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
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
To determine whether armodafinil is more effective than placebo in reducing fatigue.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2010
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2010
CompletedFirst Posted
Study publicly available on registry
January 7, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJuly 23, 2013
July 1, 2013
2.3 years
January 6, 2010
July 22, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
To determine whether armodafinil is more effective than placebo in reducing fatigue as measured by the change in scores from the FACT-Fatigue reported at study entry, week 7 of study treatment, and study completion (week 13).
13 weeks
Secondary Outcomes (6)
To determine whether armodafinil is more effective than placebo in improving work quality as measured by the change in scores from the WLQ© reported at study entry (week 1) and study completion (week 13).
13 weeks
To determine whether armodafinil is more effective than placebo in reducing fatigue as measured by standard actigraphy summary statistics will be done at week 1 of screening, week 7 of study treatment, and study completion (week 13).
13 weeks
To determine whether armodafinil is more effective than placebo in reducing fatigue as measured by actigraphy using applied functional data analysis during week 1 of screening, week 7 of study treatment, and study completion (week 13).
13 weeks
To evaluate whether measured cytokines (IL-2, IL-6, IL-10, TNF-α, and TGF-α) are elevated at baseline.
13 weeks
To evaluate whether measured cytokines (IL-2, IL-6, IL-10, TNF-α, and TGF-α) change from the time of study entry to study completion.
13 weeks
- +1 more secondary outcomes
Study Arms (4)
Post treatment remission armodafinil
EXPERIMENTALArmodafinil 150 mg/day for 13 weeks
Post treatment remission placebo
PLACEBO COMPARATORPlacebo 150mg/day for 13 weeks
Chemotherapy armodafinil
EXPERIMENTALArmodafinil 150 mg/day for 13 weeks
Chemotherapy placebo
PLACEBO COMPARATORPlacebo 150mg/day for 13 weeks
Interventions
Armodafinil 150 mg/day for 13 weeks
Eligibility Criteria
You may qualify if:
- 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.
- Scheduled to receive 6 cycles of standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy as first-line treatment
- May have received one prior regimen of chemotherapy and/or radiotherapy
- Adequate response to upfront chemotherapy and/or radiotherapy
- +5 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nina Wagner-Johnston, M
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2010
First Posted
January 7, 2010
Study Start
March 1, 2010
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
July 23, 2013
Record last verified: 2013-07