Trial Outcomes & Findings for Melatonin Versus Placebo and the Effect on Appetite in Advanced Cancer Patients (NCT NCT00513357)
NCT ID: NCT00513357
Last Updated: 2012-12-11
Results Overview
Difference in ESAS (Edmonton Symptom Assessment Scale) assessment scores of appetite (symptom) from baseline evaluation \[± 3 days\] to 4 week evaluation \[± 3 days\], where the severity at the time of assessment is rated from 0 to 10 on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
82 participants
Primary outcome timeframe
Baseline and at 4 weeks
Results posted on
2012-12-11
Participant Flow
Recruitment Period: 07/21/2006 -04/08/2011. All participants recruited at UT MD Anderson Cancer Center.
Of the 125 participants, there were 52 participants excluded (43 did not meet inclusion criteria; and 9 declined to participate).
Participant milestones
| Measure |
Melatonin
20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
|
Placebo
20 mg of placebo before going to sleep at night for a period of 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
35
|
|
Overall Study
COMPLETED
|
23
|
25
|
|
Overall Study
NOT COMPLETED
|
15
|
10
|
Reasons for withdrawal
| Measure |
Melatonin
20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
|
Placebo
20 mg of placebo before going to sleep at night for a period of 4 weeks.
|
|---|---|---|
|
Overall Study
did not receive allocated placebo
|
2
|
3
|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
|
Overall Study
Disease Progression
|
2
|
1
|
Baseline Characteristics
Melatonin Versus Placebo and the Effect on Appetite in Advanced Cancer Patients
Baseline characteristics by cohort
| Measure |
Melatonin
n=38 Participants
20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
|
Placebo
n=35 Participants
20 mg of placebo before going to sleep at night for a period of 4 weeks.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
Age range
|
59 years
n=5 Participants
|
62 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
35 participants
n=7 Participants
|
73 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and at 4 weeksDifference in ESAS (Edmonton Symptom Assessment Scale) assessment scores of appetite (symptom) from baseline evaluation \[± 3 days\] to 4 week evaluation \[± 3 days\], where the severity at the time of assessment is rated from 0 to 10 on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity.
Outcome measures
| Measure |
Melatonin
n=23 Participants
20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
|
Placebo
n=25 Participants
20 mg of placebo before going to sleep at night for a period of 4 weeks.
|
|---|---|---|
|
Change in Appetite as Measured by ESAS
|
-0.83 units on a scale
Standard Deviation 2.6 • Interval 6.0 to 8.0
|
-1.19 units on a scale
Standard Deviation 2.3 • Interval 4.0 to 9.0
|
Adverse Events
Melatonin
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Melatonin
n=38 participants at risk
20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
|
Placebo
n=35 participants at risk
20 mg of placebo before going to sleep at night for a period of 4 weeks.
|
|---|---|---|
|
Psychiatric disorders
Confusion
|
0.00%
0/38 • 4 years and 2 months
|
2.9%
1/35 • Number of events 1 • 4 years and 2 months
|
|
General disorders
Death
|
5.3%
2/38 • Number of events 2 • 4 years and 2 months
|
0.00%
0/35 • 4 years and 2 months
|
|
Investigations
Alkaline Phosphatase
|
0.00%
0/38 • 4 years and 2 months
|
2.9%
1/35 • Number of events 1 • 4 years and 2 months
|
|
Investigations
AST, SGOT
|
0.00%
0/38 • 4 years and 2 months
|
2.9%
1/35 • Number of events 1 • 4 years and 2 months
|
Other adverse events
| Measure |
Melatonin
n=38 participants at risk
20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
|
Placebo
n=35 participants at risk
20 mg of placebo before going to sleep at night for a period of 4 weeks.
|
|---|---|---|
|
Psychiatric disorders
Confusion
|
2.6%
1/38 • Number of events 1 • 4 years and 2 months
|
0.00%
0/34 • 4 years and 2 months
|
|
General disorders
Fatigue
|
2.6%
1/38 • Number of events 1 • 4 years and 2 months
|
11.8%
4/34 • Number of events 4 • 4 years and 2 months
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/38 • Number of events 1 • 4 years and 2 months
|
5.9%
2/34 • Number of events 2 • 4 years and 2 months
|
|
General disorders
Pain
|
2.6%
1/38 • Number of events 1 • 4 years and 2 months
|
0.00%
0/34 • 4 years and 2 months
|
|
Nervous system disorders
Somnolence
|
2.6%
1/38 • Number of events 1 • 4 years and 2 months
|
2.9%
1/34 • Number of events 1 • 4 years and 2 months
|
|
Gastrointestinal disorders
Constipation
|
2.6%
1/38 • Number of events 1 • 4 years and 2 months
|
0.00%
0/34 • 4 years and 2 months
|
|
General disorders
Constitutional Symptom (other)
|
0.00%
0/38 • 4 years and 2 months
|
2.9%
1/34 • Number of events 1 • 4 years and 2 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/38 • 4 years and 2 months
|
2.9%
1/34 • Number of events 1 • 4 years and 2 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/38 • 4 years and 2 months
|
2.9%
1/34 • Number of events 1 • 4 years and 2 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/38 • 4 years and 2 months
|
2.9%
1/34 • Number of events 1 • 4 years and 2 months
|
|
Nervous system disorders
Syncope (Fainting)
|
0.00%
0/38 • 4 years and 2 months
|
2.9%
1/34 • Number of events 1 • 4 years and 2 months
|
Additional Information
Dr. Egidio Del Fabbro
University of Texas MD Anderson Cancer Center
Phone: 713-563-4157
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place