Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT01909856
Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with malignant tumors who can receive 3-day chemotherapy regimens defined by the protocol;
* The two-cycle sequential chemotherapy must be the same in drugs, dosage, sequence and routes of administration;
* Patients are prohibited from any other chemotherapy drugs during the study, as well as other antiemesis, sedative and psychotropic drugs within 5 days after chemotherapy;
* Life expectancy ≥ 3 months;
* Adequate hematologic function;
* Adequate hepatic function;
* Adequate renal function;
* At least 2 weeks away from the last chemotherapy;
* Patients signed written informed consent.
Exclusion Criteria:
* Pregnant or lactating women;
* History of anticipatory vomiting;
* Radiation therapy on the abdomen or pelvis within one week prior to study entry;
* Concomitant use of other drugs which may affect the antiemetic effects (such as omeprazole, amifostine, etc.);
* Patients with gastrointestinal obstruction;
* Patients with severe heart disease, liver or renal disease, or metabolism disorders;
* Patients with epilepsy or using sedative or psychotropic drugs;
* Patients with diabetes or with contraindication for corticosteroids;
* Patients who received antiemetic drugs or experienced nausea or vomiting within 24 hours prior to study entry;
* Patients with brain metastasis or intracranial hypertension;
* Hypersensitivity to 5-HT3 receptor antagonist;
* Patients with active infection;
* Other conditions that the investigator considered as unsuitable for chemotherapy;
* Subjects participating in other clinical trials.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01909856
Study Brief:
Protocol Section:
NCT01909856