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Corticosteroids for Cancer Pain

Primary Purpose

Cancer, Pain

Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Methylprednisolone
Placebo
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Cancer, pain, corticosteroids, palliative, supportive care, Cancer patients with pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Haraldsplass Diakonale sykehus
  • Sykehuset Buskerud HF
  • Sørlandet Sykehus HF
  • Oslo Universitetssykehus, Ulleval
  • Sykehuset Telemark HF
  • St Olavs Hospital HF

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Methylprednisolone

Placebo

Arm Description

Methylprednisolone 16 mg twice daily

Placebo capsules twice daily

Outcomes

Primary Outcome Measures

pain intensity at Day 7
change of pain intensity at Day 7, measured by "average pain for the last 24 hours" (NRS 0-10).

Secondary Outcome Measures

fatigue
change of fatigue measured by EORTC QLQ30 and ESAS
appetite
change of appetite measured by EORTC QLQ30 and ESAS
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).
sleep quality
change of sleep quality measured by Pittsburgh Sleep Quality Index
analgesic usage
change of analgesic usage measured by morphine equivalents.
Pain now and average pain last 24 hrs
Pain now and average pain last 24 hours measured by daily NRS (Numeric rating scale)(ESAS)

Full Information

First Posted
May 8, 2008
Last Updated
August 30, 2020
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT00676936
Brief Title
Corticosteroids for Cancer Pain
Official Title
Corticosteroids for Cancer Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Pain
Keywords
Cancer, pain, corticosteroids, palliative, supportive care, Cancer patients with pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylprednisolone
Arm Type
Experimental
Arm Description
Methylprednisolone 16 mg twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules twice daily
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
Medrol (TM)
Intervention Description
Custom made capsules, Methylprednisolone 16 mg twice daily, intervention period 7 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Custom made capsules, Lactose, administered twice daily, intervention period 7 days
Primary Outcome Measure Information:
Title
pain intensity at Day 7
Description
change of pain intensity at Day 7, measured by "average pain for the last 24 hours" (NRS 0-10).
Time Frame
7 days
Secondary Outcome Measure Information:
Title
fatigue
Description
change of fatigue measured by EORTC QLQ30 and ESAS
Time Frame
7 days
Title
appetite
Description
change of appetite measured by EORTC QLQ30 and ESAS
Time Frame
7 days
Title
Overall effect satisfaction
Description
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
Title
sleep quality
Description
change of sleep quality measured by Pittsburgh Sleep Quality Index
Time Frame
7 days
Title
analgesic usage
Description
change of analgesic usage measured by morphine equivalents.
Time Frame
7 days
Title
Pain now and average pain last 24 hrs
Description
Pain now and average pain last 24 hours measured by daily NRS (Numeric rating scale)(ESAS)
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stein Kaasa, MD PhD prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Haraldsplass Diakonale sykehus
City
Bergen
ZIP/Postal Code
5009
Country
Norway
Facility Name
Sykehuset Buskerud HF
City
Drammen
ZIP/Postal Code
3004
Country
Norway
Facility Name
Sørlandet Sykehus HF
City
Kristiansand
ZIP/Postal Code
4606
Country
Norway
Facility Name
Oslo Universitetssykehus, Ulleval
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Facility Name
Sykehuset Telemark HF
City
Skien
ZIP/Postal Code
3712
Country
Norway
Facility Name
St Olavs Hospital HF
City
Trondheim
ZIP/Postal Code
7006
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
25002731
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.
Results Reference
result
PubMed Identifier
32856209
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.
Results Reference
result

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Corticosteroids for Cancer Pain

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