Dataset Information

Zopiclone versus placebo for short-term treatment of insomnia in patients with advanced cancer-a double-blind, randomized placebo-controlled clinical multicenter phase IV trial.

ABSTRACT:

Purpose

Insomnia is frequent in patients with advanced cancer, and a variety of pharmacological agents is used to treat this condition. Still, few clinical trials have investigated the effectiveness of pharmacological sleep therapies in this patient group. We aimed to study the short-term effectiveness of zopiclone on sleep quality in patients with advanced cancer who report insomnia.

Methods

A randomized, double-blind, placebo-controlled, parallel-group, multicenter, phase IV clinical trial in adult patients with metastatic malignant disease and insomnia. Patients were treated with zopiclone or placebo for six subsequent nights. Primary end point was patient-reported sleep quality during the final study night (NRS 0-10). Secondary end points were patient-reported sleep onset latency (SOL) and total sleep time (TST).

Results

Forty-one patients were randomized, with 18 being analyzed in the zopiclone group and 21 in the placebo group. Median age was 66, median Karnofsky performance score was 80, and 56% were male. Mean sleep quality at end of study was 2.9 (CI 2.3 to 3.8) in the zopiclone group and 4.5 (CI 3.6 to 5.4) in the placebo group (p = 0.021). At end of study, SOL was significantly different between the treatment groups: zopiclone 29 min (CI 13 to 51) and placebo 62 min (CI 40 to 87) (p = 0.045). TST was not significantly different across groups: zopiclone 449 min (403 to 496) and placebo 411 min (CI 380 to 440) (p = 0.167).

Conclusion

Zopiclone improved short-term patient-reported sleep quality in this cohort of patients with advanced cancer.

Trial registration

ClinicalTrials.gov Identifier: NCT02807922.

SUBMITTER: Jakobsen G

PROVIDER: S-EPMC9763131 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

Zopiclone versus placebo for short-term treatment of insomnia in patients with advanced cancer-a double-blind, randomized placebo-controlled clinical multicenter phase IV trial.

Jakobsen Gunnhild G Sjue Karin K Paulsen Ørnulf Ø Kaasa Stein S Hjermstad Marianne Jensen MJ Klepstad Pål P

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer 20221219 1

<h4>Purpose</h4>Insomnia is frequent in patients with advanced cancer, and a variety of pharmacological agents is used to treat this condition. Still, few clinical trials have investigated the effectiveness of pharmacological sleep therapies in this patient group. We aimed to study the short-term effectiveness of zopiclone on sleep quality in patients with advanced cancer who report insomnia.<h4>Methods</h4>A randomized, double-blind, placebo-controlled, parallel-group, multicenter, phase IV cli ...[more]

PMID: 36534165

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Dataset Information

Zopiclone versus placebo for short-term treatment of insomnia in patients with advanced cancer-a double-blind, randomized placebo-controlled clinical multicenter phase IV trial.

Purpose

Methods

Results

Conclusion

Trial registration

Publications

Zopiclone versus placebo for short-term treatment of insomnia in patients with advanced cancer-a double-blind, randomized placebo-controlled clinical multicenter phase IV trial.

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