Melatonin Postoperative Sleep Study in Breast Cancer Patients
NCT ID: NCT00506064
Last Updated: 2012-12-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
4 participants
INTERVENTIONAL
2004-02-29
2008-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
To evaluate the impact of postoperative exogenous nocturnal melatonin supplementation on the early regulation of the sleep-wake cycle and its clinical impact (subjective improvement of the quality of sleep and reduction of cardiopulmonary events) during the first postoperative week following anesthesia and surgery in older breast cancer patients receiving a unilateral segmental mastectomy with or without intraoperative lymph node mapping, sentinel node biopsy and axillary node dissection.
Secondary Objective:
To collect data and validate the Postoperative Srejic Sleep SAT Survey Questionnaire (SAT implies relative subjective satisfaction of the patient's sleep in a scaled score out of 100 with 100 being the highest degree of satisfaction).
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants in this study will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Participants in one group will receive melatonin. Participants in the other group will receive a placebo. A placebo is a substance that looks like the study drug, but which has no active ingredients. There is an equal chance of being in either group. Neither you nor the study doctor will know to which group you are assigned. You will take either two, three, or four capsules 30 minutes before you go to bed. You will go to bed at about the same time each day (around 10:00PM). The number of capsules will be prescribed according to your body weight.
Researchers will attach two monitors to you while you are sleeping to test for changes during sleep. An actigraph wrist monitor will be worn on the non-dominant wrist (to measure sleep movement and patterns). A pulse oximeter will be worn on the opposite hand/finger (to measure the amount of oxygen in the blood). You may use these devices as an inpatient or outpatient at home.
Each day of the study (for one week after the operation and anesthesia) you will fill out 1-2 questionnaires depending on the day. The researchers will ask questions about your last night's sleep and how you are feeling. The questionnaires will be filled out each evening. This will take less than 10 minutes.
If on Day 4 you require any additional sleep medicine or have been experiencing any unpleasant side effects of melatonin, you may remove yourself from the study. The entire length of this study is made up of the one week after your surgery. Should you take any other sleep aids during the time of the study, please tell the research staff as your questionnaire data cannot then be used for this study.
You will visit your cancer doctor and the study doctor at least one time after your surgery. This follow-up visit will be coordinated with your surgical postoperative visit. Researchers may go over some parts of the questionnaires and retrieve the actigraph and pulse oximeter from you.
This is an investigational study. Melatonin has not gone through the FDA approval process. However, melatonin supplements are commercially available in over-the-counter form. Forty patients will take part in this study. All will be enrolled at UTMDACC.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Melatonin
0.15 mg/kg capsules by mouth daily
Melatonin
0.15 mg/kg by mouth (PO) Daily
Questionnaire
Sleep study surveys, two per day completed each evening, lasting 10 minutes
Placebo
Starch capsules by mouth daily
Placebo
Two, three, or four starch tablet or capsules before bed
Questionnaire
Sleep study surveys, two per day completed each evening, lasting 10 minutes
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Melatonin
0.15 mg/kg by mouth (PO) Daily
Placebo
Two, three, or four starch tablet or capsules before bed
Questionnaire
Sleep study surveys, two per day completed each evening, lasting 10 minutes
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Ages \>= 40 years
3. American Society of Anesthesiology (ASA) physical status classification of preoperative functioning) 1-4 levels are acceptable
4. Willing and able to give written informed consent
5. Willing and able to complete questionnaires
6. Not currently taking benzodiazepine medication for insomnia.
Exclusion Criteria
2. Alcoholics
3. Seizure disorder
4. Thyroid disease
5. Pregnant or lactating patients (effects not known in pregnancy)
6. Renal/hepatic failure (if ood urea nitrogen (BUN) or creatinine (Cr) \>2.5\* Upper limit of normal (ULN); Bili or aspartate aminotransferase (AST) or alanine aminotransferase (ALT)\>2.5\* ULN)
7. Dementia/poor compliance
8. Manic/psychotic patients
9. Children/adults under 40 yrs
10. Movement disorders (ex. restless leg syndrome)
11. Tremor disorder (ex. parkinsonism)
12. Chronic benzodiazepine use for sleep (\>4 times per week )
13. Designated preop medications including melatonin for sleep
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
M.D. Anderson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Una Srejic, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
The University of Texas M.D.Anderson Cancer Center
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DM02-563
Identifier Type: -
Identifier Source: org_study_id