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CancerPhase 3NCT00676936

Corticosteroids for Cancer Pain

A Phase 3 study testing Methylprednisolone in people with Cancer and Pain, run by Norwegian University of Science and Technology at 6 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Pain
What is being tested?
Methylprednisolone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
6 sitesNorway
Study dates
Apr 2008to Feb 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Norway6 sites

  • Haraldsplass Diakonale sykehus

    Bergen, 5009

  • Sykehuset Buskerud HF

    Drammen, 3004

  • Sørlandet Sykehus HF

    Kristiansand, 4606

  • Oslo Universitetssykehus, Ulleval

    Oslo, 0407

  • Sykehuset Telemark HF

    Skien, 3712

  • St Olavs Hospital HF

    Trondheim, 7006

Other trials in Norway

About this study

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).

Read the 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
Being tested
Methylprednisolone, Placebo
Keywords
Cancer, pain, corticosteroids, palliative, supportive care, Cancer patients with pain
Medical subject headings
Neoplasms, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethylprednisoloneDrug

    Also called Medrol (TM)

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

  • PlaceboDrug

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

Study groups in NCT00676936
Study groupRoleWhat they receive
MethylprednisoloneExperimentalMethylprednisolone 16 mg twice daily
Receives: Drug: Methylprednisolone
PlaceboPlacebo comparatorPlacebo capsules twice daily
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pain intensity at Day 7

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

    Measured: 7 days

Secondary outcomes (6)

  1. fatigue

    change of fatigue measured by EORTC QLQ30 and ESAS

    Measured: 7 days

  2. appetite

    change of appetite measured by EORTC QLQ30 and ESAS

    Measured: 7 days

  3. 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).

    Measured: 7 days

  4. sleep quality

    change of sleep quality measured by Pittsburgh Sleep Quality Index

    Measured: 7 days

  5. analgesic usage

    change of analgesic usage measured by morphine equivalents.

    Measured: 7 days

  6. Pain now and average pain last 24 hrs

    Pain now and average pain last 24 hours measured by daily NRS (Numeric rating scale)(ESAS)

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00676936
Sponsor's protocol ID
OPI 07-005
Other IDs
2007-005617-19
Status last verified
Aug 2020
First submitted
8 May 2008
Last updated
1 Sep 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25002731

  • 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.

    PubMed 32856209

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methylprednisolone in people with Cancer and Pain, run by Norwegian University of Science and Technology at 6 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain intensity at Day 7 (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00676936, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.

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