Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

22 juillet 2013 mis à jour par: 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.

Aperçu de l'étude

Statut

Retiré

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Phase

  • N'est pas applicable

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Post treatment remission armodafinil
Armodafinil 150 mg/day for 13 weeks
Médicament: Armodafinil
Armodafinil 150 mg/day for 13 weeks
Autres noms:
  • Nuvigile
Comparateur placebo: Post treatment remission placebo
Placebo 150mg/day for 13 weeks
Médicament: placebo
Placebo 150mg/day for 13 weeks
Expérimental: Chemotherapy armodafinil
Armodafinil 150 mg/day for 13 weeks
Médicament: Armodafinil
Armodafinil 150 mg/day for 13 weeks
Autres noms:
  • Nuvigile
Comparateur placebo: Chemotherapy placebo
Placebo 150mg/day for 13 weeks
Médicament: placebo
Placebo 150mg/day for 13 weeks

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
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).
Délai: 13 weeks
13 weeks

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Washington University School of Medicine

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 2010

Achèvement primaire (Anticipé)

1 juin 2012

Achèvement de l'étude (Anticipé)

1 juin 2012

Dates d'inscription aux études

Première soumission

6 janvier 2010

Première soumission répondant aux critères de contrôle qualité

6 janvier 2010

Première publication (Estimation)

7 janvier 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

23 juillet 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 juillet 2013

Dernière vérification

1 juillet 2013

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 09-1896

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Lymphome B

Essais cliniques sur Armodafinil

Rechercher des essais similaires

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

CROs by country

CROs in South Africa

Conditions

Maladies rares

Interventions en matière de drogue

Compléments alimentaires

Commanditaire / collaborateurs

Emplacements

3
S'abonner