Clinical trial NCT00676936: Corticosteroids for Cancer Pain
Official title: Corticosteroids for Cancer Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Pain
Keywords: Cancer
pain
corticosteroids
palliative
supportive care
Cancer patients with pain
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2008-05-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: pain intensity at Day 7
timeFrame: 7 days
Secondary outcomes:
measure: fatigue
timeFrame: 7 days
measure: appetite
timeFrame: 7 days
measure: Overall effect satisfaction
timeFrame: 7 days
measure: sleep quality
timeFrame: 7 days
measure: analgesic usage
timeFrame: 7 days
measure: Pain now and average pain last 24 hrs
timeFrame: 7 days
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haraldsplass Diakonale sykehus
city: Drammen
country: Norway
facility: Sykehuset Buskerud HF
city: Kristiansand
country: Norway
facility: Sørlandet Sykehus HF
city: Oslo
country: Norway
facility: Oslo Universitetssykehus, Ulleval
city: Skien
country: Norway
facility: Sykehuset Telemark HF
city: Trondheim
country: Norway
facility: St Olavs Hospital HF
Study officials:
affiliation: Norwegian University of Science and Technology
name: Stein Kaasa, MD PhD prof
role: STUDY_DIRECTOR
References:
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. 2014 Oct 10;32(29):3221-8. doi: 10.1200/JCO.2013.54.3926. Epub 2014 Jul 7.
citation: 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.