Corticosteroids for Cancer Pain
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Corticosteroids for Cancer Pain|
- pain intensity at Day 7 [ Time Frame: 7 days ] [ Designated as safety issue: No ]change of pain intensity at Day 7, measured by "average pain for the last 24 hours" (NRS 0-10).
- fatigue [ Time Frame: 7 days ] [ Designated as safety issue: No ]change of fatigue measured by EORTC QLQ30 and ESAS
- appetite [ Time Frame: 7 days ] [ Designated as safety issue: No ]change of appetite measured by EORTC QLQ30 and ESAS
- Overall effect satisfaction [ Time Frame: 7 days ] [ Designated as safety issue: No ]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).
- sleep quality [ Time Frame: 7 days ] [ Designated as safety issue: No ]change of sleep quality measured by Pittsburgh Sleep Quality Index
- analgesic usage [ Time Frame: 7 days ] [ Designated as safety issue: No ]change of analgesic usage measured by morphine equivalents.
- Pain now and average pain last 24 hrs [ Time Frame: 7 days ] [ Designated as safety issue: No ]Pain now and average pain last 24 hours measured by daily NRS (Numeric rating scale)(ESAS)
|Study Start Date:||April 2008|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Methylprednisolone 16 mg twice daily
Custom made capsules, Methylprednisolone 16 mg twice daily, intervention period 7 days.
Other Name: Medrol (TM)
Placebo Comparator: Placebo
Placebo capsules twice daily
Custom made capsules, Lactose, administered twice daily, intervention period 7 days
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.
|Haraldsplass Diakonale sykehus|
|Bergen, Norway, 5009|
|Sykehuset Buskerud HF|
|Drammen, Norway, 3004|
|Sørlandet Sykehus HF|
|Kristiansand, Norway, 4606|
|Oslo Universitetssykehus, Ulleval|
|Oslo, Norway, 0407|
|Sykehuset Telemark HF|
|Skien, Norway, 3712|
|St Olavs Hospital HF|
|Trondheim, Norway, 7006|
|Study Director:||Stein Kaasa, MD PhD prof||Norwegian University of Science and Technology|