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Single-arm, multicenter, observational study of thalidomide, 5-HT3 receptor antagonist combined with dexamethasone regimen for the prevention of delayed vomiting caused by highly/moderately emetogenic chemotherapy in Hainan cancer patients

Single-arm, multicenter, observational study of thalidomide, 5-HT3 receptor antagonist combined with dexamethasone regimen for the prevention of delayed vomiting caused by highly/moderately emetogenic chemotherapy in Hainan cancer patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100046657
Enrollment
Unknown
Registered
2021-05-26
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-01-04

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

Conditions

Chemotherapy-associated vomiting

Interventions

observation group:Observational Study, No intervention

Sponsors

The Second Affiliated Hospital of Hainan Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Malignant tumor patients receiving their first chemotherapy regimen. Any type of cancer, but histological diagnosis is necessary. 2. Ages 18-70 years, regardless of gender. 3. Patients receiving highly emetic chemotherapy. 4. Patients receiving moderately emetic chemotherapy must have at least 2 risk factors chemotherapy-associated vomiting, including female, young patients (age < 50 years), drinking little or no alcohol, medical history of motion sickness (carsickness, seasickness, airsickness), medical history of vomiting during pregnancy, anxiety, expecting to have severe adverse reactions before chemotherapy, concomitant medications (e.g., opioid analgesics, serotonin reuptake inhibitors, etc.). 5. Physical condition (ECOG) scores 0-2 points, and survival is expected to be more than 3 months. 6. Blood routine (WBC, ANC, RBC, Hb, PLT), liver function (ALT, AST, ALP, LDH, TBil, DBil), renal function (Cr, BUN), electrolyte (K, Na, Cl, Ca, P, Mg), blood glucose, electrocardiogram, cardiac function and coagulation function are examined basically normally, which conforming to the indications of chemotherapy. 7. The pregnancy test of female patients was negative. 8. All patients have no family planning within 3 years and take contraceptive measures. 9. Patients were not treated with antiemetic, sedative or psychotropic drugs (such as cimetidine, diazepam, promethazine, anti-anxiety or anti-depression drugs, metoclopramide, etc.) or glucocorticoid therapy other than the regimen on the 1st to 5th day of the chemotherapy cycle. 10. The patient participates voluntarily and signs the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with diabetes history. 2. Lactating and pregnant women. 3. Patients with a history of thrombosis. 4. Patients who also receives radiotherapy such as abdominal or pelvic radiotherapy effecting the observation of antiemetic effect. 5. Accompanied by the application of drugs that may affect the antiemetic effect (such as omeprazole, cimetidine, amphotin). 6. Glucocorticoid users who receive the dose other than that specified in this study (such as chemotherapy regimen containing taxus users, long-term glucocorticoid users). 7. Severe heart disease, liver disease, kidney disease, or metabolic dysfunction. 8. Patients who have used antiemetic drugs or vomite before chemotherapy within 24 hours, such as those with digestive tract obstruction. 9. Patients suffering from central nervous system diseases, brain metastases or intracranial hypertension which induces vomiting or disorder of disease description or influences the observation of adverse reaction. Patients suffering from epilepsy or taking antipsychotic or sedative drugs. 10. Allergic to 5-HT3 receptor antagonists. 11. Allergic to thalidomide. 12. Patients with contraindications to chemotherapy. 13. Participating in clinical trials of other new drugs.

Design outcomes

Primary

MeasureTime frame
the control rate of delayed vomiting (24-120 hours after chemotherapy);

Secondary

MeasureTime frame
safty;quality of life;

Countries

China

Contacts

Public ContactHaifeng Lin

The Second Affiliated Hospital of Hainan Medical University

13322060949@163.com+86 13322060949

Outcome results

None listed

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