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The Efficacy and Safety of Thalidomide in Preventing CINV Induced by Cisplatin-containing Chemotherapy | Clinical Trials | Clareo Health

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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

NCT03601871•Yunpeng Liu

View on ClinicalTrials.gov

Summary

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

Locations (29)

cancer hospital of Haerbin Medical University

Haerbin, Heilongjiang, China

Siping City Cancer Hospital

Siping, Jilin, China

Anshan Hospital of First Hospital of China Medical University

Anshan, Liaoning, China

Anshan Tumor Hospital

Anshan, Liaoning, 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

Zhuanghe Central Hospital

Dalian, Liaoning, China

Fushun Central Hospital

Fushun, Liaoning, China

Key Dates

Start Date

July 12, 2018

Primary Completion Date

June 30, 2020

Completion Date

December 30, 2020

Last Updated

July 26, 2018

Enrollment

880

ESTIMATED participants

Conditions

Chemotherapy-induced Nausea and Vomiting

Interventions

Thalidomide

DRUG

Dexamethasone

DRUG

5-HT3 antagonists

DRUG

Contacts

Xiujuan Qu, PhD. M.D.

CONTACT

024-83282542 qu_xiujuan@hotmail.com

Lingyun Zhang, PhD. M.D.

CONTACT

024-83282312 zhangly1105@126.com

A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC

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Chemotherapy-induced Nausea and Vomiting

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A Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting

NCT01937156

Chemotherapy-induced Nausea and Vomiting

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Granisetron Transdermal Patch for Prophylaxis of Nausea and Vomiting in Patients Receiving Oral Anticancer Agents

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 26, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC

A Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting

Granisetron Transdermal Patch for Prophylaxis of Nausea and Vomiting in Patients Receiving Oral Anticancer Agents

Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Healthy Adult Volunteers

Granisetron Extended Release Injection (GERSC) for the Prevention of Chemotherapy-induced Nausea and Vomiting

A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination for the Prevention of CINV in AC Chemotherapy in Women With Breast Cancer