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Randomized controlled study of the combination regimen of Thalidomide and olanzapine + 5-HT receptor antogonist + hormonotherapy for the prevention of delayed nausea and vomiting induced by highly emetogenic chemotherapy

Randomized controlled study of the combination regimen of Thalidomide and olanzapine + 5-HT receptor antogonist + hormonotherapy for the prevention of delayed nausea and vomiting induced by highly emetogenic chemotherapy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045323
Enrollment
Unknown
Registered
2021-04-12
Start date
2021-04-15
Completion date
Unknown
Last updated
2021-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy

Interventions

Thalidomide group:Thalidomide 100mg qd1-5
Olanzapine group:Olanzapine 10mg d1-4

Sponsors

Hainan General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Patients were age 18 to 70 years who had not received previous chemotherapy; 2.Highly emetogenic chemotherapy regimen: cisplatin >=50 mg/m^2 plus or without other chemotherapy drugs; Doxorubicin 60 mg/m^2, or epirubicin >= 80 mg/m^2+ cyclophosphamide 600 mg/m^2; 3.ECOG performance status of 0, 1, or 2; 4.Life expectancy of at least 12 weeks; 5.Women who were of childbearing age were required to have a pregnancy test with negative results performed within 7 days before enrollment; 6.Bone marrow, liver and kidney function can tolerate chemotherapy (creatinine < 117 UMOL/L, AST, ALT no more than 3 times the normal value); 7.Absolute neutrophil count of at least 15000 per cubic millimeter; 8.Patients (or its legal representative) signed the informed consent form, showed that understand the purpose of research and process requirements, and willing to participate in this study.

Exclusion criteria

Exclusion criteria: 1.Nausea or vomiting within 24 h before enrollment; 2.Gastric pyloric obstruction or intestinal obstruction; 3.Severe electrolyte disorder; 4.Known history of CNS disease or severe cognitive compromise; 5.Symptomatic brain metastasis or suspected clinical brain metastasis; 6.Known uncontrolled congestive heart failure, cardiac arrhythmia, or acute myocardial infarction within the previous 6 months; 7.History of uncontrolled peptic ulcer, diabetes mellitus or other hormone therapy contraindications; 8.History of symptomatic thrombosis; history or suspected likelihood of using narcotic analgesics; treatment with CHOP, pemetrexed, or taxane-based regimen; concurrent administration of any other drug that affects the evaluation of an antiemetic effect; 9.Concurrent abdominal radiotherapy; 10.Inability to take or absorb oral medicine; 11.Other conditions unsuitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
The delayed vomiting was completely relieved;

Secondary

MeasureTime frame
Early onset or full remission of vomiting;No incidence of nausea;

Countries

China

Contacts

Public ContactZeng Aihui

Hainan General Hospital

zahui238@126.com+86 187899407331

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026