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

Abstract

Purpose: Although 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.

Methods: Patient-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.

Results: Fifty 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.

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

Trial registration: Clinical trial information NCT00676936 (13.05.2008).

Keywords: Advanced cancer; Corticosteroids; Randomized controlled trial; Sleep.

Conflict of interest statement

Marianne Jensen Hjermstad, Jan Henrik Rosland, Nina Aass, Eva Albert, Peter Fayers, and Pål Klepstad have nothing to disclose. Ørnulf Paulsen has received PhD grant from the Telemark Hospital Trust and the South-Eastern Norway Regional Health Authority. Gunnhild Jakobsen has received PhD grant from the Liaison Committee between the Central Norway Regional Health Authority (RHA) and the Norwegian University of Science and Technology (NTNU). Morten Engstrøm has received lecture fees and support for travel from ResMed and Philips. Stein Kaasa is one of the shareholders in Eir Solution A/S and has research funding from Nutricia for other studies. The authors declare no income, dividend, or financial benefits from the work presented here.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram of the progress through the phases of the trial. The figure reports the essentials for analysis of sleep and is adapted from the diagram in the original trial [27]
Fig. 2
Fig. 2
Mean score of QLQ-C30 sleep item according to treatment arm. A higher score represents more sleeping trouble. There were no statistically significant difference in change of sleep problems between the treatment arms (error bars 95% CI)

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