Melatonin Postoperative Sleep Study in Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00506064
Recruitment Status : Terminated (Terminated due to low accrual.)
First Posted : July 25, 2007
Results First Posted : January 25, 2011
Last Update Posted : December 5, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

July 23, 2007
July 25, 2007
March 29, 2010
January 25, 2011
December 5, 2012
February 2004
September 2008   (Final data collection date for primary outcome measure)
Objective Sleep Response of Patients [ Time Frame: Longitudinal study with major responses measured on days 0 (day of operation) and days 1-6 post-operative ]
Objective responses measured by wrist actigraph (measures sleep movement), and the Sp02 monitor (measures the % oxy-hemoglobin in the blood)
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Complete list of historical versions of study NCT00506064 on Archive Site
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Melatonin Postoperative Sleep Study in Breast Cancer Patients
Melatonin Postoperative Sleep Study in Breast Cancer Patients

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 patient's sleep in a scaled score out of 100 with 100 being the highest degree of satisfaction).

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 body's 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 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.

Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Breast Cancer
  • Drug: Melatonin
    0.15 mg/kg by mouth (PO) Daily
  • Drug: Placebo
    Two, three, or four starch tablet or capsules before bed
  • Behavioral: Questionnaire
    Sleep study surveys, two per day completed each evening, lasting 10 minutes
    Other Names:
    • Survey
    • Insomnia Syndrome Questionnaire
    • Postoperative Srejic Sleep SAT Survey Questionnaire
  • Experimental: Melatonin
    0.15 mg/kg capsules by mouth daily
    • Drug: Melatonin
    • Behavioral: Questionnaire
  • Placebo Comparator: Placebo
    Starch capsules by mouth daily
    • Drug: Placebo
    • Behavioral: Questionnaire
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2008
September 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Breast cancer patients having a unilateral segmental mastectomy, with or without intraoperative lymph node mapping, sentinel node biopsy, and axillary node dissection
  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:

  1. Autoimmune diseases: rheumatoid arthritis, systemic lupus, or other collagen vascular disease
  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
Sexes Eligible for Study: All
40 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
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Principal Investigator: Una Srejic, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP