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Corticosteroids for Cancer Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00676936
First received: May 8, 2008
Last updated: February 2, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention Phase
Cancer
Pain
 Drug: Methylprednisolone
Drug: Placebo
 Phase 3

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
Official Title: Corticosteroids for Cancer Pain

Resource links provided by NLM:

MedlinePlus related topics: Cancer Steroids
U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • pain intensity at Day 7 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    change of pain intensity at Day 7, measured by "average pain for the last 24 hours" (NRS 0-10).


Secondary Outcome Measures:
  • fatigue [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    change of fatigue measured by EORTC QLQ30 and ESAS

  • appetite [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    change of appetite measured by EORTC QLQ30 and ESAS

  • Overall effect satisfaction [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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).

  • sleep quality [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    change of sleep quality measured by Pittsburgh Sleep Quality Index

  • analgesic usage [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    change of analgesic usage measured by morphine equivalents.

  • Pain now and average pain last 24 hrs [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Pain now and average pain last 24 hours measured by daily NRS (Numeric rating scale)(ESAS)


Enrollment: 50
Study Start Date: April 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676936

Locations
Norway
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
Investigators
Study Director: Stein Kaasa, MD PhD prof Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00676936     History of Changes
Other Study ID Numbers: OPI 07-005, 2007-005617-19
Study First Received: May 8, 2008
Last Updated: February 2, 2012
Health Authority: Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics

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

Additional relevant MeSH terms:
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013