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

22 juli 2013 uppdaterad av: Washington University School of Medicine

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.

Studieöversikt

Status

Indragen

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Fas

  • Inte tillämpbar

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Post treatment remission armodafinil
Armodafinil 150 mg/day for 13 weeks
Läkemedel: Armodafinil
Armodafinil 150 mg/day for 13 weeks
Andra namn:
  • Nuvigil
Placebo-jämförare: Post treatment remission placebo
Placebo 150mg/day for 13 weeks
Läkemedel: placebo
Placebo 150mg/day for 13 weeks
Experimentell: Chemotherapy armodafinil
Armodafinil 150 mg/day for 13 weeks
Läkemedel: Armodafinil
Armodafinil 150 mg/day for 13 weeks
Andra namn:
  • Nuvigil
Placebo-jämförare: Chemotherapy placebo
Placebo 150mg/day for 13 weeks
Läkemedel: placebo
Placebo 150mg/day for 13 weeks

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
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).
Tidsram: 13 weeks
13 weeks

Sekundära resultatmått

Resultatmått
Tidsram
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).
Tidsram: 13 weeks
13 weeks
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).
Tidsram: 13 weeks
13 weeks
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).
Tidsram: 13 weeks
13 weeks
To evaluate whether measured cytokines (IL-2, IL-6, IL-10, TNF-α, and TGF-α) are elevated at baseline.
Tidsram: 13 weeks
13 weeks
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.
Tidsram: 13 weeks
13 weeks
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.
Tidsram: 13 weeks
13 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Washington University School of Medicine

Utredare

  • Huvudutredare: Nina Wagner-Johnston, M, Washington University School of Medicine

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2010

Primärt slutförande (Förväntat)

1 juni 2012

Avslutad studie (Förväntat)

1 juni 2012

Studieregistreringsdatum

Först inskickad

6 januari 2010

Först inskickad som uppfyllde QC-kriterierna

6 januari 2010

Första postat (Uppskatta)

7 januari 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

23 juli 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 juli 2013

Senast verifierad

1 juli 2013

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 09-1896

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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