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) .
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
880
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
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).
Time frame: Day 2-7 in the first chemotherapy cycle(each cycle is 21 days)
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).
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.
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.
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
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)
Time frame: Day 1-7 in each cycle(each cycle is 21 days)
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cancer hospital of Haerbin Medical University
Haerbin, Heilongjiang, China
NOT_YET_RECRUITINGSiping City Cancer Hospital
Siping, Jilin, China
NOT_YET_RECRUITINGAnshan Hospital of First Hospital of China Medical University
Anshan, Liaoning, China
NOT_YET_RECRUITINGAnshan Tumor Hospital
Anshan, Liaoning, China
NOT_YET_RECRUITINGCentral hospital of Dalian
Dalian, Liaoning, China
NOT_YET_RECRUITINGSecond Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
NOT_YET_RECRUITINGThe Fifth Hospital of Dalian City
Dalian, Liaoning, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
NOT_YET_RECRUITINGZhuanghe Central Hospital
Dalian, Liaoning, China
NOT_YET_RECRUITINGFushun Central Hospital
Fushun, Liaoning, China
RECRUITING...and 19 more locations
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)
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
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)
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
Number of participants with Treatment-Related Adverse Events as assessed by CTCAE v4.0, in 4-6 cycles (each cycle is 21 days).
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
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.
Time frame: Day 1-8 in each cycle(each cycle is 21 days) during 4-6 chemotherapy cycles.