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Melatonin Postoperative Sleep Study in Breast Cancer Patients
This study is ongoing, but not recruiting participants.
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00506064
  Purpose

Primary Objective:

1. 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:

1. 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).


Condition Intervention Phase
Breast Cancer
Drug: Melatonin
Drug: Placebo
Behavioral: Questionnaire
Phase I

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Anesthesia Breast Cancer Cancer
Drug Information available for: Starch Melatonin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Melatonin Postoperative Sleep Study in Breast Cancer Patients

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To see if giving melatonin (for one week) to patients after surgery improves the patient's sense of well-being during the day, the patient's energy level, the patient's overall night sleep. These three things make up sleep architecture. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To find out if the melatonin decreases the occurrence of possible heart or lung complications after surgery in patients receiving cancer related surgery and general anesthesia. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • To collect data to validate a new sleep questionnaire: the Postoperative Srejic Sleep SAT Survey. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2004
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Melatonin
Drug: Melatonin
0.15 mg/kg PO Daily
Behavioral: Questionnaire
Sleep study surveys, two per day completed each evening, lasting 10 minutes
2: Placebo Comparator
Placebo
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

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 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. ASA 1-4 levels
  4. Willing and able to give written informed consent
  5. Willing and able to complete questionnaires in Appendices B-E
  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 BUN or Cr >2.5X ULN; Bili or AST or ALT>2.5X 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00506064

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Una Srejic, MD U.T.M.D. Anderson Cancer Center
  More Information

The University of Texas M.D.Anderson Cancer Center  This link exits the ClinicalTrials.gov site

Responsible Party: U.T.M.D. Anderson Cancer Center ( Una Srejic, MD/Clinical Assistant Professor )
Study ID Numbers: DM02-563
Study First Received: July 23, 2007
Last Updated: October 6, 2008
ClinicalTrials.gov Identifier: NCT00506064  
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Sleep
Melatonin
Placebo
Survey
Postoperative Srejic Sleep SAT Survey

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Melatonin
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Antioxidants
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Protective Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009