Preventing Fatigue in Women With Breast Cancer Treated With Chemotherapy

摘要

This is the third annual report on a randomized, double-blind, placebo-controlled clinical trial of 130 consecutive breast cancer patients who are being studied over four successive chemotherapy treatments to assess if an antidepressant drug can attenuate or prevent the development of fatigue in women during chemotherapy treatment. We are also examining the potential role of depression, sleep disturbance and the cytokine TNF-alpha in the development of fatigue during chemotherapy treatment. Patients are randomized to take the antidepressant paroxetine Paxil(registered) or placebo once a day during the trial. They complete standardized psychometric measures of fatigue and depression on the 7th day following each of the four chemotherapy cycles. Patient motion is assessed as a concomitant measure of fatigue by ambulatory electronic monitoring during the second and fourth assessments. Blood levels of TNF-alpha are also measured at these two treatments. Patient accrual began at the first site in November, 1996. In order to maximize our accrual, we opened the study at a second site (Highland Hospital) in October 1997 and began accrual at a third site (Strong Memorial Hospital) in July 1998. We anticipate no problem in meeting our target of 100 evaluable patients.