Corticosteroids for Cancer Pain
2 other identifiers
interventional
50
1 country
6
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 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 cancer
Started Apr 2008
Typical duration for phase_3 cancer
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 8, 2008
CompletedFirst Posted
Study publicly available on registry
May 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedSeptember 1, 2020
August 1, 2020
3.8 years
May 8, 2008
August 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pain intensity at Day 7
change of pain intensity at Day 7, measured by "average pain for the last 24 hours" (NRS 0-10).
7 days
Secondary Outcomes (6)
fatigue
7 days
appetite
7 days
Overall effect satisfaction
7 days
sleep quality
7 days
analgesic usage
7 days
- +1 more secondary outcomes
Study Arms (2)
Methylprednisolone
EXPERIMENTALMethylprednisolone 16 mg twice daily
Placebo
PLACEBO COMPARATORPlacebo capsules twice daily
Interventions
Custom made capsules, Methylprednisolone 16 mg twice daily, intervention period 7 days.
Custom made capsules, Lactose, administered twice daily, intervention period 7 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Haraldsplass Diakonale sykehus
Bergen, 5009, Norway
Sykehuset Buskerud HF
Drammen, 3004, Norway
Sørlandet Sykehus HF
Kristiansand, 4606, Norway
Oslo Universitetssykehus, Ulleval
Oslo, 0407, Norway
Sykehuset Telemark HF
Skien, 3712, Norway
St Olavs Hospital HF
Trondheim, 7006, Norway
Related Publications (2)
Paulsen O, Klepstad P, Rosland JH, Aass N, Albert E, Fayers P, Kaasa S. Efficacy of methylprednisolone on pain, fatigue, and appetite loss in patients with advanced cancer using opioids: a randomized, placebo-controlled, double-blind trial. J Clin Oncol. 2014 Oct 10;32(29):3221-8. doi: 10.1200/JCO.2013.54.3926. Epub 2014 Jul 7.
PMID: 25002731RESULTJakobsen G, Engstrom M, Hjermstad MJ, Rosland JH, Aass N, Albert E, Kaasa S, Fayers P, Klepstad P, Paulsen O. The short-term impact of methylprednisolone on patient-reported sleep in patients with advanced cancer in a randomized, placebo-controlled, double-blind trial. Support Care Cancer. 2021 Apr;29(4):2047-2055. doi: 10.1007/s00520-020-05693-6. Epub 2020 Aug 27.
PMID: 32856209RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Stein Kaasa, MD PhD prof
Norwegian University of Science and Technology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2008
First Posted
May 13, 2008
Study Start
April 1, 2008
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
September 1, 2020
Record last verified: 2020-08