Study hypothesis: corticosteroids are effective for pain in cancer patients. We will perform a double-blind, randomized, placebo-controlled multicentre trial evaluating the effect of Methylprednisolone 16 mg twice daily in cancer patients with pain (average pain last 24 hrs NRS \> 4 (Numerical rating scale, 0 No pain, 10 worst 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
50
Custom made capsules, Methylprednisolone 16 mg twice daily, intervention period 7 days.
Custom made capsules, Lactose, administered twice daily, intervention period 7 days
Haraldsplass Diakonale sykehus
Bergen, Norway
Sykehuset Buskerud HF
Drammen, Norway
Sørlandet Sykehus HF
Kristiansand, Norway
Oslo Universitetssykehus, Ulleval
Oslo, Norway
pain intensity at Day 7
change of pain intensity at Day 7, measured by "average pain for the last 24 hours" (NRS 0-10).
Time frame: 7 days
fatigue
change of fatigue measured by EORTC QLQ30 and ESAS
Time frame: 7 days
appetite
change of appetite measured by EORTC QLQ30 and ESAS
Time frame: 7 days
Overall effect satisfaction
Overall effect measured by a global satisfaction-question ("How is your overall benefit from the medication?" NRS: 0= No important benefit 10=very important benefit).
Time frame: 7 days
sleep quality
change of sleep quality measured by Pittsburgh Sleep Quality Index
Time frame: 7 days
analgesic usage
change of analgesic usage measured by morphine equivalents.
Time frame: 7 days
Pain now and average pain last 24 hrs
Pain now and average pain last 24 hours measured by daily NRS (Numeric rating scale)(ESAS)
Time frame: 7 days
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Sykehuset Telemark HF
Skien, Norway
St Olavs Hospital HF
Trondheim, Norway