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Modafinil in Treating Fatigue in Patients With Cancer

19 agosto 2009 aggiornato da: University of Virginia

Pilot Study Evaluating the Safety and Efficacy of Modafinil in Improving Fatigue, Mood, Cognitive Ability, Functional Status, and Quality of Life of Cancer Patients

RATIONALE: Modafinil may help relieve fatigue and improve quality of life in patients with cancer.

PURPOSE: This clinical trial is studying how well modafinil works in treating fatigue in patients with cancer.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

OBJECTIVES:

Primary

Determine the safety of modafinil in cancer patients.
Determine the efficacy of this drug, in terms of improving fatigue, in these patients.

Secondary

Determine the efficacy of this drug, in terms of improving mood, cognitive ability, functional status, and quality of life, in these patients.

OUTLINE: This is a nonrandomized, pilot study.

Patients receive oral modafinil once daily for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive additional modafinil at the discretion of the physician.

Fatigue, mood, cognition, functional status, and quality of life are assessed at baseline and in weeks 2 and 4.

After completion of study treatment, patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study within 9 months.

Tipo di studio

Interventistico

Fase

Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Stati Uniti
- Virginia
  - Charlottesville, Virginia, Stati Uniti, 22908
    - University of Virginia Cancer Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

DISEASE CHARACTERISTICS:

Diagnosis of cancer
Brief Fatigue Inventory score ≥ 4

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 1-3

Life expectancy

At least 2 months

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Cardiovascular

No history of left ventricular hypertrophy
No history of ischemic ECG changes
No history of chest pain
No history of arrhythmia
No history of other clinically significant manifestations of mitral valve prolapse in association with CNS stimulant use

Other

Not pregnant or nursing
Negative pregnancy test
Thyroid stimulating hormone normal
No known hypersensitivity to modafinil
No history of psychotic disorder and/or active psychosis
No history of any chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation or compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

Concurrent thalidomide allowed

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Other

Concurrent narcotics, phenothiazines, or benzodiazepines allowed
No other concurrent investigational therapy

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Terapia di supporto

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Safety, in terms of adverse events and dose-limiting toxicity, as measured by NCI CTC v2.0 at up to 4 weeks after the start of treatment
Fatigue as measured by Brief Fatigue Inventory at 2 and 4 weeks after the start of treatment

Misure di risultato secondarie

Misura del risultato
Mood as measured by Hamilton Rating Scale for Depression at 2 and 4 weeks after the start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Hopkins Verbal Learning Test at 2 and 4 weeks after start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Grooved Pegboard Test at 2 and 4 weeks after start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Controlled Oral Word Association Test from the Multilingual Aphasia Examination at 2 and 4 weeks after start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Trail Making Test A and B at 2 and 4 weeks after start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Recall and Recognition of Word List encoded from the Hopkins Verbal Learning Test at 2 and 4 weeks after start of treatment
Functional status as measured by Barthel Index and ECOG performance status at 2 and 4 weeks after the start of treatment
Quality of life as measured by Functional Assessment of Cancer Therapy-Br at 2 and 4 weeks after the start of treatment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Virginia

Collaboratori

National Cancer Institute (NCI)

Investigatori

Investigatore principale: Leslie Blackhall, MD, University of Virginia

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2004

Date di iscrizione allo studio

Primo inviato

2 giugno 2005

Primo inviato che soddisfa i criteri di controllo qualità