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Melatonin Postoperative Sleep Study in Breast Cancer Patients

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Melatonin
Placebo
Questionnaire
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Sleep, Melatonin, Placebo, Survey, Postoperative Srejic Sleep SAT Survey

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • U.T.M.D. Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Melatonin

Placebo

Arm Description

0.15 mg/kg capsules by mouth daily

Starch capsules by mouth daily

Outcomes

Primary Outcome Measures

Objective Sleep Response of Patients
Objective responses measured by wrist actigraph (measures sleep movement), and the Sp02 monitor (measures the % oxy-hemoglobin in the blood)

Secondary Outcome Measures

Full Information

First Posted
July 23, 2007
Last Updated
December 3, 2012
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00506064
Brief Title
Melatonin Postoperative Sleep Study in Breast Cancer Patients
Official Title
Melatonin Postoperative Sleep Study in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to low accrual.
Study Start Date
February 2004 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 patient's 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Sleep, Melatonin, Placebo, Survey, Postoperative Srejic Sleep SAT Survey

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melatonin
Arm Type
Experimental
Arm Description
0.15 mg/kg capsules by mouth daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Starch capsules by mouth daily
Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention Description
0.15 mg/kg by mouth (PO) Daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two, three, or four starch tablet or capsules before bed
Intervention Type
Behavioral
Intervention Name(s)
Questionnaire
Other Intervention Name(s)
Survey, Insomnia Syndrome Questionnaire, Postoperative Srejic Sleep SAT Survey Questionnaire
Intervention Description
Sleep study surveys, two per day completed each evening, lasting 10 minutes
Primary Outcome Measure Information:
Title
Objective Sleep Response of Patients
Description
Objective responses measured by wrist actigraph (measures sleep movement), and the Sp02 monitor (measures the % oxy-hemoglobin in the blood)
Time Frame
Longitudinal study with major responses measured on days 0 (day of operation) and days 1-6 post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Breast cancer patients having a unilateral segmental mastectomy, with or without intraoperative lymph node mapping, sentinel node biopsy, and axillary node dissection Ages >= 40 years American Society of Anesthesiology (ASA) physical status classification of preoperative functioning) 1-4 levels are acceptable Willing and able to give written informed consent Willing and able to complete questionnaires Not currently taking benzodiazepine medication for insomnia. Exclusion Criteria: Autoimmune diseases: rheumatoid arthritis, systemic lupus, or other collagen vascular disease Alcoholics Seizure disorder Thyroid disease Pregnant or lactating patients (effects not known in pregnancy) 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) Dementia/poor compliance Manic/psychotic patients Children/adults under 40 yrs Movement disorders (ex. restless leg syndrome) Tremor disorder (ex. parkinsonism) Chronic benzodiazepine use for sleep (>4 times per week ) Designated preop medications including melatonin for sleep
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Una Srejic, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
U.T.M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
The University of Texas M.D.Anderson Cancer Center

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Melatonin Postoperative Sleep Study in Breast Cancer Patients

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