Clinical trial · Interventional
Evaluate the Efficacy of Armodafinil for Patients With B-cell Lymphoma and Severe Fatigue
A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Efficacy of Armodafinil for Patients With B-cell Lymphoma and Severe Fatigue Undergoing Standard R-CHOP Chemotherapy or in Remission Following Chemo and/or Radiation
NCT01044004CI-TRIAL-00011451withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine whether armodafinil is more effective than placebo in reducing fatigue.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Armodafinil | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Post treatment remission armodafinil
- description
- Armodafinil 150 mg/day for 13 weeks
- interventionNames
- Drug: Armodafinil
- type
- PLACEBO_COMPARATOR
- label
- Post treatment remission placebo
- description
- Placebo 150mg/day for 13 weeks
- interventionNames
- Drug: placebo
- type
- EXPERIMENTAL
- label
- Chemotherapy armodafinil
- description
- Armodafinil 150 mg/day for 13 weeks
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.