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Pharmacological Treatment of Insomnia in Palliative Care

Primary Purpose

Sleep, Insomnia

Status

Completed

Phase

Phase 4

Locations

Norway

Study Type

Interventional

Intervention

Zopiclone

Placebo

About this trial

This is an interventional treatment trial for Sleep focused on measuring Palliative Care, zopiclone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically verified malignant disease
Presence of metastatic / disseminated disease
Presence of insomnia syndrome defined as:
1. 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
2. Sleep difficulty at least 3 nights per week; and
3. 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.

Exclusion Criteria:

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:
1. Myasthenia gravis
2. An established diagnosis of Severe impairment of respiratory function
3. An established diagnosis of Severe hepatic insufficiency.(Child-Pugh grade B or C)
4. An established diagnosis of sleep apnea
5. 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)
Scheduled intravenous administration of chemotherapy during the study period (from baseline to day 8) or intravenous administration of chemotherapy during the last week
Change in corticosteroid dose last week before baseline or planned dose change in corticosteroid dose within 7 days from baseline

Sites / Locations

Sunniva senter for lindrende behandling, Haraldsplass Diakonale sykehus
sykehuset Levanger
Helse Sør-Øst RHF, Sykehuset i Telemark,
St. Olavs Hospital
Helse Sør-Øst RHF, Sykehuset i Vestfold,

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Zopiclone

Placebo

Arm Description

Zopiclone six nights

Placebo six nights

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient reported total sleep time

Patient reported sleep onset latency

Sleep onset latency (how long (minutes) it takes to fall asleep

Full Information

NCT ID

NCT02807922

First Posted

June 17, 2016

Last Updated

July 14, 2021

Sponsor

St. Olavs Hospital

Collaborators

Norwegian University of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT02807922

Brief Title

Pharmacological Treatment of Insomnia in Palliative Care

Official Title

Pharmacological Treatment of Insomnia in Palliative Care: A Randomized, Double-blind, Placebo Controlled, Parallel-group, Multicenter Trial Investigating the Short Time Effect of Zopiclone on Self-reported Sleep Quality in Patients With Advanced Cancer Who Use Opioids and Who Report Insomnia

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

November 15, 2016 (Actual)

Primary Completion Date

July 13, 2021 (Actual)

Study Completion Date

July 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

St. Olavs Hospital

Collaborators

Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

The clinical trial is a randomized, double-blind, placebo controlled, parallel-group, multicenter trial investigating the short time effectiveness of zopiclone on self-reported sleep quality in patients with advanced cancer who use opioids and who report insomnia. Patients with advanced cancer who use opioids and who report insomnia are randomized to either a hypnotic, zopiclone (Arm A) or placebo (Arm B) for six nights. For this study zopiclone Actavis 3.75 mg, 5 mg and 7.5 mg (active comparator) and placebo are defined as Investigational Medicinal Products. The initial dose is zopiclone/placebo 3.75 mg/day. Evaluation of sleep quality is performed in the morning after night 2 and 4 with evaluation of sleep quality by using a numerical rating scale 0-10 with the question "Please circle the number that best describes how you feel now" 0= Best sleep, 10= Worst possible sleep.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep, Insomnia

Keywords

Palliative Care, zopiclone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zopiclone

Arm Type

Active Comparator

Arm Description

Zopiclone six nights

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo six nights

Intervention Type

Drug

Intervention Name(s)

Zopiclone

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Patient-reported sleep quality

Description

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.

Time Frame

Night six (last study night)

Secondary Outcome Measure Information:

Title

Patient reported total sleep time

Time Frame

Night six (last study night)

Title

Patient reported sleep onset latency

Description

Sleep onset latency (how long (minutes) it takes to fall asleep

Time Frame

Night six (last study night)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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) Scheduled intravenous administration of chemotherapy during the study period (from baseline to day 8) or intravenous administration of chemotherapy during the last week Change in corticosteroid dose last week before baseline or planned dose change in corticosteroid dose within 7 days from baseline

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pål Klepstad

Organizational Affiliation

St. Olavs Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sunniva senter for lindrende behandling, Haraldsplass Diakonale sykehus

City

Bergen

ZIP/Postal Code

5892

Country

Norway

Facility Name

sykehuset Levanger

City

Levanger

ZIP/Postal Code

7601

Country

Norway

Facility Name

Helse Sør-Øst RHF, Sykehuset i Telemark,

City

Skien

ZIP/Postal Code

3710

Country

Norway

Facility Name

St. Olavs Hospital

City

Trondheim

ZIP/Postal Code

7006

Country

Norway

Facility Name

Helse Sør-Øst RHF, Sykehuset i Vestfold,

City

Tønsberg

ZIP/Postal Code

3103

Country

Norway

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30591073

Citation

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.

Results Reference

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