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 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT01044004
Eligibility Criteria:
Inclusion Criteria for both arms:
* Age ≥ 18 with diagnosis of B-cell lymphoma
* Average score of ≥ 7 on daily worst fatigue severity assessment from the BFI questionnaire during screening
* Able to demonstrate appropriate use of the wrist actigraphy device and to complete questionnaires
* ECOG performance status 0-2
* Laboratory values:
* Hemoglobin ≥ 10 g/dL
* Total Bilirubin ≤ 1.5 x institutional ULN
* AST/ALT ≤ 2.5 x institutional ULN
* Creatinine ≤ 1.5 x institutional ULN
* Albumin ≥ 3.5 g/dl
* Life expectancy \> 6 months
* IRB-approved informed consent form must be signed before any protocol-specific screening procedures are performed.
Inclusion criteria for patients undergoing R-CHOP chemotherapy:
* Scheduled to receive 6 cycles of standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy as first-line treatment
Inclusion criteria for patients in remission following chemotherapy and/or radiotherapy:
* May have received one prior regimen of chemotherapy and/or radiotherapy
* Adequate response to upfront chemotherapy and/or radiotherapy
* Indolent lymphomas - must have achieved a partial or complete response with no immediate plans for further treatment
* Aggressive lymphomas - must have achieved a complete response:
* ≥ 4 weeks since completion of chemotherapy
* ≥ 8 weeks since completion of radiotherapy
* ≤ 18 months since completion of chemotherapy or radiotherapy
Exclusion Criteria for both arms:
* Uncontrolled medical and/or psychiatric condition that may cause fatigue or that the PI feels is clinically significant and might adversely affect patient safety (such as sleep disorders, moderate/severe depression, metabolic/endocrine abnormalities, infections)
* History of clinically significant cardiac disorders, such as left ventricular hypertrophy or mitral valve prolapse experienced in conjunction with receiving CNS stimulants
* History of serious skin reactions, such as serious rash or Stevens-Johnson Syndrome
* Concurrent stimulant medication
* Any other active malignancy within the past 3 years except cervical carcinoma in situ and non-melanoma skin cancers
* Known CNS involvement by lymphoma
* Cachexia
* Use of opioids at time of randomization
* Known sensitivity to modafinil and/or armodafinil
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01044004
Study Brief:
Protocol Section:
NCT01044004