NCT00676936

Corticosteroids for Cancer Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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 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.

Conditions

• Cancer
• Pain

Interventions

Type	Name	Description
DRUG	Methylprednisolone	Custom made capsules, Methylprednisolone 16 mg twice daily, intervention period 7 days.
DRUG	Placebo	Custom made capsules, Lactose, administered twice daily, intervention period 7 days

Timeline

• Start date: 2008-04-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2008-05-13
• Last updated: 2020-09-01

Locations

6 sites across 1 country: Norway