A Randomized Clinical Trial of Melatonin Versus Placebo and the Effect on Appetite in Advanced Cancer Patients
Melatonin is a hormone that is made by the part of the brain called the pineal gland and may
help in letting your body know when it is time to go to sleep and when it is time to wake
up. The researchers feel melatonin might help to improve your appetite, improve your
overall sense of well-being, and maintain your current weight.
If you are found to be eligible to take part in this study, you will see a nutritionist at
the first (baseline) visit. The nutritionist will measure the amount of calories you
consume. You will be asked to report all food and drinks you have had in a 3-day period.
If you are unable to remember what you have eaten and drunk in the last 3 days, you will be
asked by the nutritionist to list all the food and drinks you have had within the last 24
Your arm muscle diameter and your skin fold below your shoulder blade will be measured on
the arm you don't normally use to write with. This is to determine your body fat, lean mass
and water content of your body.
Your resting energy expenditure will be measured. You will be asked to wear a breathing
mask and to blow into a tube. This will allow your breath to be analyzed, to measure how
many calories your body is using while you are at rest.
Blood (about 1-2 tablespoons) will be drawn for tests to make sure there are no other
treatable causes for your weight loss.
This blood test may not need to be repeated if you have had a blood test in the last 3
If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the toss of a coin) to one of 2 groups. Participants in Group 1 will take melatonin
daily before bedtime for 4 weeks. Patients in Group 2 will take a placebo daily before
bedtime for 4 weeks. A placebo is a substance that looks like the study drug but which has
no active ingredients. You will have an equal chance (50/50) of being placed in either
group. Neither you nor any of the medical staff or researchers on this study will know if
you are receiving the study drug or placebo.
On Week 2, you will return to the clinic and you will repeat all the tests done at the
baseline visit. If you are unable to return to M. D. Anderson to complete the evaluations
on Day 14 (± 2 days), the research nurse will contact you by telephone and ask you about any
side effects you are experiencing.
At Week 4, you will return to the clinic and all the tests done at baseline will be
At the end of 4 weeks, all study patients in both groups will be given the opportunity to
take melatonin before going to sleep at night for an additional 4 weeks. If you choose not
to continue on melatonin for an additional 4 weeks, you will be taken off study and blood
will be drawn for your end of study tests which include albumin, C-reactive protein (CRP),
thyroid stimulating hormone (TSH), vitamin B-12, and cortisol. These tests will require
about 1-2 tablespoons of blood to be drawn. If you choose to continue on melatonin for an
additional 4 weeks, you will be asked to return to the outpatient clinic at Week 6 to repeat
the tests done at baseline.
Your end of study tests will be done at the end of 8 weeks.
You will continue to visit the study doctor at the outpatient clinic as long he feels it is
necessary. At these visits, your height and weight will be recorded and you will be asked
what food and drinks you have had.
This is an investigational study. Melatonin is not currently approved by the FDA except to
treat blind people with no light perception for sleep disorders-and is considered a
food/nutritional supplement. Up to 126 patients will be enrolled at MD Anderson and at Duke
University Medical Center in Durham, North Carolina.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Change in Appetite as Measured by ESAS
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.
Baseline and at 4 weeks
Rony Dev, DO
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|
|Joan Karnell Cancer Center||Philadelphia, Pennsylvania 19107|