WithdrawnNCT01044004Updated Jul 23, 2013

Evaluate the Efficacy of Armodafinil for Patients With B-cell Lymphoma and Severe Fatigue

An interventional study of Armodafinil and placebo in B-cell Lymphoma and Fatigue, sponsored by Washington University School of Medicine. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-23.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 0
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

To determine whether armodafinil is more effective than placebo in reducing fatigue.

Read the detailed description

Aims will be analyzed separately as stratified by treatment arm (chemotherapy treatment arm vs. post-treatment remission arm).

Primary Objective:

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).

Secondary Objectives:

To determine whether armodafinil is more effective than placebo in reducing fatigue as measured by standard actigraphy summary statistics including total sleep time (TST), wake after sleep onset (WASO), sleep latency, number of awakenings, daytime sleep time, mean daytime activity, peak activity, acrophase, and circadian mesor at week 1 of screening, week 7 of study treatment, and study completion (week 13).
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).
To determine whether armodafinil is more effective than placebo in reducing fatigue as measured by the change in activity patterns with actigraphy using applied functional data analysis during week 1 of screening, week 7 of study treatment, and study completion (week 13).
To evaluate whether measured cytokines (IL-2, IL-6, IL-10, TNF-α, and TGF-α) are elevated at baseline.
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.
To assess whether cytokine levels (IL-2, IL-6, IL-10, TNF-α, and TGF-α) correlate with circadian patterns in wrist actigraphy and self-described reports of fatigue as measured by the FACT-Fatigue at baseline and study completion.

Conditions studied

B-cell Lymphoma
Fatigue

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In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

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Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single group
Masking: Double (Participant, Investigator)
Enrollment: 0 participants (actual)

Study arms

Experimental
Post treatment remission armodafinil
Armodafinil 150 mg/day for 13 weeks
Drug: Armodafinil
Placebo comparator
Post treatment remission placebo
Placebo 150mg/day for 13 weeks
Drug: placebo
Experimental
Chemotherapy armodafinil
Armodafinil 150 mg/day for 13 weeks
Drug: Armodafinil
Placebo comparator
Chemotherapy placebo
Placebo 150mg/day for 13 weeks
Drug: placebo

Interventions

DrugArmodafinil
Armodafinil 150 mg/day for 13 weeks
Also known as: Nuvigil
Drugplacebo
Placebo 150mg/day for 13 weeks
DrugArmodafinil
Armodafinil 150 mg/day for 13 weeks
Also known as: Nuvigil
Drugplacebo
Placebo 150mg/day for 13 weeks

What researchers measure

Primary outcomes

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).
Time frame: 13 weeks

Secondary outcomes

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).
Time frame: 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).
Time frame: 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).
Time frame: 13 weeks
To evaluate whether measured cytokines (IL-2, IL-6, IL-10, TNF-α, and TGF-α) are elevated at baseline.
Time frame: 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.
Time frame: 13 weeks
To assess whether cytokine levels (IL-2, IL-6, IL-10, TNF-α, and TGF-α) correlate with circadian patterns in wrist actigraphy and self-described reports of fatigue as measured by the FACT-Fatigue at baseline and study completion.
Time frame: 13 weeks

Study locations

No study locations are listed for this record.

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01044004
Lead sponsor: Washington University School of Medicine
Responsible party: Sponsor
First posted: Jan 7, 2010
Start date: Mar 2010
Primary completion: Jun 2012 (estimated)
Completion: Jun 2012 (estimated)
Last update: Jul 23, 2013

Study contacts

Nina Wagner-Johnston, M

principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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