Corticosteroids for Cancer Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00676936
Recruitment Status : Completed
First Posted : May 13, 2008
Last Update Posted : July 28, 2016
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief 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).

Condition or disease Intervention/treatment Phase
Cancer Pain Drug: Methylprednisolone Drug: Placebo Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Corticosteroids for Cancer Pain
Study Start Date : April 2008
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Arm Intervention/treatment
Experimental: Methylprednisolone
Methylprednisolone 16 mg twice daily
Drug: Methylprednisolone
Custom made capsules, Methylprednisolone 16 mg twice daily, intervention period 7 days.
Other Name: Medrol (TM)
Placebo Comparator: Placebo
Placebo capsules twice daily
Drug: Placebo
Custom made capsules, Lactose, administered twice daily, intervention period 7 days

Primary Outcome Measures :
  1. pain intensity at Day 7 [ Time Frame: 7 days ]
    change of pain intensity at Day 7, measured by "average pain for the last 24 hours" (NRS 0-10).

Secondary Outcome Measures :
  1. fatigue [ Time Frame: 7 days ]
    change of fatigue measured by EORTC QLQ30 and ESAS

  2. appetite [ Time Frame: 7 days ]
    change of appetite measured by EORTC QLQ30 and ESAS

  3. Overall effect satisfaction [ Time Frame: 7 days ]
    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).

  4. sleep quality [ Time Frame: 7 days ]
    change of sleep quality measured by Pittsburgh Sleep Quality Index

  5. analgesic usage [ Time Frame: 7 days ]
    change of analgesic usage measured by morphine equivalents.

  6. Pain now and average pain last 24 hrs [ Time Frame: 7 days ]
    Pain now and average pain last 24 hours measured by daily NRS (Numeric rating scale)(ESAS)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00676936

Haraldsplass Diakonale sykehus
Bergen, Norway, 5009
Sykehuset Buskerud HF
Drammen, Norway, 3004
Sørlandet Sykehus HF
Kristiansand, Norway, 4606
Oslo Universitetssykehus, Ulleval
Oslo, Norway, 0407
Sykehuset Telemark HF
Skien, Norway, 3712
St Olavs Hospital HF
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
Study Director: Stein Kaasa, MD PhD prof Norwegian University of Science and Technology

Publications of Results:
Responsible Party: Norwegian University of Science and Technology Identifier: NCT00676936     History of Changes
Other Study ID Numbers: OPI 07-005
2007-005617-19 ( EudraCT Number )
First Posted: May 13, 2008    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016

Keywords provided by Norwegian University of Science and Technology:
supportive care
Cancer patients with pain

Additional relevant MeSH terms:
Cancer Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents