- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01044004
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Post treatment remission armodafinil
Armodafinil 150 mg/day for 13 weeks
|
Armodafinil 150 mg/day for 13 weeks
Otros nombres:
|
Comparador de placebos: Post treatment remission placebo
Placebo 150mg/day for 13 weeks
|
Placebo 150mg/day for 13 weeks
|
Experimental: Chemotherapy armodafinil
Armodafinil 150 mg/day for 13 weeks
|
Armodafinil 150 mg/day for 13 weeks
Otros nombres:
|
Comparador de placebos: Chemotherapy placebo
Placebo 150mg/day for 13 weeks
|
Placebo 150mg/day for 13 weeks
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
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).
Periodo de tiempo: 13 weeks
|
13 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 13 weeks
|
13 weeks
|
To evaluate whether measured cytokines (IL-2, IL-6, IL-10, TNF-α, and TGF-α) are elevated at baseline.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 13 weeks
|
13 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nina Wagner-Johnston, M, Washington University School of Medicine
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Enfermedades linfáticas
- Trastornos inmunoproliferativos
- Linfoma No Hodgkin
- Linfoma
- Linfoma de células B
- Fatiga
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inductores de enzimas de citocromo P-450
- Inductores de citocromo P-450 CYP3A
- Estimulantes del Sistema Nervioso Central
- Agentes promotores de la vigilia
- Modafinilo
Otros números de identificación del estudio
- 09-1896
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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