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4
• 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

Locations

Country	Name	City	State
China	Anshan Hospital of First Hospital of China Medical University	Anshan	Liaoning
China	Anshan Tumor Hospital	Anshan	Liaoning
China	Central Hospital of Anshan City	Anshan
China	Benxi Central Hospital	Benxi
China	Chaoyang Central Hospital	Chaoyang
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	Zhongshan Hospital	Dalian
China	Zhuanghe Central Hospital	Dalian	Liaoning
China	Fushun Central Hospital	Fushun	Liaoning
China	General Hospital of Mining Bureau	Fushun	Liaoning
China	cancer hospital of Haerbin Medical University	Haerbin	Heilongjiang
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	Liaohe Oilfield General Hospital	Panjin
China	Panjin central Hospital	Panjin	Liaoning
China	Chest Hospital of Shenyang City	Shengyang	Liaoning
China	General Hospital of Shenyang Military Region	Shenyang	Liaoning
China	Liaoning Tumor Hospital & Institute	Shenyang	Liaoning
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	the People'S Hospital	Shenyang	Liaoning
China	Siping City Cancer Hospital	Siping	Jilin
China	Tieling city Central Hospital	Tieling	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Yunpeng Liu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	Day 2-7 in each chemotherapy cycle (each cycle is 21 days)
Secondary	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.	Day 1-7 in 4-6 cycles(each cycle is 21 days)
Secondary	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)	Day 1-7 in each cycle(each cycle is 21 days)
Secondary	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)	Day 1-7 in each cycle(each cycle is 21 days)
Secondary	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)	Day 1-7 in each cycle(each cycle is 21 days)
Secondary	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).	Day 1-21 in each cycle(each cycle is 21 days) during 4-6 chemotherapy cycles (each cycle is 21 days)
Secondary	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.	Day 1-8 in each cycle(each cycle is 21 days) during 4-6 chemotherapy cycles.