Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT01044004
Status:
WITHDRAWN
Last Update Posted:
2013-07-23
First Post:
2010-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy of Armodafinil for Patients With B-cell Lymphoma and Severe Fatigue
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
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
Status:
WITHDRAWN
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: