Pharmacological Treatment of Insomnia in Palliative Care

NCT02807922 | Completed Phase 4

• 2 other identifiers: SleepRCT_2702152015-005306-11
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 5

Brief Summary

Sleep disturbance is frequent in patients with advanced cancer and decreases the tolerability of other symptoms and impairs quality of life. A detailed description of sleep disturbance and its association with other symptoms, and intervention studies on sleep medications are scarce in patients with advanced cancer. A well-designed randomized controlled trial is needed to determine the short time effectiveness of zopiclone on sleep quality, one of the currently available therapies of insomnia, and further to contribute to the clinical management of insomnia in patients with advanced cancer.

Conditions

Sleep; Insomnia

Keywords

Palliative Care; zopiclone

Outcome Measures

Primary Outcomes (1)

• Patient-reported sleep quality

  Primary endpoint is patient-reported sleep quality during the final study night (night six) assessed on a numerical rating scale (NRS) 0-10. 0= Best sleep, 10=Worst possible sleep.

  Night six (last study night)

Secondary Outcomes (2)

• Patient reported total sleep time

  Night six (last study night)

• Patient reported sleep onset latency

  Night six (last study night)

Study Arms (2)

Zopiclone

ACTIVE COMPARATOR

Zopiclone six nights

Drug: Zopiclone

Placebo

PLACEBO COMPARATOR

Placebo six nights

Drug: Placebo

Interventions

Zopiclone DRUG

Zopiclone

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically verified malignant disease
• Presence of metastatic / disseminated disease
• Presence of insomnia syndrome defined as:
• Self-reported difficulty with initiating sleep (greater than 30 minutes to sleep onset) and/or difficulty maintaining sleep (greater than 30 minutes nocturnal waking time); and
• Sleep difficulty at least 3 nights per week; and
• Sleep difficulty that causes significant impairment of daytime functioning (The patient will be asked if sleep difficulty result in altered daytime function i.e. feeling tired, lack of energy)
• Able to comply with all study procedures
• Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.

You may not qualify if:

• On-going treatment or previous treatment (within last 4 weeks) for more than consecutive 3 days with medications given for insomnia
• Adverse reactions to zopiclone
• History of substance abuse
• Concomitant use of rifampicin and erythromycin
• Any other contraindication listed on the summary of product characteristics of the investigated medicinal product:
• Myasthenia gravis
• An established diagnosis of Severe impairment of respiratory function
• An established diagnosis of Severe hepatic insufficiency.(Child-Pugh grade B or C)
• An established diagnosis of sleep apnea
• Known hypersensitivity to the drug or to any component in its formulation: Lactose monohydrate, Calcium hydrogen phosphate, Maize starch, Croscarmellose sodium, Magnesium stearate, Titanium dioxide (E 171), Hypromellose, Iron oxide yellow/Iron oxide red (E 172) and Macrogol
• Unfit for participation for any reason as judged by the investigator
• Pregnancy or lactation
• Women of reproductive age not willing or unable to employ an effective method of contraception (sterilization, using IUD or oral contraception)
• Scheduled surgery within the next week
• In the need of change in scheduled opioid dose at baseline (study visit 1)

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (5)

Sunniva senter for lindrende behandling, Haraldsplass Diakonale sykehus

Bergen, 5892, Norway

Location

sykehuset Levanger

Levanger, 7601, Norway

Location

Helse Sør-Øst RHF, Sykehuset i Telemark,

Skien, 3710, Norway

Location

St. Olavs Hospital

Trondheim, 7006, Norway

Location

Helse Sør-Øst RHF, Sykehuset i Vestfold,

Tønsberg, 3103, Norway

Location

Related Publications (2)

• Jakobsen G, Engstrom M, Paulsen O, Sjue K, Raj SX, Thronaes M, Hjermstad MJ, Kaasa S, Fayers P, Klepstad P. Zopiclone versus placebo for short-term treatment of insomnia in patients with advanced cancer: study protocol for a double-blind, randomized, placebo-controlled, clinical multicenter trial. Trials. 2018 Dec 27;19(1):707. doi: 10.1186/s13063-018-3088-3.

  PMID: 30591073 BACKGROUND

• Jakobsen G, Sjue K, Paulsen O, Kaasa S, Hjermstad MJ, Klepstad P. 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. Support Care Cancer. 2022 Dec 19;31(1):60. doi: 10.1007/s00520-022-07537-x.

  PMID: 36534165 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

zopiclone

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Pål Klepstad

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: June 21, 2016
• Study Start: November 15, 2016
• Primary Completion: July 13, 2021
• Study Completion: July 13, 2021
• Last Updated: July 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (5)