Patients will be administered with dexamethasone plus tropisetron from D1 to D3.
Patients will also be administrated with placebos from D1-D4

Patients will receive a regimen with dexamethasone plus tropisetron from D1-D3. Patients will also be administrated with olanzapine from D1-D4.

Chemotherapy-induced Nausea and Vomiting

Lung Cancer

Dexamethasone (10mg/d) (Days1-3) Tropisetron (4mg or 4.48mg or 5mg /d) (Days1-3) Olanzapine (10mg/d) (Days1-4)

Olanzapine

Dexamethasone (10mg/d) (Days1-3) Tropisetron (4mg or 4.48mg or 5mg /d) (Days1-3) Placebos (Days1-4)

Placebos

Affiliated Hospital of Zunyi Medical University

Afﬁliated Hospital of North Sichuan Medical College

Olanzapine for the Prevention and Treatment of Nausea and Vomiting Induced by Chemotherapy of Lung Cancer

Olanzapine as First Line Treatment for Prevention of Nausea and Vomiting Induced by Chemotherapy of Lung Cancer: a Multicenter, Double-blind and Randomized Trial

Number of participants with nausea and vomiting occuring within 24 hours after chemotherapy in all participants.

Number of participants with no nausea and vomiting occuring within 24 hours after chemotherapy as assessed by CTCAE v4.0.

Number of participants with no nausea and vomiting occuring in 24 hours to 120 hours after chemotherapy as assessed by CTCAE v4.0.

Number of participants who reach complete response or partial response.

Quality of life of participants is measured with The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13(QLQ-LC13) scale which is filled by participants themselves. The questionnaire is consist of several symptoms measured by scores range from 1 to 7, the higher the symptoms are scored, the worse the quality of life is.

Quality of life of participants is measured with EORTC QLQ-LC30 scale which is filled by participants themselves. The questionnaire is consist of several symptoms measured by scores range from 1 to 7, the higher the symptoms are scored, the worse the quality of life is.

Quality of life of participants is measured with Functional Assessment of Cancer Therapy-Lung cancer (FACT-L) scale which is filled by participants themselves. The FACT-L, version 4, is a combination of the 27-item FACT-General (FACT-G) and the 9-item Lung Cancer Subscale (LCS) which measures multidimensional quality of life. The FACT-L score ranges from 0 to 136. The higher the score obtained by each patient in question, the greater the final score of the subscale and the better the quality of life.

The individual participant data will be available to other researchers in this study and physicians treating study participants.Jiangsu Famous Medicine Co.,Ltd. provide EDC.

Jian-Guo Zhou,MD

Principal Investigator

Zunyi Medical College

Zunyi First People's Hospital

Sichuan Cancer Hospital and Research Institute

Guizhou Provincial People's Hospital

Affiliated Hospital of Southwest Medical University

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.

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.

Thalidomide (Thalidomide Oral Product)100 mg by mouth twice a day on days 1-5 after chemotherapy .

Thalidomide

Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4

Dexamethasone

Palonosetron 0.25 mg intravenously on day 1; or 1st-generation 5-HT3 antagonists (used as clinal routine) on day 1-3

5-HT3 antagonists

cancer hospital of Haerbin Medical University

Siping City Cancer Hospital

Anshan Hospital of First Hospital of China Medical University

Anshan Tumor Hospital

Central hospital of Dalian

Second Affiliated Hospital of Dalian Medical University

The Fifth Hospital of Dalian City

The First Affiliated Hospital of Dalian Medical University

Zhuanghe Central Hospital

Fushun Central Hospital

General Hospital of Mining Bureau

Jinzhou Central Hospital

The First Hospital of Liaoning Medical University

Chinese Medicine Hospital of Liaoyang county

Liaoyang Central Hospital

Petrochemical General Hospital of Liaoyang city

Panjin central Hospital

Chest Hospital of Shenyang City

Shengjing Hospital of China Medical University

General Hospital of Shenyang Military Region

Liaoning Tumor Hospital & Institute

The First Hospital of China Medical University

the People'S Hospital

Tieling city Central Hospital

Central Hospital of Anshan City

Benxi Central Hospital

Chaoyang Central Hospital

Zhongshan Hospital

Liaohe Oilfield General Hospital

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

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).

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).

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.

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)

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）

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）

Number of participants with Treatment-Related Adverse Events as assessed by CTCAE v4.0, in 4-6 cycles (each cycle is 21 days).

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.

5 hydroxytryptamine/epuizare

Olanzapine for the Prevention and Treatment of Nausea and Vomiting Induced by Chemotherapy of Lung Cancer

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

An Investigation of the Antidepressant Efficacy of the 5-HT2A Antagonist, M100907, in Combination With Citalopram in Treatment Resistant Depression

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