Evidence map›Paper›PMID 32856209›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2021

The short-term impact of methylprednisolone on patient-reported sleep in patients with advanced cancer in a randomized, placebo-controlled, double-blind trial.

Gunnhild Jakobsen, Morten Engstrøm, Marianne Jensen Hjermstad, Jan Henrik Rosland, Nina Aass, Eva Albert, Stein Kaasa, Peter Fayers, Pål Klepstad, Ørnulf Paulsen

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00676936 (Corticosteroids for Cancer Pain), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact, top 88% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00676936 phase3completednot on this map

Corticosteroids for Cancer Pain

TypeinterventionalSponsorNorwegian University of Science and TechnologyRan2008 to 2012Enrolled50ConditionsCancer, PainArmsMethylprednisolone, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 1 citations in OpenAlex.

  1. Management of Fatigue in Adult Survivors of Cancer: ASCO-Society for Integrative Oncology Guideline Update.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Guideline
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 2 countries.

Gunnhild JakobsenDepartment of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU Norwegian University of Science and Technology, Postbox 8905, N-7491, Trondheim, Norway. gunnhild.jakobsen@ntnu.no.ORCID http://orcid.org/0000-0002-4914-7623
Morten EngstrømDepartment of Neuromedicine and Movement Science, NTNU - Norwegian University of Science and Technology, Trondheim, Norway.
Marianne Jensen HjermstadRegional Advisory Unit for Palliative Care, Department of Oncology, Oslo University Hospital, Oslo, Norway.
Jan Henrik RoslandDepartment of Clinical Medicine, University of Bergen, Bergen, Norway.
Nina AassRegional Advisory Unit for Palliative Care, Department of Oncology, Oslo University Hospital, Oslo, Norway.
Eva AlbertSørlandet Hospital Kristiansand, Kristiansand, Norway.
Stein KaasaDepartment of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU Norwegian University of Science and Technology, Postbox 8905, N-7491, Trondheim, Norway.
Peter FayersDivision of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.
Pål KlepstadDepartment of Anaesthesiology and Intensive Care Medicine, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.
Ørnulf PaulsenEuropean Palliative Care Research Centre, Department of Oncology, Oslo University Hospital, Oslo, Norway.
Oslo University Hospital · NONorwegian University of Science and Technology · NOSørlandet Sykehus · NOUniversity of Aberdeen · GBUniversity of Bergen · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAlthough corticosteroids are frequently used in patients with advanced cancer, few studies have examined the impact of these drugs on patient-reported sleep. We aimed to examine the short-term impact of methylprednisolone on patient-reported sleep in patients with advanced cancer.

methodsPatient-reported sleep was a predefined secondary outcome in a prospective, randomized, placebo-controlled, double-blind trial that evaluated the analgesic efficacy of corticosteroids in advanced cancer patients (18+), using opioids, and having pain ≥ 4 past 24 h (NRS 0-10). Patients were randomized to the methylprednisolone group with methylprednisolone 16 mg × 2/day or placebo for 7 days. The EORTC QLQ-C30 (0-100) and the Pittsburgh Sleep Quality Index questionnaire (PSQI) (0-21) were used to assess the impact of corticosteroids on sleep at baseline and at day 7.

resultsFifty patients were randomized of which 25 were analyzed in the intervention group and 22 in the control group. Mean age was 64 years, mean Karnofsky performance status was 67 (SD 13.3), 51% were female, and the mean oral daily morphine equivalent dose was 223 mg (SD 222.77). Mean QLQ-C30 sleep score at baseline was 29.0 (SD 36.7) in the methylprednisolone group and 24.2 (SD 27.6) in the placebo group. At day 7, there was no difference between the groups on QLQ-C30 sleep score (methylprednisolone 20.3 (SD 32.9); placebo 28.8 (SD 33.0), p = 0.173). PSQI showed similar results.

conclusionsMethylprednisolone 16 mg twice daily for 7 days had no impact on patient-reported sleep in this cohort of patients with advanced cancer.

trial registrationClinical trial information NCT00676936 (13.05.2008).

Indexed as

Patient Reported Outcome MeasuresDouble-Blind MethodFemaleHumansMaleMethylprednisoloneMiddle AgedNeoplasmsProspective StudiesSleepSurveys and QuestionnairesTreatment OutcomeMethylprednisoloneAdvanced cancerCorticosteroidsRandomized controlled trialSleep

Identifiers

PMID32856209
PMCPMC7892512
OpenAlexW3081779707

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.