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 @ 12:36 PM
Ignite Modification Date:
2025-12-24 @ 12:36 PM
NCT ID:
NCT01046461
Eligibility Criteria:
Inclusion Criteria:
* 18 -75 years, both sex
* ECOG performance status 0-2
* Histologically proven solid cancer, chemotherapy-naïve patient
* Planed to receive cisplatin (≥ 50mg/m2) based, single day chemotherapy,
* No nausea or vomiting within 72 hours prior to chemotherapy
* Serum Cr \< 2.5 mg/dl, or calculated CCr ≥ 50 ml/min
* Serum total bilirubin \< 2 mg/dl, AST/ALT \< 3 times the upper normal limit , ALP \< 5 times the upper normal limit
* Absolute neutrophil count ≥ 1,500/μL, platelet ≥ 100,000/μL
* Expected life duration ≥ 3 months
* 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 active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, active gastric or duodenal ulcers, or pregnancy or breast-feeding
* Patients who should take steroid, antiemetics, pimozide, terfenadine, astemizole, cisapride, rifampin, carbamazepine, phenytoin, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir or nelfinavir for the treatment of other diseases
* Patients taking any medicine, which could affect study results, within 1 week before chemotherapy (or taking anti-emetics within 48 hours before chemotherapy). Prior to beginning chemotherapy, single-agent benzodiazepines as hypnotic is allowed, but it can't be receiving during day 1-6 of 1st chemotherapy cycle.
* Patients with symptomatic brain metastasis
* Patients with GI obstruction or other diseases that could provoke nausea and vomiting
* Patients receiving RT on brain, abdomen or pelvis within 2 weeks before chemotherapy
* Patients who cannot understand informed consent or express his/her condition
* Patients who cannot swallow drugs
* Patients who have known allergy or severe side effect on study drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01046461
Study Brief:
Protocol Section:
NCT01046461