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
18 Years
N/A
Both
B-cell Lymphoma, Fatigue
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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).
Outcome Time Frame:
13 weeks
Safety Issue:
No
Principal Investigator
Nina Wagner-Johnston, M
Investigator Role:
Principal Investigator
Investigator Affiliation:
Washington University School of Medicine
Authority:
United States: Institutional Review Board
Study ID:
09-1896
NCT ID:
NCT01044004
Start Date:
March 2010
Completion Date:
June 2012
Related Keywords:
- B-Cell Lymphoma
- Fatigue
- Fatigue
- Lymphoma
- Lymphoma, B-Cell
Name | Location |
|---|
