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 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT01572168
Eligibility Criteria:
Inclusion Criteria:
* Patients who are ≥ 8 year of age and ≤ 21 years of age who are undergoing chemotherapy and/or radiation therapy for the treatment of any primary or recurrent central nervous system tumor (regardless of diagnosis or disease stage, whether it is malignant or benign, and in any location) at Children's Memorial Hospital.
* Patients who recently completed therapy (within 60 days of enrollment) will also be eligible. Patients must have a minimum baseline fatigue score of 15 on the pedsFACIT-F scale (Range 0-44). This is not a standard assessment for required clinical care and will only be administered by a research assistant to any patient after consent has been obtained. The assessment will be done during a routine clinic visit.
* For patients receiving cytotoxic chemotherapy with a history of myelosuppression or radiation, a hemoglobin concentration of \>8 g/dL measured within 10 days of enrollment and a platelet count of \> 30,000 within 5 days of enrollment is required.
* Patients must also be able to read and understand English and read a computer screen.
* Patients with no known contraindications to acupuncture therapy.
* Patients who are able to attend all scheduled visits for acupuncture.
* Patients must have a Karnofsky Performance Score of ≥ 50% or a Lansky Performance Score of ≥ 50.
* Patients who have provided informed consent for the research study (parental consent for patients \< 18 years of age). Patients between 12 years and 18 years of age must provide assent in additional to parental consents.
Exclusion Criteria:
* Patients with evidence of any cognitive dysfunction that would limit their abilities to report fatigue.
* Patients who have received acupuncture in the previous six weeks.
* Patients with a life expectancy \< 3 months.
* Patients who are pregnant or lactating.
* Patients with a past history of therapy or scheduled visits non-compliance, as determined by their treating physician.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
21 Years
Study:
NCT01572168
Study Brief:
Protocol Section:
NCT01572168