Corticosteroids for Cancer Pain
Patients are required to use strong opioids before entering the study. Weak opioids are
allowed if patients have short acting strong opioids as rescue-medication. The scheduled
opioids shall be stable last 48 hours before entering the study and will be kept stable
during the study period. Patients may use as much short acting rescue-medication as they
require. No other analgesic medication should be started during the study period.
The study is a multicentre trial. Patients will be randomized according to 1. study centre
(No 1-5) and 2. pain mechanism: skeletal metastases (yes/no).
Patients are evaluated Day 0 and Day 7 by palliative care physician. Patients will be
contacted by phone Day 1-6 and will fill in questionnaire regarding symptoms and analgesic
usage. Patients will be contacted Day 14 and 21 to fill in questionnaires regarding
symptoms, quality of life and side effects.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
pain intensity at Day 7
change of pain intensity at Day 7, measured by "average pain for the last 24 hours" (NRS 0-10).
Stein Kaasa, MD PhD prof
Norwegian University of Science and Technology
Norway: Norwegian Medicines Agency