Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Eastern Cooperative Oncology Group
With
OBJECTIVES: * Compare the effect of epoetin alfa with or without dexamethasone on the level of cancer-related fatigue measured by the FACIT fatigue subscale, in patients with hormone-refractory prostate cancer. * Compare the effect of these regimens on increasing hemoglobin levels in these patients. * Compare the effect of these regimens on palliation of other disease-related symptoms and on functional status and overall quality of life of these patients. * Compare the survival rate of these regimens in these patients. * Compare the toxicity profile of these regimens in these patients. * Determine the incidence of adrenal suppression in these patients after receiving dexamethasone therapy. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to usual fatigue severity on the Brief Fatigue Inventory numerical scale (3-6 vs 7-10) and hemoglobin level (8-10 g/dL vs 10.1-11.9 g/dL). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive epoetin alfa subcutaneously once a week. * Arm II: Patients receive epoetin alfa as in arm I and oral dexamethasone once a day. In both arms, treatment continues for 12 weeks in the absence of unacceptable toxicity. Quality of life and fatigue are assessed at baseline and then at 4, 8, and 12 weeks. Patients are followed for 3 years. PROJECTED ACCRUAL: A total of 282 patients (141 per treatment arm) will be accrued for this study within approximately 3 years.
Age
18–120
Sex
MALE
Healthy volunteers
Not accepted
