Neoplasms
Conditions
Keywords
solid tumor, chemotherapy-induced delayed nausea and vomiting, thalidomide, prevention
Brief summary
This study was aimed to evaluate efficacy and tolerability of thalidomide in improving prevention of chemotherapy-induced delayed nausea and vomiting in chemotherapy-naive patients after highly emetogenic chemotherapy.
Detailed description
This is a prospective, randomized, multi-center, double-blind, placebo-controlled clinical trial, aimed to evaluate efficacy and tolerability of thalidomide in improving prevention of chemotherapy-induced delayed nausea and vomiting (CINV) in chemotherapy-naive patients after highly emetogenic chemotherapy(HEC) (cisplatin-based regimen or cyclophosphamide combination with doxorubicin/epirubicin). A total of 820 patients are planned to be enrolled into the study. Patients treating with highly emetogenic chemotherapy will be randomized into two groups, and be treated with Thalidomide+ Palonosetron+ Dexamethasone or Placebo + Palonosetron+ Dexamethasone, respectively. The primary end point is complete response rate (CRR) for delayed CINV, and the secondary end points include the safety and quality of life (QOL).
Interventions
DRUGThalidomide
100 mg by mouth twice a day on days 1-5 after chemotherapy, cycle 1
DRUGPlacebo for thalidomide
Placebo tablet manufactured to mimic Thalidomide 25 mg tablet 100 mg by mouth twice a day on days 1-5 after chemotherapy , cycle 1
Palonosetron 0.25 mg intravenously on day 1; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4; cycle 1.
Sponsors
The First Hospital of Liaoning Medical University
The First Affiliated Hospital of Dalian Medical University
The Second Affiliated Hospital of Dalian Medical University
Liaoning Cancer Hospital & Institute
Shengjing Hospital
General Hospital of Shenyang Military Region
Liaoyang Central Hospital
Third People's hospital Liaoyang
Petrochemical General Hospital of Liaoyang city
Anshan Tumor Hospital
China Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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 * Cancer patients scheduled to receive HEC regimen. The HEC regimen was defined as chemotherapy containing a 50 mg/m2 or higher dose of cisplatin, or cyclophosphamide combination with doxorubicin/epirubicin
Exclusion criteria
* Diabetic patients * Pregnant or lactated women * Patient with history of thrombosis * Concomitant radiotherapy * Known hypersensitivity to 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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response rate (CRR) for delayed CINV | 120 hours |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events | Up to 3 weeks |
| quality of life | up to 7 days |
Countries
China
Outcome results
None listed