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- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Post treatment remission armodafinil
Armodafinil 150 mg/day for 13 weeks
|
Armodafinil 150 mg/day for 13 weeks
Andere namen:
|
Placebo-vergelijker: Post treatment remission placebo
Placebo 150mg/day for 13 weeks
|
Placebo 150mg/day for 13 weeks
|
Experimenteel: Chemotherapy armodafinil
Armodafinil 150 mg/day for 13 weeks
|
Armodafinil 150 mg/day for 13 weeks
Andere namen:
|
Placebo-vergelijker: Chemotherapy placebo
Placebo 150mg/day for 13 weeks
|
Placebo 150mg/day for 13 weeks
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
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).
Tijdsspanne: 13 weeks
|
13 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
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).
Tijdsspanne: 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).
Tijdsspanne: 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).
Tijdsspanne: 13 weeks
|
13 weeks
|
To evaluate whether measured cytokines (IL-2, IL-6, IL-10, TNF-α, and TGF-α) are elevated at baseline.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 13 weeks
|
13 weeks
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Nina Wagner-Johnston, M, Washington University School of Medicine
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Neoplasmata
- Lymfoproliferatieve aandoeningen
- Lymfatische ziekten
- Immunoproliferatieve aandoeningen
- Lymfoom, non-Hodgkin
- Lymfoom
- Lymfoom, B-cel
- Vermoeidheid
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Cytochroom P-450 enzyminductoren
- Cytochroom P-450 CYP3A-inductoren
- Stimulerende middelen voor het centrale zenuwstelsel
- Waakbevorderende middelen
- Modafinil
Andere studie-ID-nummers
- 09-1896
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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