Healia Clinical Trials Information Database

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.


All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.

The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


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