The short-term impact of methylprednisolone on patient-reported sleep in patients with advanced cancer in a randomized,
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ORIGINAL ARTICLE
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 1,2 & Morten Engstrøm 3,4 & Marianne Jensen Hjermstad 5,6,7 & Jan Henrik Rosland 8,9 & Nina Aass 5,10 & Eva Albert 11 & Stein Kaasa 1,6,7 & Peter Fayers 12 & Pål Klepstad 13,14 & Ørnulf Paulsen 6,7,15 Received: 3 April 2020 / Accepted: 19 August 2020 # The Author(s) 2020
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, doubleblind 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 Corticosteroids . Sleep . Advanced cancer . Randomized controlled trial
* Gunnhild Jakobsen [email protected] Morten Engstrøm [email protected] Marianne Jensen Hjermstad [email protected] Jan Henrik Rosland [email protected] Nina Aass [email protected]
Eva Albert [email protected] Stein Kaasa [email protected] Peter Fayers [email protected] Pål Klepstad [email protected] Ørnulf Paulsen [email protected] Extended author information available on the last page of the article
Support Care Cancer
Background Patients with advanced cancer often report poor sleep quality with a prevalence that varies from 40 to 96% across studies [1–6]. The cancer disease and the cancer treatments are factors that probably contribute to sleep disturbances [7]. Treatment with corticosteroids may be a precipitating factor involved in the development of insomnia in patie
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