A Randomized Clinical Trial of Melatonin Versus Placebo and the Effect on Appetite in Advanced Cancer Patients
18 Years
N/A
Both
Gastrointestinal Cancer, Lung Cancer
Trial Information
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
hours.
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
months.
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
repeated.
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.
Inclusion Criteria:
1. Patients with solid gastrointestinal tumors or lung cancer patients referred to
palliative care and a 5% or more involuntary weight loss within the last 6 months
with anorexia (>3 on visual analog scale such as ESAS)
2. Greater than or equal to 18 years of age
3. Karnofsky score of 40 or higher
4. Patient has the ability to maintain oral food intake during the study period
5. If patients who have persistent anorexia/cachexia and are currently taking Megace,
corticosteroids, non-steroidal anti-inflammatories (NSAID's), or thalidomide, they
should be on the medication at least 2 weeks prior to study inclusion
6. Ability to sign informed consent and understand study procedures
7. Patient can continue all medications including complementary therapies or
antineoplastic therapy while on-study other than melatonin if they have been on
stable dose for at least 2 weeks
8. Negative pregnancy testing in women with child bearing potential defined as not
post-menopausal for 12 months or no previous surgical sterilization.
9. Patients who cannot take Megace because of past history or elevated risk of DVT,
adrenal insufficiency, impotence, hyperglycemia, CHF, menorrhagia, etc.
10. Patients who have persistent anorexia/cachexia after treatment with Megace has failed
Exclusion Criteria:
1. Patients who have dementia or delirium on entry into study as determined by the
palliative care specialist using DSM-IV-criteria
2. Patients who are currently taking melatonin
3. Inability to take oral food during the study period
4. Unstable secondary cachexia caused by nausea, diarrhea, taste abnormalities,
mucositis, constipation, dysphagia, or clinical depression prior to study inclusion.
These symptoms should be resolved or stable for >/= 2 weeks at the time of inclusion
into study as determined by the Palliative Care Specialist.
5. Inability to sign informed consent or understand study procedures
6. Karnofsky score of < 40
7. Patients < 18 years of age
8. Patients with < 3 on ESAS
9. Patients who are on complementary therapies containing melatonin or on medications
for < 2 weeks and not on stable dose
10. Patients who have a cortisol level of unless they are on replacement corticosteroids.
11. Patients with a TSH of /= 10 mcL/mL at baseline will be excluded
12. Pregnant females or females who are lactating/nursing
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Change in Appetite as Measured by ESAS
Outcome Description:
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.
Outcome Time Frame:
Baseline and at 4 weeks
Safety Issue:
No
Principal Investigator
Rony Dev, DO
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2005-0901
NCT ID:
NCT00513357
Start Date:
June 2006
Completion Date:
December 2012
Related Keywords:
- Gastrointestinal Cancer
- Lung Cancer
- Gastrointestinal Cancer
- Lung Cancer
- Cachexia
- Melatonin
- Placebo
- Anorexia
- Weight Loss
- Lung Neoplasms
- Gastrointestinal Neoplasms
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
| Joan Karnell Cancer Center | Philadelphia, Pennsylvania 19107 |
