Corticosteroids for Cancer Pain - Full Text View

Sponsor:	Norwegian University of Science and Technology
Information provided by (Responsible Party):	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00676936

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 III

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

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone Corticosteroids

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: The National Committees for Research Ethics in Norway

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 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 February 09, 2012