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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT00658034
Eligibility Criteria:
Inclusion Criteria:
* Patients age 18-64 diagnosed with a malignancy (solid tumor or hematologic malignancy).
* Patients must have received chemotherapy.
* Patients must complain of fatigue following chemotherapy buy not prior to chemotherapy.
* At least 60 days must have elapsed between the last chemotherapy infusion and completion of the first baseline questionnaire.
* Mean baseline fatigue as measured by the Brief Fatigue Inventory must be four or above.
Exclusion Criteria:
* Anemia, defined as Hb\<9 or active treatment for anemia. Iron supplementation is allowed as long as the dose has been stable for at least six weeks.
* Platelets less than 50,000/microliter or an Absolute Neutrophil Count less than 1,000/microliter.
* Baseline depression score on the Hospital Anxiety and Depression Scale of 11 or above, indicating clinical depression.
* Thyroid disorder, defined as either thyroid stimulating hormone or free T4 out of normal range, is excluded as it is a possible cause of fatigue unrelated to cancer therapy.
* Surgery under general anesthesia; immunotherapy; radiotherapy; or initiation of hormonal therapy within the three weeks prior to enrollment.
* Acupuncture in the previous six weeks.
* Change in use of any of the following drugs in the prior three weeks: opiates, antidepressants (other than selective serotonin reuptake inhibitors \[SSRIs\])/anxiolytics; OR change in use of SSRIs in the prior six weeks. "Change in use" is defined as initiation or cessation of treatment, or change in prescribed dose or regimen: changes in actual amounts of PRN medication taken are allowed.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT00658034
Study Brief:
Protocol Section:
NCT00658034