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This study has been withdrawn prior to enrollment.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
  Purpose

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


Condition Intervention
B-cell Lymphoma
Fatigue
Drug: Armodafinil
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: March 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Post treatment remission armodafinil
Armodafinil 150 mg/day for 13 weeks
Drug: Armodafinil
Armodafinil 150 mg/day for 13 weeks
Other Name: Nuvigil
Placebo Comparator: Post treatment remission placebo
Placebo 150mg/day for 13 weeks
Drug: placebo
Placebo 150mg/day for 13 weeks
Experimental: Chemotherapy armodafinil
Armodafinil 150 mg/day for 13 weeks
Drug: Armodafinil
Armodafinil 150 mg/day for 13 weeks
Other Name: Nuvigil
Placebo Comparator: Chemotherapy placebo
Placebo 150mg/day for 13 weeks
Drug: placebo
Placebo 150mg/day for 13 weeks

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01044004

Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Nina Wagner-Johnston, M Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01044004     History of Changes
Other Study ID Numbers: 09-1896
Study First Received: January 6, 2010
Last Updated: July 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphoma, B-Cell
Fatigue
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Signs and Symptoms
Armodafinil
Modafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014