Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and Vomiting
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ClinicalTrials.gov Identifier: NCT02203253 |
Recruitment Status :
Completed
First Posted : July 29, 2014
Last Update Posted : August 24, 2016
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Condition or disease | Intervention/treatment | Phase |
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Neoplasms | Drug: Thalidomide Drug: Placebo for thalidomide Drug: Palonosetron and Dexamethasone | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 642 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and Vomiting From Highly Emetogenic Chemotherapy: a Randomized, Multicenter, Double-blind, Placebo-controlled Phase III Trial |
Study Start Date : | July 2014 |
Actual Primary Completion Date : | July 2016 |
Actual Study Completion Date : | August 2016 |

Arm | Intervention/treatment |
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Active Comparator: Thalidomide Group
Thalidomide 100 mg by mouth twice a day on days 1-5; 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.
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Drug: Thalidomide
100 mg by mouth twice a day on days 1-5 after chemotherapy, cycle 1 Drug: Palonosetron and Dexamethasone 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. |
Placebo Comparator: Placebo Group
Placebo (for Thalidomide) tablet 100 mg by mouth twice a day on days 1-5; 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.
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Drug: Placebo 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
Other Name: Placebo tablet for thalidomide Drug: Palonosetron and Dexamethasone 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. |
- complete response rate (CRR) for delayed CINV [ Time Frame: 120 hours ]
- Adverse Events [ Time Frame: Up to 3 weeks ]
- quality of life [ Time Frame: up to 7 days ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203253
China, Liaoning | |
Anshan Tumor Hospital | |
Anshan, Liaoning, China | |
Second Affiliated Hospital of Dalian Medical University | |
Dalian, Liaoning, China | |
The First Affiliated Hospital of Dalian Medical University | |
Dalian, Liaoning, China | |
The First Hospital of Liaoning Medical University | |
Jinzhou, Liaoning, China | |
Liaoyang Central Hospital | |
Liaoyang, Liaoning, China | |
Petrochemical General Hospital of Liaoyang city | |
Liaoyang, Liaoning, China | |
Third People's hospital Liaoyang | |
Liaoyang, Liaoning, China | |
The First Hospital of China Medical University | |
Shenyang, Liaoning, China, 110001 | |
Shengjing Hospital of China Medical University | |
Shenyang, Liaoning, China, 110004 | |
General Hospital of Shenyang Military Region | |
Shenyang, Liaoning, China | |
Liaoning Tumor Hospital & Institute | |
Shenyang, Liaoning, China |
Principal Investigator: | Yunpeng Liu, MD., PhD | China Medical University, China |
Responsible Party: | Yunpeng Liu, M.D.,PhD, China Medical University, China |
ClinicalTrials.gov Identifier: | NCT02203253 |
Other Study ID Numbers: |
CLOG1302 |
First Posted: | July 29, 2014 Key Record Dates |
Last Update Posted: | August 24, 2016 |
Last Verified: | August 2016 |
solid tumor chemotherapy-induced delayed nausea and vomiting thalidomide prevention |
Nausea Vomiting Signs and Symptoms, Digestive Thalidomide Dexamethasone Palonosetron Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
Antineoplastic Agents, Hormonal Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Serotonin 5-HT3 Receptor Antagonists Serotonin Antagonists Serotonin Agents Neurotransmitter Agents |