Corticosteroids for Cancer Pain

Pain Clinical Trial

Official title:

Corticosteroids for Cancer Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676936
• Other study ID #: OPI 07-005
• Secondary ID: 2007-005617-19
• Status: Completed
• Phase: Phase 3
• Start date: April 2008
• Est. completion date: February 2012

Study information

• Verified date: August 2020
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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, methotrexate, ciclofosfamide, rifampicin, aprepitant and diltiazem.

Related Conditions & MeSH terms

• Cancer
• Cancer Pain
• Pain

Intervention

Drug:
• Methylprednisolone
Custom made capsules, Methylprednisolone 16 mg twice daily, intervention period 7 days.
• Placebo
Custom made capsules, Lactose, administered twice daily, intervention period 7 days

Locations

Country	Name	City	State
Norway	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

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Jakobsen G, Engstrøm M, Hjermstad MJ, Rosland JH, Aass N, Albert E, Kaasa S, Fayers P, Klepstad P, Paulsen Ø. The short-term impact of methylprednisolone on patient-reported sleep in patients with advanced cancer in a randomized, placebo-controlled, doubl — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain intensity at Day 7	change of pain intensity at Day 7, measured by "average pain for the last 24 hours" (NRS 0-10).	7 days
Secondary	fatigue	change of fatigue measured by EORTC QLQ30 and ESAS	7 days
Secondary	appetite	change of appetite measured by EORTC QLQ30 and ESAS	7 days
Secondary	Overall effect satisfaction	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).	7 days
Secondary	sleep quality	change of sleep quality measured by Pittsburgh Sleep Quality Index	7 days
Secondary	analgesic usage	change of analgesic usage measured by morphine equivalents.	7 days
Secondary	Pain now and average pain last 24 hrs	Pain now and average pain last 24 hours measured by daily NRS (Numeric rating scale)(ESAS)	7 days