Trial Information

Modafinil to Reduce Persistent Fatigue in Patients Following Treatment for Cancer

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:

1. better control of the fatigue reported by patients during and following cancer
treatment is needed,

2. there are few systematic data on the etiology of fatigue following cancer treatment,
and

3. 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.