Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00506064
Status:
TERMINATED
Last Update Posted:
2012-12-05
First Post:
2007-07-23
Brief Title:
Melatonin Postoperative Sleep Study in Breast Cancer Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Melatonin Postoperative Sleep Study in Breast Cancer Patients
Status:
TERMINATED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective
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 patients sleep in a scaled score out of 100 with 100 being the highest degree of satisfaction
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 patients sleep in a scaled score out of 100 with 100 being the highest degree of satisfaction
Detailed Description:
Melatonin is produced by a small gland in the brain called the pineal gland During times of stress use of certain medications and increasing age melatonin production may be disrupted or weakened This may cause sleep disturbance Many of the drugs used for pain anesthesia or cancer treatment may affect the bodys natural secretion of melatonin
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 1000PM 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 handfinger 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 nights 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
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 1000PM 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 handfinger 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 nights 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None