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:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT02532634
Eligibility Criteria:
Inclusion Criteria:
* The patient's age is ≥ 19 years old
* Histologically or cytologically confirmed solid tumor
* Patients diagnosed as malignancy who will be treated with highly emetogenic chemotherapeutic agents (NCCN guideline v2.0, 2014 anti-emesis). (Cisplatin dosage is over 50mg/m2, combination therapy is available with other chemotherapeutic agents and including lymphoma)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Available oral administration of study drugs
* Adequate organ functions as follows: 1) Hematologic - white blood cell count (WBC) ≥ 3000 microliter (microL) or Neutrophil≥ 1500 micro/L, Platelet ≥ 100,000/microL; 2) Serum Creatinine ≤ 1.5 times upper limit of normal; 3) Hepatic function - Total bilirubin, AST, ALT ≤2.5 times upper limit of normal, ALP ≤ 2 times upper limit of normal( except ALP increasing due to bone metastasis
* Patients with normal range of serum K, Mg and hold serum Ca over lower limit of normal range
* Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital
Exclusion Criteria:
* Patients with severe Hypertension, severe Heart disease, congenital long QT syndrome, bradyarrhythmia severe kidney disease(serum creatinine≥3㎎/㎗), liver disease (AST, ALT ≥ 2.5 times of upper normal range, ALP ≥ 2 times of upper normal range)
* Patients with GI obstruction, active gastric ulcer or other diseases that could provoke nausea and vomiting
* Patients who have nausea and vomiting within 1 week before chemotherapy
* Patients who should take steroid, antiemetics, antipsychotic agent including benzodiazepine, pimozide, terfenadine, astemizole, cisapride, rifampin, carbamazepine, phenytoin, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir or nelfinavir, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors for the treatment of other diseases
* Patients with brain tumor, brain metastasis or seizure
* Patients receiving chemotherapy within 6 months before enrollment
* Patients who need radiation therapy during study period or receiving radiation therapy within 2 weeks before chemotherapy
* Patients who have known allergy or severe side effect on study drugs(5-HT3 antagonist and aprepitant)
* Pregnant or lactating women, or women who wish to become pregnant
* Patients with drug abuse, a mental disease and difficult to communicate with investigators
* Others whom the investigator judges inappropriate as subjects for this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02532634
Study Brief:
Protocol Section:
NCT02532634