Modafinil to Reduce Persistent Fatigue in Patients Following Treatment for Cancer
The purpose of this study is to determine the efficacy of modafinil with regard to reducing cancer-related fatigue in cancer patients following chemotherapy or radiation therapy. Secondarily, the effect of modafinil on cognitive dysfunction in the same population will be assessed.
The researchers hypothesize that administering modafinil (PROVIGIL®) to patients experiencing fatigue following completion of cancer treatment will lead to reduction in patient fatigue and prevention of or improvement in patient cognitive dysfunction.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Modafinil to Reduce Persistent Fatigue in Patients Following Treatment for Cancer|
- degree to which modafinil can reduce patient fatigue following treatment for cancer [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- cytokine blood levels [ Designated as safety issue: No ]
- depression measured by the Center for Epidemiologic Studies-Depression scale (CES-D) [ Designated as safety issue: No ]
- cognitive function measured by the Cognitive Drug Research (CDR) Cognitive Assessment [ Designated as safety issue: No ]
- psychological adjustment to cancer measured by the Mini-Mental Adjustment to Cancer scale (Mini-MAC) [ Designated as safety issue: No ]
|Study Start Date:||May 2004|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Modafinil 200 mg taken by mouth once a day. Subjects will take 2 100 mg tablets each morning.
Placebo Comparator: placebo
Inactive sugar pill, 2 are taken once a day in the morning
Fatigue is a very common and troublesome side effect experienced in cancer patients before, during and after chemotherapy and radiation treatment. This protocol will increase knowledge about the occurrence and treatment of fatigue that develops during cancer treatments with the rationale that:
- better control of the fatigue reported by patients during and following cancer treatment is needed,
- there are few systematic data on the etiology of fatigue following cancer treatment, and
- there is evidence indicating that chemotherapy is associated with cognitive dysfunction.
Comparisons: In this randomized, placebo-controlled study of cancer patients following their chemotherapy or radiation therapy, we will assess the efficacy of modafinil for relieving cancer-related fatigue by actigraphy and for preventing or improving cognitive dysfunction by computer-generated tasks that have previously been utilized to examine drug-induced changes in performance (CDR Cognitive Assessment). Additional outcome measures will include the Fatigue Symptom Checklist, POMS, Fatigue Severity Scale, sleepiness measured by the Epworth Sleepiness Scale, cytokine blood levels, depression measured by the CES-D, and psychological adjustment to cancer measured by the Mini-MAC.
The primary objective is to:
- compare changes in patient reported fatigue following completion of chemotherapy and/or radiation treatment for cancer in patients who receive open-label modafinil (PROVIGIL®) for 4 weeks
Secondary objectives are to:
- assess the persistence of any effect found with a randomized trial of responders to modafinil or placebo for 4 weeks (responders are those who report at least a 1 point decrease in fatigue as measured by the Brief Fatigue Inventory)
- assess the degree to which modafinil can prevent or reduce cognitive dysfunction following treatment for cancer
- investigate potential relationships among depression, fatigue, cytokines, and cognitive dysfunction
Anticipated results could provide potentially important new information with regard to clinical, theoretical, and methodologic applications; that is, improved pharmacologic and perhaps behavioral control of the debilitating fatigue commonly experienced by patients undergoing treatment for cancer.
|United States, New York|
|University of Rochester, James P. Wilmot Cancer Center|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Gary R. Morrow, Ph.D., M.S.||University of Rochester, James P. Wilmot Cancer Center, Radiation Oncology Department, Behavioral Medicine Unit, Box 704, 601 Elmwood Avenue, Rochester, NY 14642|