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 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 12:35 AM
NCT ID:
NCT01346267
Eligibility Criteria:
INCLUSION CRITERIA:
* 4 to 18 years of age, inclusive. The patient's cognitive ability must be considered by a parent or healthcare professional to be at least at a 4 year-old level.
* Newly diagnosed (i.e., not relapsed) with any malignancy.
* Patients are not required to be registered on a COG therapeutic trial.
* The patient's current chemotherapy treatment plan must include at least 1 course of
* cisplatin at ≥ 50 mg/m2/dose or
* ifosfamide plus etoposide or doxorubicin or
* cyclophosphamide plus an anthracycline.
* Patients may have previously received other chemotherapy.
* The patient's current treatment plan must include an anti-emetic regimen with either ondansetron or granisetron on a scheduled basis. Patients may also receive dexamethasone for antiemetic prophylaxis during the acute phase at the discretion of the treating physician. Patients ≥ 12 years old may also receive aprepitant in conjunction with dexamethasone for antiemetic prophylaxis at the discretion of the treating physician.
* Patients needing anti-emetic treatment for breakthrough nausea/vomiting may also receive anti-emetic agents on an as needed (PRN) basis.
* The patient (parent/guardian) must be English-speaking (i.e., able to read and speak in English) since the PeNAT has been validated only in English.
* All patients and/or their parents or legal guardians must sign a written informed consent (patient assent is also recommended when applicable according to each institution's policy).
EXCLUSION CRITERIA:
* Prior history of acupressure use.
* Scheduled use of antiemetic agents other than ondansetron, granisetron, dexamethasone or aprepitant. Patients may receive other antiemetic agents PRN for breakthrough nausea/vomiting but not on a scheduled basis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
18 Years
Study:
NCT01346267
Study Brief:
Protocol Section:
NCT01346267