Corticosteroids for Cancer Pain - Full Text View

Sponsored by:	Norwegian University of Science and Technology
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00676936

Purpose

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).

Condition	Intervention	Phase
Cancer Pain	Drug: Methylprednisolone Drug: Placebo	Phase III

MedlinePlus related topics: Cancer

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Corticosteroids for Cancer Pain

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

Primary Outcome Measures:

Primary outcome is reduction in pain intensity at Day 7, measured by "average pain for the last 24 hours" (NRS 0-10). [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improvement of fatigue measured by EORTC QLQ30 and ESAS [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Improvement of appetite measured by EORTC QLQ30 and ESAS. [ 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). [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Improvement of sleep quality measured by Pittsburgh Sleep Quality Index. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Reduction in analgesic usage measured by morphine equivalents. [ 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). [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	55
Study Start Date:	April 2008

Arms	Assigned Interventions
MP: Experimental Methylprednisolone 16 mg twice daily	Drug: Methylprednisolone Custom made capsules, Methylprednisolone 16 mg twice daily, intervention period 7 days.
Placebo: Placebo Comparator Placebo capsules twice daily	Drug: Placebo Custom made capsules, Lactosis, 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 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.

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, methotrexat, ciclofosfamid, rifampicin, aprepitant and diltiazem.

Contacts and Locations

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

Contacts

Contact: Ornulf Paulsen, MD	47-35-003-500	ornulf.paulsen@sthf.no
Contact: marianne aamand, RN	47-35-005-436	marianne.aamand@sthf.no

Locations

Norway
Sykehuset Telemark HF	Recruiting
Skien, Norway, 3712
Contact: Ornulf Paulsen, MD 47-35-003-500 ornulf.paulsen@sthf.no
Contact: Marianne Aamand, RN 47-35-005-436 marianne.aamand@sthf.no
Principal Investigator: Ornulf Paulsen, MD
Sykehuset Buskerud HF	Not yet recruiting
Drammen, Norway, 3004
Contact: Magnar Kvitberg, MD 47-32-803-000 magnar.kvitberg@sb-hf.no
Contact: Gro Buhaug, RN 47-32-803-000 buhg@sb-hf.no
Principal Investigator: Magnar Kvitberg, MD
St Olavs Hospital HF	Not yet recruiting
Trondheim, Norway, 7006
Contact: Frode Skanke, MD 47-73-867-252 frode.skanke@stolav.no
Contact: Vanja Stromsnes, RN 47-73-868-082 vanja.stromsnes@stolav.no
Principal Investigator: Frode Skanke, MD
Haraldsplass Diakonale sykehus	Not yet recruiting
Bergen, Norway, 5009
Contact: Katrin R Sigurdardottir, MD 47-55-979-400 katrin.sigurdardottir@haraldsplass.no
Contact: Grethe S Iversen, RN 47-55-979-400 griv@haraldsplass.no
Principal Investigator: Kathrin R Sigurdardottir, MD
Sørlandet Sykehus HF	Recruiting
Kristiansand, Norway, 4606
Contact: Eva Albert, MD 47-38-146-600 eva.albert@sshf.no
Contact: Mirjam Christensen, RN 47-38-146-600 bente.mirjam.christensen@sshf.no
Principal Investigator: Eva Albert, MD

Sponsors and Collaborators

Norwegian University of Science and Technology

More Information

Responsible Party:	Norwegian University of Science and Technology ( Stein Kaasa )
Study ID Numbers:	OPI 07-005, Eudra CT nr 2007-005617-19
Study First Received:	May 8, 2008
Last Updated:	May 12, 2008
ClinicalTrials.gov Identifier:	NCT00676936
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

Study placed in the following topic categories:

Methylprednisolone
Prednisolone
Methylprednisolone acetate

Prednisolone acetate
Pain
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics
Neuroprotective Agents

Protective Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009