Status:
COMPLETED
Corticosteroids for Cancer Pain
Lead Sponsor:
Norwegian University of Science and Technology
Conditions:
Cancer
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 Methylprednisolon...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Verified malignant disease
- Receiving a scheduled strong or weak opioid
- Insufficient pain control: Average pain last 24 h: ≥ 4 (NRS 0-10)
- Given informed consent according to the ethical guidelines
- Able to complete planned assessment schedules
- ≥ 18 years of age
- Life expectancy \> 1 month
Exclusion
- Excruciating pain (average pain ≥ 8) (These patients should be considered as emergency patients. Patients may be eligible for the study after stabilization)
- Dose adjustment in scheduled opioid medication last 48 hours
- Concurrent medication with NSAIDs (Patients are eligible for the study one week after NSAIDs are discontinued)
- Receiving radiotherapy within 4 weeks before entering the study or planned within the study period
- Started systemic treatment (chemotherapy, hormone therapy or bisphosphonates) within 4 weeks before entering the study Patients who have received chemotherapy for more than 4 weeks are eligible for the study if it is more than 7 days since receiving the last dose and they are not having the next dose within the study period
- Manifest spinal cord compression or in need of bone surgery
- Severe cognitive impairment
- Previously on steroids during the last 4 weeks
- Diabetes mellitus
- Known peptic ulcer disease
- Systemic fungal disease, patients vaccinated with viable viruses, and patients with known allergies to the study medication (MethylPrednisolone)
- Female patients who are pregnant or lactating.
- Women of reproductive potential not willing or unable to employ an effective method of contraception (be sterilized, using IUD or oral contraception)
- Patients using following medication: cyclosporin, erythromycin, phenobarbital, phenytoin, carbamazepin, ketoconazole, methotrexate, ciclofosfamide, rifampicin, aprepitant and diltiazem.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00676936
Start Date
April 1 2008
End Date
February 1 2012
Last Update
September 1 2020
Active Locations (6)
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1
Haraldsplass Diakonale sykehus
Bergen, Norway, 5009
2
Sykehuset Buskerud HF
Drammen, Norway, 3004
3
Sørlandet Sykehus HF
Kristiansand, Norway, 4606
4
Oslo Universitetssykehus, Ulleval
Oslo, Norway, 0407