The primary objective of this protocol is to evaluate the ability of the drug armodafinil to lessen the fatigue experienced by this group of patients.
"Fatigue related symptoms can include drowsiness, sleepiness, difficulty with sleep and feeling tired," says G. Brandon Gunn, M.D., assistant professor in the Department of Radiation Oncology and principal investigator on the trial, "By using armodafinil, we're trying to stimulate the central nervous system to overcome these patient-reported symptoms."
Gunn says fatigue is the number one symptom that head and neck cancer patients report after radiation treatment.
What you need to know "Patients should know they are not alone in experiencing it, but medical causes for fatigue should be ruled out first," Gunn says. "They should also know that armodafinil is approved by the U.S. Food and Drug Administration and is being studied for fatigue."
The secondary objective of the trial is to explore the effects of armodafinil in reducing the severity of other symptoms and symptom interference with daily living, including alertness, work productivity and normal activities.
Reduction of fatigue symptoms is the goal
Charles Cleeland, Ph.D., professor and chair of the Department of Symptom Research, says fatigue symptoms can intrude on patients' ability to work and their personal lives.
"These side effects often make treatment intolerable, which makes the patient reduce or terminate the therapy," Cleeland says. "Our department's approach is to try to understand the biological reasons these symptoms occur."
Cleeland says he is looking for several outcomes from the trial.
"Can we understand some of the biological reasons people get tired after radiation therapy? Can we come up with agents that prevent or reduce symptom burden related to treatment?"
The National Cancer Institute, through a program project grant and an investigator-initiated grant, funds the trial.
Fatigue inventory tool
Participants will be assessed using the Brief Fatigue Inventory tool, developed by Cleeland, to rapidly determine the severity and impact of cancer-related fatigue.
Enrolled participants are expected to take their medication every day and complete symptom questionnaires weekly for six weeks.
To accommodate a participants' schedule, questionnaires can be completed over the phone with study staff, using the automated interactive voice response system, or by mail.
For more information about the clinical trial, contact G. Brandon Gunn, M.D., at 713-563-2300, or Araceli Garcia-Gonzalez, M.D., senior coordinator of clinical studies at 713-792-0278.