Temazepam or Melatonin Versus Placebo for the Treatment of INsomnia in Advanced CAncer: A Three Arm, Double Blind, Phase III, Multicentre, Randomised Clinical Trial

Phase 3

• Conditions: Insomnia in advance cancer; Cancer - Any cancer

• Registration Number: ACTRN12620000581965
• Lead Sponsor: Western Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-19
• Last Update Posted: 25 May 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Patient has provided written informed consent
Male or female patients aged equal or above 18 years
Presence of advanced cancer of any aetiology
Patient has an Insomnia Severity Score (ISI) above 11
Australian modified Karnofsky performance status equal or above 40%.
Patient is willing and able to comply with the protocol requirements for the duration of the study

Exclusion Criteria

Patient has pain or other unstable symptoms that the clinician and patient feels is directly contributing to poor sleep unless the symptom is optimally treated with no potential to change during the course of the study Patients with unstable symptoms can be re-screened once the symptoms are stable
Patient who has taken any prescription medication for sleep within 3 days prior to randomisation.
Patients on prescription medication for sleep can be re-screened once medication has been ceased for 3 or more days
Concurrent use of benzodiazepines for any indication
Patient has had more than 2 falls in the past week
Patients on varying doses of corticosteroids for any reason during the intervention period or 3 days prior to randomisation
Plan for surgery during the study period
Formally diagnosed active and uncontrolled alcohol or substance abuse disorder Intolerance to melatonin or temazepam
Patient is pregnant or lactating
Unstable psychiatric illness as assessed by the clinician
Any contraindication listed on the product description for temazepam or melatonin
The patient is on another clinical trial of an investigational agent that is likely to interfere with sleep

Study & Design

• Study Type: Interventional
• Study Design: Not specified