Corticosteroids for Cancer Pain

Norwegian University of Science and Technology

Status and phase

Completed

Phase 3

Conditions

Cancer

Pain

Treatments

Drug: Methylprednisolone

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00676936

OPI 07-005

2007-005617-19 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.