Corticosteroids for Cancer Pain
Study hypothesis: Has corticosteroids an effect on pain in cancer patients? We are performing 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).
Description
Patients are required to use strong opioids before entering the study. Weak opioids are allowed if patients have shortacting 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 shortacting 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.
Status: Recruiting (Phase 3). Started on April 1st, 2008.
Enrollment: 55 subjects
Study Type: Interventional
Study Design:
- Allocation: Randomized
- Endpoint Classification: Efficacy Study
- Intervention Model: Parallel Assignment
- Masking: Double Blind (Subject
- Caregiver
- Investigator
- Outcomes Assessor)
- Primary Purpose: Supportive Care
Conditions:
Interventions:
- Drug: Methylprednisolone (Medrol (TM))
- Drug: Placebo
Eligibility
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, methotrexat, ciclofosfamid, rifampicin, aprepitant and diltiazem.
- Gender
Both
- Mininum Age
18 Years
- Maximum Age
N/A
- Healthy Volunteers
No
Resources
Source: Norwegian University of Science and Technology
Authority: Norway: The National Committees for Research Ethics in Norway
Locations
-
Haraldsplass Diakonale sykehus
Bergen
5009
Norway
-
Sykehuset Buskerud HF
Drammen
3004
Norway
-
S��rlandet Sykehus HF
Kristiansand
4606
Norway
-
Oslo Universitetssykehus, Ulleval
Oslo
0407
Norway
-
Sykehuset Telemark HF
Skien
3712
Norway
-
St Olavs Hospital HF
Trondheim
7006
Norway
Officials
None.
Sponsors
Norwegian University of Science and Technology (Lead Sponsor)
References
None.
Links
None.
- Date Verified
- August 1st, 2010
- First Received
- August 23rd, 2010
- Last Changed
- August 23rd, 2010
Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.
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