Clinical trial · Interventional
Corticosteroids for Cancer Pain
NCT00676936CI-TRIAL-00046883completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methylprednisolone | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Methylprednisolone
- description
- Methylprednisolone 16 mg twice daily
- interventionNames
- Drug: Methylprednisolone
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo capsules twice daily
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- pain intensity at Day 7
- timeFrame
- 7 days
- description
- change of pain intensity at Day 7, measured by "average pain for the last 24 hours" (NRS 0-10).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (2)
- RESULTPaulsen 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 25002731
- RESULTJakobsen 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 32856209