Corticosteroids for Cancer Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00676936|
Recruitment Status : Completed
First Posted : May 13, 2008
Last Update Posted : July 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cancer Pain||Drug: Methylprednisolone Drug: Placebo||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Corticosteroids for Cancer Pain|
|Study Start Date :||April 2008|
|Primary Completion Date :||February 2012|
|Study Completion Date :||February 2012|
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
- pain intensity at Day 7 [ Time Frame: 7 days ]change of pain intensity at Day 7, measured by "average pain for the last 24 hours" (NRS 0-10).
- fatigue [ Time Frame: 7 days ]change of fatigue measured by EORTC QLQ30 and ESAS
- appetite [ Time Frame: 7 days ]change of appetite measured by EORTC QLQ30 and ESAS
- Overall effect satisfaction [ Time Frame: 7 days ]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 ]change of sleep quality measured by Pittsburgh Sleep Quality Index
- analgesic usage [ Time Frame: 7 days ]change of analgesic usage measured by morphine equivalents.
- Pain now and average pain last 24 hrs [ Time Frame: 7 days ]Pain now and average pain last 24 hours measured by daily NRS (Numeric rating scale)(ESAS)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|