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Nk-1 receptor antagonist, 5-ht3 receptor antagonist and dexamethasone antiemetic regimen to prevent nausea and vomiting induced by chemotherapy drugs with high emetic risk for several days

Nk-1 receptor antagonist, 5-ht3 receptor antagonist and dexamethasone antiemetic regimen to prevent nausea and vomiting induced by chemotherapy drugs with high emetic risk for several days

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024816
Enrollment
Unknown
Registered
2019-07-29
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

Breast cancer, soft tissue cancer, stomach cancer, bowel cancer, liver cancer, lung cancer, cervical cancer,

Interventions

single arm:Nk-1 receptor antagonist, 5-ht3 receptor antagonist and dexamethasone antiemetic regimen

Sponsors

Affiliated Tumor Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patient aged 18 to 70 years male or females; 2. Patient with ECOG =90 g/L,WBC>=3.0x10^9/L,ANC>=1.5x10^9/L, PLT>=80x10^9/L; TBIL50 ml/min (Cockcroft-Gault formula); 8. Last cycle of chemotherapy was completed >=3 weeks prior to baseline; 9. Women of childbearing age are willing to using appropriate methods of contraception during the test and 8 weeks after having the last experimental drug, and should have a pregnancy check before test if necessary, the result should be negative; 10. Patient were willing to join in this study, sign the informed consent, good adherence, and cooperate with the follow-up.

Exclusion criteria

Exclusion criteria: 1. Pregnant or nursing female patient; need radiotherapy during our study going on; 2. Patient with gastrointestinal tract obstruction; 3. Patient with seriously heart disease, liver and kidney diseases, or metabolic dysfunction; 4. Patient with epilepsy, or using psychiatric drugs or sedative; 5. Patient Used antiemeticwithin 24hours of starting the study treatment, or vomited before chemotherapy; 6. Patient with metastatic brain tumor, vomitingbecause of intracranial hypertension; 7. Patient with irritability of 5-HT3 receptor antagonist; 8. Patient with Contraindications on chemotherapy; 9. Being or 4 weeks prior to the starting of the study involved in other drug clinical trial.

Design outcomes

Primary

MeasureTime frame
According to the international evaluation system for adverse reactions to chemotherapy drugs (CTCAE) version 4.03. Nausea is defined as a condition characterized by nausea and/or an urgent need for vomiting.;Complete remission rate (CR): number of CINV complete remission patients/number of chemotherapy patients x100%; CINV complete remission was defined as (CTCAE) version 4.03, nausea and vomiting grade 0 (no nausea and vomiting).;Adverse reactions: adverse events and laboratory tests were graded according to NCI CTC AE 4.0, and special attention should be paid to early withdrawal from the study as well as vital signs (such as blood pressure, body temperature, etc.), intestinal obstruction, intractable hiccups, uncontrollable headaches, etc.;

Countries

China

Contacts

Public ContactXie Weimin

Affiliated Tumor Hospital of Guangxi Medical University

dd.xie@qq.com+86 13907861028

Outcome results

None listed

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