Corticosteroids for Cancer Pain

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Norwegian University of Science and Technology
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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.