Trial Outcomes & Findings for Melatonin Versus Placebo in Breast Cancer (NCT NCT01805089)

NCT ID: NCT01805089

Last Updated: 2015-03-23

Results Overview

Absolute plasma estradiol levels after 4 month course of melatonin or placebo, only 4 month level provided below.

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 95 participants
• Primary outcome timeframe: 4 months
• Results posted on: 2015-03-23

Participant Flow

Participant milestones

Measure	Melatonin 3mg Taken orally, once per day, at/around 9:00pm Melatonin	Placebo Taken orally, once per day, at/around 9:00pm Placebo
Overall Study STARTED	48	47
Overall Study COMPLETED	43	43
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Melatonin Versus Placebo in Breast Cancer

Baseline characteristics by cohort

Measure	Melatonin n=48 Participants Taken orally, once per day, at/around 9:00pm Melatonin	Placebo n=47 Participants Taken orally, once per day, at/around 9:00pm Placebo	Total n=95 Participants Total of all reporting groups
Age, Continuous	58 years n=5 Participants	60 years n=7 Participants	59 years n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	47 Participants n=7 Participants	95 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	46 participants n=5 Participants	45 participants n=7 Participants	91 participants n=5 Participants
Race/Ethnicity, Customized African American	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Multi-racial	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	48 participants n=5 Participants	47 participants n=7 Participants	95 participants n=5 Participants
Cancer Stage Stage 0	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Cancer Stage Stage I	21 participants n=5 Participants	15 participants n=7 Participants	36 participants n=5 Participants
Cancer Stage Stage II	15 participants n=5 Participants	22 participants n=7 Participants	37 participants n=5 Participants
Cancer Stage Stage III	6 participants n=5 Participants	4 participants n=7 Participants	10 participants n=5 Participants
Smoking Status Missing	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Smoking Status Current Smoker	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Smoking Status Non-Smoker	25 participants n=5 Participants	22 participants n=7 Participants	47 participants n=5 Participants
Smoking Status Former Smoker	22 participants n=5 Participants	23 participants n=7 Participants	45 participants n=5 Participants
Body Mass Index (BMI)	25.7 Kg/m2 n=5 Participants	25.0 Kg/m2 n=7 Participants	25.6 Kg/m2 n=5 Participants
Estradiol	4.59 pg/ml STANDARD_DEVIATION 4.03 • n=5 Participants	3.35 pg/ml STANDARD_DEVIATION 2.19 • n=7 Participants	3.97 pg/ml STANDARD_DEVIATION 3.29 • n=5 Participants
Insulin-like Growth Factor 1	181.95 ng/ml STANDARD_DEVIATION 60.22 • n=5 Participants	177.83 ng/ml STANDARD_DEVIATION 46.67 • n=7 Participants	179.89 ng/ml STANDARD_DEVIATION 53.6 • n=5 Participants
Sleep (Pittsburgh Sleep Quality Index)	7.2 units on a scale STANDARD_DEVIATION 4.2 • n=5 Participants	5.5 units on a scale STANDARD_DEVIATION 3.3 • n=7 Participants	6.4 units on a scale STANDARD_DEVIATION 3.9 • n=5 Participants
Hot Flashes	5.5 hot flash score STANDARD_DEVIATION 6.5 • n=5 Participants	4.5 hot flash score STANDARD_DEVIATION 5.2 • n=7 Participants	5.1 hot flash score STANDARD_DEVIATION 5.9 • n=5 Participants
Mood	6.7 CESD global score STANDARD_DEVIATION 5.5 • n=5 Participants	6.0 CESD global score STANDARD_DEVIATION 6.3 • n=7 Participants	6.3 CESD global score STANDARD_DEVIATION 5.9 • n=5 Participants

PRIMARY outcome

Timeframe: 4 months

Absolute plasma estradiol levels after 4 month course of melatonin or placebo, only 4 month level provided below.

Outcome measures

Measure	Melatonin n=43 Participants Taken orally, once per day, at/around 9:00pm Melatonin	Placebo n=43 Participants Taken orally, once per day, at/around 9:00pm Placebo
Absolute Plasma Estradiol Levels After 4 Month Course of Melatonin or Placebo	4.59 pg/ml Standard Deviation 3.42	3.39 pg/ml Standard Deviation 2.25

PRIMARY outcome

Timeframe: 4 months

To evaluate compliance with a 4 month course of melatonin. Compliance was assessed via pill counts.

Outcome measures

Measure	Melatonin n=48 Participants Taken orally, once per day, at/around 9:00pm Melatonin	Placebo n=47 Participants Taken orally, once per day, at/around 9:00pm Placebo
Compliance	43 participants	43 participants

SECONDARY outcome

Timeframe: baseline and 4 months

Mood was assessed by the Center for Epidemiologic studies Depression Scale. The scale measures depressive symptoms in 20 items. Each question has a 4 point answer (0-3) so the scale range is 0-60. A higher score indicates more depression. Sleep quality was assessed by the Pittsburgh Sleep Quality Index. There are 19 questions each with a 3 point answer. The questions are grouped into 7 subscales and each has a value from 0-3. The 7 subscales are then added together to yield a global score with a range of 0-21. Higher scores indicate worse sleep. Menopausal symptoms were assessed by NCCTG Hot Flash diary. Subjects track the number and severity of hot flashes daily for 1 week. Subjects grade the severity of the hot flashes on a scale of 1-4, with 1 being mild and 4 very severe. Frequency and the severity determine the score . The minimum score is 0 (no hot flashes) and there is no maximum score. A higher score indicates more severe hot flashes. There are no subscales or no units.

Outcome measures

Measure	Melatonin n=43 Participants Taken orally, once per day, at/around 9:00pm Melatonin	Placebo n=43 Participants Taken orally, once per day, at/around 9:00pm Placebo
Change in Mood, Sleep Quality and Menopausal Symptoms From Baseline to 4 Months Change in PSQI	-1.9 change in PSQI score Standard Deviation 2.4	-0.1 change in PSQI score Standard Deviation 2.0
Change in Mood, Sleep Quality and Menopausal Symptoms From Baseline to 4 Months Change in CESD	-0.2 change in PSQI score Standard Deviation 4.6	-0.0 change in PSQI score Standard Deviation 5.4
Change in Mood, Sleep Quality and Menopausal Symptoms From Baseline to 4 Months Change in Hot Flash Score	-1.0 change in PSQI score Standard Deviation 6.1	-1.3 change in PSQI score Standard Deviation 3.9

Adverse Events

Melatonin

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Melatonin n=48 participants at risk Taken orally, once per day, at/around 9:00pm Melatonin	Placebo n=47 participants at risk Taken orally, once per day, at/around 9:00pm Placebo
Nervous system disorders Headache	6.2% 3/48 • During 4 months of study treatment	0.00% 0/47 • During 4 months of study treatment
General disorders Bad Dreams	8.3% 4/48 • During 4 months of study treatment	2.1% 1/47 • During 4 months of study treatment

Additional Information

Dr. Wendy Chen

DFCI

Phone: 617-632-3800

Email: wychen@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place