The effect of melatonin on insomnia of cancer patients

A double-blind, placebo-controlled study for efficacy and safety of prolonged release melatonin on insomnia of cancer patients

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0003362

Enrollment

Registered

2018-11-21

Start date

2019-01-14

Completion date

Unknown

Last updated

2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Double-blind, placebo-controlled randomized trials. Circadin 2mg will be prescribed with the instruction of taking 8 hours beofre wake-up time and going to bed 2 hours later for 8 weeks to the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Same and over 55 years old 2. Diagnosed with cancer within 3 years 3. No metastasis, within stage 3 of cancer 4. Insomnia Severity Index > 9

Exclusion criteria

Exclusion criteria: - Major psychiatric illness such as schizophrenia, bipolar disorder, or major depressive disorders - Other sleep disorders such as obstructive sleep apnea or restless legs syndrome - Pharmachological or non-pharmacological treatment for insomnia during recent 3 months - Metastasis - Maintenace of steroid or paychiatric medication - Changes in the dosage of opioid during recent 3 months - Major medical illness such as cerebro-vascular disease, cardiac disease, renal failure, hepatic failure, or respiratory disease - Pregnant or breast-feeding

Design outcomes

Primary

Measure	Time frame
The proportion of Insomnia Severity Index =<9 / significant decrease in Insomnia Severity Index	—

Secondary

Measure	Time frame
Subjective satisfaction with Circadin / Improvement in QOL	—

Countries

Korea, Republic of

Contacts

Public ContactSeockhoon Chung

University of Ulsan

schung@amc.seoul.kr+82-2-3010-3411

Outcome results