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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676936
|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|