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Corticosteroids for Cancer Pain

Phase 3
18 Years
Not Enrolling
Cancer, Pain

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Trial Information

Corticosteroids for Cancer Pain

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

pain intensity at Day 7

Outcome Description:

change of pain intensity at Day 7, measured by "average pain for the last 24 hours" (NRS 0-10).

Outcome Time Frame:

7 days

Safety Issue:


Principal Investigator

Stein Kaasa, MD PhD prof

Investigator Role:

Study Director

Investigator Affiliation:

Norwegian University of Science and Technology


Norway: Norwegian Medicines Agency

Study ID:

OPI 07-005



Start Date:

April 2008

Completion Date:

February 2012

Related Keywords:

  • Cancer
  • Pain
  • Cancer
  • pain
  • corticosteroids
  • palliative
  • supportive care
  • Cancer patients with pain