Corticosteroids for Cancer Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Corticosteroids for Cancer Pain

Conditions
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Cancer, Pain

Intervention / Treatment
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* Drug: Methylprednisolone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylprednisolone<br>Methylprednisolone 16 mg twice daily | Drug: Methylprednisolone<br>* Custom made capsules, Methylprednisolone 16 mg twice daily, intervention period 7 days.<br>* Other names: Medrol (TM);|
| Placebo Comparator: Placebo<br>Placebo capsules twice daily | Drug: Placebo<br>* Custom made capsules, Lactose, administered twice daily, intervention period 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity at Day 7 | change of pain intensity at Day 7, measured by average pain for the last 24 hours (NRS 0-10). | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fatigue | change of fatigue measured by EORTC QLQ30 and ESAS | 7 days | 
| appetite | change of appetite measured by EORTC QLQ30 and ESAS | 7 days | 
| Overall effect satisfaction | Overall effect measured by a global satisfaction-question (How is your overall benefit from the medication? NRS: 0= No important benefit 10=very important benefit). | 7 days | 
| sleep quality | change of sleep quality measured by Pittsburgh Sleep Quality Index | 7 days | 
| analgesic usage | change of analgesic usage measured by morphine equivalents. | 7 days | 
| Pain now and average pain last 24 hrs | Pain now and average pain last 24 hours measured by daily NRS (Numeric rating scale)(ESAS) | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, pain, corticosteroids, palliative, supportive care, Cancer patients with pain