Melatonin Postoperative Sleep Study in Breast Cancer Patients

This study has been terminated.
(Terminated due to low accrual.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00506064
First received: July 23, 2007
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

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).


Condition Intervention Phase
Breast Cancer
Drug: Melatonin
Drug: Placebo
Behavioral: Questionnaire
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Melatonin Postoperative Sleep Study in Breast Cancer Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Objective responses measured by wrist actigraph (measures sleep movement), and the Sp02 monitor (measures the % oxy-hemoglobin in the blood)


Enrollment: 4
Study Start Date: February 2004
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Melatonin
0.15 mg/kg capsules by mouth daily
Drug: Melatonin
0.15 mg/kg by mouth (PO) Daily
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
Placebo Comparator: Placebo
Starch capsules by mouth 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

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. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00506064     History of Changes
Other Study ID Numbers: DM02-563
Study First Received: July 23, 2007
Results First Received: March 29, 2010
Last Updated: December 3, 2012
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

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

ClinicalTrials.gov processed this record on September 14, 2014