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

NCT03601871 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 880

Last updated 2018-07-26

No results posted yet for this study

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) .

Conditions

  • Chemotherapy-induced Nausea and Vomiting

Interventions

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

Sponsors & Collaborators

  • Yunpeng Liu

    lead OTHER

Principal Investigators

  • Yunpeng Liu, PhD. M.D. · China Medical University, China

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-12
Primary Completion
2020-06-30
Completion
2020-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03601871 on ClinicalTrials.gov