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Trial registered on ANZCTR


Registration number
ACTRN12619001284156
Ethics application status
Approved
Date submitted
19/03/2019
Date registered
18/09/2019
Date last updated
4/10/2022
Date data sharing statement initially provided
18/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Melatonin for sleep disturbance in breast cancer patients
Scientific title
Phase II randomised control trial of melatonin versus placebo for the management of sleep disturbance in women with early stage breast cancer on adjuvant endocrine therapy
Secondary ID [1] 297753 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 312090 0
Sleep Disturbance 312091 0
Condition category
Condition code
Cancer 310649 310649 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral melatonin slow release 2mg tablets taken daily 1-2 hours before bedtime for 12 weeks

Participants will complete a medication diary and pill counts will be performed
Intervention code [1] 313992 0
Treatment: Drugs
Comparator / control treatment
Oral placebo tablet taken daily 1-2 hours before bed-time for 12 weeks

Participants will complete a medication diary and pill counts will be performed
Control group
Placebo

Outcomes
Primary outcome [1] 319497 0
To determine the effect of melatonin on sleep quality (proportion of women with >=3 point decrease in Pittsburgh Sleep Quality Index)
Timepoint [1] 319497 0
12 weeks (post-treatment)
Secondary outcome [1] 368471 0
To determine the proportion who become ‘good sleepers’ (Pittsburgh Sleep Quality Index score <5)
Timepoint [1] 368471 0
12 weeks (post-treatment), 24 weeks (follow-up)
Secondary outcome [2] 374716 0
To determine subjective improvement in sleep quality (proportion of women reporting improvement in sleep)
Timepoint [2] 374716 0
12 weeks (post-treatment)
Secondary outcome [3] 374725 0
To determine the impact on the sleep wake cycle (sleep regularity index measured by actigraphy)
Timepoint [3] 374725 0
12 weeks (post-treatment)
Secondary outcome [4] 374726 0
To determine change in sleep quality at 24 weeks using the PSQI score
Timepoint [4] 374726 0
24 weeks (follow-up)
Secondary outcome [5] 374727 0
To determine adherence to melatonin using a medication diary and pill count
Timepoint [5] 374727 0
6 weeks (mid-treatment), 12 weeks (post-treatment), 24 weeks (follow-up)
Secondary outcome [6] 374728 0
To determine adherence to endocrine therapy using the medication diary
Timepoint [6] 374728 0
6 weeks (mid-treatment), 12 weeks (post-treatment), 24 weeks (follow-up)
Secondary outcome [7] 374729 0
To determine the use of other rescue medications for sleep using the Medication diary
Timepoint [7] 374729 0
6 weeks (mid-treatment), 12 weeks (post-treatment), 24 weeks (follow-up)
Secondary outcome [8] 374730 0
To determine the use of alcohol for sleep using the Medication diary
Timepoint [8] 374730 0
6 weeks (mid-treatment), 12 weeks (post-treatment), 24 weeks (follow-up)
Secondary outcome [9] 374731 0
To determine safety and adverse event rate using CTCAE v5.0
Timepoint [9] 374731 0
6 weeks (mid-treatment), 12 weeks (post-treatment)
Secondary outcome [10] 374732 0
To determine change in quality of life using the FACT-ES questionnaire
Timepoint [10] 374732 0
6 weeks (mid-treatment), 12 weeks (post-treatment), 24 weeks (follow-up)
Secondary outcome [11] 374733 0
To determine change in fatigue using the FACT-F questionnaire subscale
Timepoint [11] 374733 0
6 weeks (mid-treatment), 12 weeks (post-treatment), 24 weeks (follow-up)
Secondary outcome [12] 374734 0
To determine change in cognitive impairment using the FACT-Cog questionnaire
Timepoint [12] 374734 0
12 weeks (post-treatment), 24 weeks (follow-up)
Secondary outcome [13] 374735 0
To determine change in anxiety and depression using the HADS score
Timepoint [13] 374735 0
6 weeks (mid-treatment), 12 weeks (post-treatment), 24 weeks (follow-up)
Secondary outcome [14] 374736 0
To determine change in distress using the distress thermometer
Timepoint [14] 374736 0
6 weeks (mid-treatment), 12 weeks (post-treatment), 24 weeks (follow-up)

Eligibility
Key inclusion criteria
a) Age >=18 years
b) Female
c) Stage I-III breast cancer
d) Stable on adjuvant endocrine therapy for >=3 months with:
i. Aromatase inhibitor (letrozole, anastrozole or exemestane)
ii. Tamoxifen
iii. +/- ovarian suppression with gonadotropin releasing hormone agonist
e) Completed primary adjuvant breast cancer treatment (surgery +/- chemotherapy +/- radiotherapy) >=6 months previously (patients can still be receiving adjuvant trastuzumab)
f) ECOG 0-2
g) Self-reported sleep disturbance that started or worsened after breast cancer diagnosis or commencing endocrine therapy
h) Poor sleep quality defined as PSQI score >=5
i) Willing and able to complete study questionnaires in English
j) Written informed consent to participate in the trial
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Metastatic breast cancer (stage IV)
b) Currently on hormone replacement therapy (HRT) or oral contraceptive pill (OCP)
c) Diagnosis of obstructive sleep apnoea or other sleep disorder
d) Use of melatonin or other pharmaceutical interventions for sleep <=14 days of study enrolment e.g. benzodiazepines, zolpidem or zopiclone
e) Working >1 overnight shift per fortnight on a regular basis
f) Pregnant or breastfeeding
g) Use of warfarin if INR <1 or >4 (sub- therapeutic or supra-therapeutic INR)
h) Uncontrolled seizure disorder
i) Started new anti-depressant medication or dose change of existing anti-depressant medication within last 3 months
j) Currently on agomelatin (Valdoxan) (due to interaction with melatonin)
k) Severe renal impairment with estimated glomerular filtration rate (eGFR) <30
l) Decompensated liver cirrhosis or hepatic impairment with raised bilirubin >=3x ULN and/or raised alanine aminotransferase or aspartate aminotransferase >=5x ULN
m) Known hypersensitivity or allergy to melatonin

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Double blind study. Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation 2:1 to melatonin versus placebo
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/08/2020
Actual
1/09/2022
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
51
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13451 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 13452 0
Macarthur Cancer Therapy Centre - Campbelltown
Recruitment hospital [3] 23293 0
Southern Highlands Private Hospital - Bowral
Recruitment hospital [4] 23294 0
The Northern Beaches Hospital - Frenchs Forest
Recruitment postcode(s) [1] 26056 0
2139 - Concord
Recruitment postcode(s) [2] 26057 0
2560 - Campbelltown
Recruitment postcode(s) [3] 38666 0
2576 - Bowral
Recruitment postcode(s) [4] 38667 0
2086 - Frenchs Forest

Funding & Sponsors
Funding source category [1] 302277 0
Other Collaborative groups
Name [1] 302277 0
Breast Cancer Trials Group
Country [1] 302277 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 302152 0
None
Name [1] 302152 0
Address [1] 302152 0
Country [1] 302152 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302953 0
Sydney Local Health District Human Research Ethics Committee - Concord Repatriation General Hospital
Ethics committee address [1] 302953 0
Ethics committee country [1] 302953 0
Australia
Date submitted for ethics approval [1] 302953 0
06/05/2019
Approval date [1] 302953 0
10/10/2019
Ethics approval number [1] 302953 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91962 0
Dr Emma-Kate Carson
Address 91962 0
Concord Repatriation General Hospital
Hospital Road
Concord, 2139
NSW
Country 91962 0
Australia
Phone 91962 0
+61 2 9767 6354
Fax 91962 0
+61 2 9767 5764
Email 91962 0
emmakate.carson@health.nsw.gov.au
Contact person for public queries
Name 91963 0
Emma-Kate Carson
Address 91963 0
Concord Repatriation General Hospital
Hospital Road
Concord, 2139
NSW
Country 91963 0
Australia
Phone 91963 0
+61 2 9767 6354
Fax 91963 0
+61 2 9767 5764
Email 91963 0
emmakate.carson@health.nsw.gov.au
Contact person for scientific queries
Name 91964 0
Emma-Kate Carson
Address 91964 0
Concord Repatriation General Hospital
Hospital Road
Concord, 2139
NSW
Country 91964 0
Australia
Phone 91964 0
+61 2 9767 6354
Fax 91964 0
+61 2 9767 5764
Email 91964 0
emmakate.carson@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.