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

• Sponsor: Yunpeng Liu (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03601871
• Collaborator: (none)
• Enrollment: 880
• Locations: 29
• Arms: 2
• Anticipated Duration (Months): 29.6
• Patients Per Site: 30.3
• Patients Per Site Per Month: 1

Study Details

Study Description

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) .

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy-induced Nausea and Vomiting	Drug: Thalidomide; Drug: Dexamethasone; Drug: 5-HT3 antagonists	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 880 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The Efficacy and Safety of Thalidomide in Preventing Multi-cycle, Cisplatin-containing CINV: a Pragmatic Randomized Open-label Clinical Trial
• Actual Study Start Date: Jul 12, 2018
• Anticipated Primary Completion Date: Jun 30, 2020
• Anticipated Study Completion Date: Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control group 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.	Drug: Dexamethasone; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4; Drug: 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; Other Names: Palonosetron, or 1st-generation 5-HT3 antagonists
Experimental: Thalidomide group 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.	Drug: Thalidomide; Thalidomide (Thalidomide Oral Product)100 mg by mouth twice a day on days 1-5 after chemotherapy .; Drug: Dexamethasone; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4; Drug: 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; Other Names: Palonosetron, or 1st-generation 5-HT3 antagonists

Outcome Measures

Primary Outcome Measures

1. No nausea （self report sclae VAS=0）rate in delayed phase (Days2-7) in the first cycle chemotherapy [Day 2-7 in the first chemotherapy cycle(each cycle is 21 days)]

   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).

Secondary Outcome Measures

1. 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 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).

2. 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 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.

3. 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 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)

4. 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 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）

5. 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)]

   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）

6. Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 in multi-cycle chemotherapy [Day 1-21 in each cycle(each cycle is 21 days) during 4-6 chemotherapy cycles (each cycle is 21 days)]

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

7. The quality of life scores (evaluated with Functional Living Index-Emesis (FLIE) questionnaire) of patients when receiving multi-cycle chemotherapy [Day 1-8 in each cycle(each cycle is 21 days) during 4-6 chemotherapy cycles.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	cancer hospital of Haerbin Medical University	Haerbin	Heilongjiang	China
2	Siping City Cancer Hospital	Siping	Jilin	China
3	Anshan Hospital of First Hospital of China Medical University	Anshan	Liaoning	China
4	Anshan Tumor Hospital	Anshan	Liaoning	China
5	Central hospital of Dalian	Dalian	Liaoning	China
6	Second Affiliated Hospital of Dalian Medical University	Dalian	Liaoning	China
7	The Fifth Hospital of Dalian City	Dalian	Liaoning	China
8	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning	China
9	Zhuanghe Central Hospital	Dalian	Liaoning	China
10	Fushun Central Hospital	Fushun	Liaoning	China
11	General Hospital of Mining Bureau	Fushun	Liaoning	China
12	Jinzhou Central Hospital	Jinzhou	Liaoning	China
13	The First Hospital of Liaoning Medical University	Jinzhou	Liaoning	China
14	Chinese Medicine Hospital of Liaoyang county	Liaoyang	Liaoning	China
15	Liaoyang Central Hospital	Liaoyang	Liaoning	China
16	Petrochemical General Hospital of Liaoyang city	Liaoyang	Liaoning	China
17	Panjin central Hospital	Panjin	Liaoning	China
18	Chest Hospital of Shenyang City	Shengyang	Liaoning	China
19	Shengjing Hospital of China Medical University	Shenyang	Liaoning	China	110004
20	General Hospital of Shenyang Military Region	Shenyang	Liaoning	China
21	Liaoning Tumor Hospital & Institute	Shenyang	Liaoning	China
22	The First Hospital of China Medical University	Shenyang	Liaoning	China
23	the People'S Hospital	Shenyang	Liaoning	China
24	Tieling city Central Hospital	Tieling	Liaoning	China
25	Central Hospital of Anshan City	Anshan		China
26	Benxi Central Hospital	Benxi		China
27	Chaoyang Central Hospital	Chaoyang		China
28	Zhongshan Hospital	Dalian		China
29	Liaohe Oilfield General Hospital	Panjin		China

Sponsors and Collaborators

• Yunpeng Liu

Investigators

• Principal Investigator: Yunpeng Liu, PhD. M.D., China Medical University, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yunpeng Liu, Director of Department of Medical Oncology，The First Hospital of China Medical University, China Medical University, China
• ClinicalTrials.gov Identifier: NCT03601871
• Other Study ID Numbers: CLOG1801
• First Posted: Jul 26, 2018
• Last Update Posted: Jul 26, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yunpeng Liu, Director of Department of Medical Oncology，The First Hospital of China Medical University, China Medical University, China: Thalidomide; Chemotherapy-induced Nausea and Vomiting; cisplatin
• Additional relevant MeSH terms: Nausea; Vomiting; Thalidomide; Dexamethasone; Palonosetron; Serotonin 5-HT3 Receptor Antagonists

Study Results

No Results Posted as of Jul 26, 2018