Corticosteroids for Cancer Pain

NCT ID: NCT00676936

Last Updated: 2020-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2012-02-29

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).

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.

Conditions

Cancer; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Methylprednisolone

Methylprednisolone 16 mg twice daily

Group Type: EXPERIMENTAL

Methylprednisolone

Intervention Type: DRUG

Custom made capsules, Methylprednisolone 16 mg twice daily, intervention period 7 days.

Placebo

Placebo capsules twice daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Custom made capsules, Lactose, administered twice daily, intervention period 7 days

Interventions

Methylprednisolone

Custom made capsules, Methylprednisolone 16 mg twice daily, intervention period 7 days.

Intervention Type: DRUG

Placebo

Custom made capsules, Lactose, administered twice daily, intervention period 7 days

Intervention Type: DRUG

Other Intervention Names

Medrol (TM)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stein Kaasa, MD PhD prof

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

Haraldsplass Diakonale sykehus

Bergen, , Norway

Sykehuset Buskerud HF

Drammen, , Norway

Sørlandet Sykehus HF

Kristiansand, , Norway

Oslo Universitetssykehus, Ulleval

Oslo, , Norway

Sykehuset Telemark HF

Skien, , Norway

St Olavs Hospital HF

Trondheim, , Norway

Countries

Norway

References

Paulsen O, Klepstad P, Rosland JH, Aass N, Albert E, Fayers P, Kaasa S. Efficacy of methylprednisolone on pain, fatigue, and appetite loss in patients with advanced cancer using opioids: a randomized, placebo-controlled, double-blind trial. J Clin Oncol. 2014 Oct 10;32(29):3221-8. doi: 10.1200/JCO.2013.54.3926. Epub 2014 Jul 7.

Reference Type: RESULT

PMID: 25002731 (View on PubMed)

Jakobsen G, Engstrom M, Hjermstad MJ, Rosland JH, Aass N, Albert E, Kaasa S, Fayers P, Klepstad P, Paulsen O. The short-term impact of methylprednisolone on patient-reported sleep in patients with advanced cancer in a randomized, placebo-controlled, double-blind trial. Support Care Cancer. 2021 Apr;29(4):2047-2055. doi: 10.1007/s00520-020-05693-6. Epub 2020 Aug 27.

Reference Type: RESULT

PMID: 32856209 (View on PubMed)

Other Identifiers

2007-005617-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

OPI 07-005

Identifier Type: -

Identifier Source: org_study_id