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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT04085393
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of malignant disease and scheduled for MEC or HEC
* Chemotherapy naive
* Age ≥18 years.
* ECOG Performance Status 0 or 1
* Required Initial Laboratory Values ≤28 days prior to registration. Patient must have adequate bone marrow, kidney, and liver function as evidenced by:
* Platelet count ≥ 100,000/ mm3
* Bilirubin ≤ 1.5 x ULN, except for subjects with Gilbert's syndrome
* Serum Creatinine ≤2.0 mg/dL
* SGOT or SGPT ≤3 x upper limit of normal (ULN)
* Absolute neutrophil count (ANC) ≥1500/mm3
* Patients receiving HEC will have received the 5HT3 receptor antagonist palonosetron, a NK-1, and dexamethasone as antiemetic prophylaxis during cycle 1 of chemotherapy
* Patients receiving MEC will have received the 5HT3 receptor antagonist palonosetron, and dexamethasone as antiemetic prophylaxis during cycle 1 of chemotherapy
Exclusion Criteria:
* No nausea or vomiting ≤ 24 hours prior to registration.
* Negative pregnancy test (serum β hCG) done ≤7 days prior to registration, for women of childbearing potential only (per clinician discretion).
* No severe cognitive compromise.
* No known history of active, untreated CNS disease (e.g. brain metastases, seizure disorder).
* No concurrent use of amifostine, thioridazine, pimozide or St. John's wort.
* No concurrent abdominal radiotherapy.
* No concurrent use of olanzapine therapy.
* No chronic alcoholism (as determined by the investigator).
* No known hypersensitivity to granisetron.
* No known uncontrolled cardiac arrhythmia or uncontrolled congestive heart failure.
* No acute myocardial infarction within the previous six months.
* No history of uncontrolled diabetes mellitus (may be on a stable dose of insulin or on a stable dose of an oral hypoglycemic agent).
* Patients with psychiatric illness that would prevent the patient from giving informed consent are not eligible for the trial
* Medical condition such as uncontrolled infection (including HIV),uncontrolled Diabetes Mellitus, unstable cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient are not eligible for the trial
* Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not eligible for the trial; Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years.
* Patients who cannot swallow oral formulations of the agent(s) are not eligible for the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04085393
Study Brief:
Protocol Section:
NCT04085393