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

NCT ID: NCT01044004

Last Updated: 2013-07-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-06-30

Brief Summary

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

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

B-cell Lymphoma; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Post treatment remission armodafinil

Armodafinil 150 mg/day for 13 weeks

Group Type: EXPERIMENTAL

Armodafinil

Intervention Type: DRUG

Armodafinil 150 mg/day for 13 weeks

Post treatment remission placebo

Placebo 150mg/day for 13 weeks

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Placebo 150mg/day for 13 weeks

Chemotherapy armodafinil

Armodafinil 150 mg/day for 13 weeks

Group Type: EXPERIMENTAL

Armodafinil

Intervention Type: DRUG

Armodafinil 150 mg/day for 13 weeks

Chemotherapy placebo

Placebo 150mg/day for 13 weeks

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Placebo 150mg/day for 13 weeks

Interventions

Armodafinil

Armodafinil 150 mg/day for 13 weeks

Intervention Type: DRUG

placebo

Placebo 150mg/day for 13 weeks

Intervention Type: DRUG

Armodafinil

Armodafinil 150 mg/day for 13 weeks

Intervention Type: DRUG

placebo

Placebo 150mg/day for 13 weeks

Intervention Type: DRUG

Other Intervention Names

Nuvigil; Nuvigil

Eligibility Criteria

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.

• 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
• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nina Wagner-Johnston, M

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

09-1896

Identifier Type: -

Identifier Source: org_study_id