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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01044004
First received: January 6, 2010
Last updated: July 22, 2013
Last verified: July 2013

January 6, 2010
July 22, 2013
March 2010
June 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01044004 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate whether measured cytokines (IL-2, IL-6, IL-10, TNF-α, and TGF-α) are elevated at baseline. [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • B-cell Lymphoma
  • Fatigue
  • Drug: Armodafinil
    Armodafinil 150 mg/day for 13 weeks
    Other Name: Nuvigil
  • Drug: placebo
    Placebo 150mg/day for 13 weeks
  • Experimental: Post treatment remission armodafinil
    Armodafinil 150 mg/day for 13 weeks
    Intervention: Drug: Armodafinil
  • Placebo Comparator: Post treatment remission placebo
    Placebo 150mg/day for 13 weeks
    Intervention: Drug: placebo
  • Experimental: Chemotherapy armodafinil
    Armodafinil 150 mg/day for 13 weeks
    Intervention: Drug: Armodafinil
  • Placebo Comparator: Chemotherapy placebo
    Placebo 150mg/day for 13 weeks
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01044004
09-1896
Yes
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Nina Wagner-Johnston, M Washington University School of Medicine
Washington University School of Medicine
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP