Melatonin for sleep disturbance in breast cancer patients

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001284156

Enrollment

Registered

2019-09-18

Start date

2022-09-01

Completion date

2024-09-30

Last updated

2022-10-10

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

Conditions

None listed

Brief summary

The purpose of this study is to see if melatonin supplementation can help improve sleep in women receiving hormone blocking therapy for breast cancer. Who is it for? You may be eligible for this study if you are aged 18 or over, have stage 1-3 breast cancer, are taking hormone blocking therapy and have trouble sleeping. Study details Participants in this study will be randomised by chance into two groups. One group will take melatonin tablets every evening before bed for 12 weeks. The other group will take a placebo tablet every evening before bed for 12 weeks. Neither the participants nor the researchers will know which participants are taking which tablets. All participants will complete questionnaires, complete a medication diary and wear an atigraph watch to measure your sleep. It is hoped this research will demonstrate the usefulness of melatonin in improving sleep in breast cancer patients.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

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

Outcome results