Melatonin Postoperative Sleep Study in Breast Cancer Patients

NCT00506064 | Terminated Phase 1 Results

• 1 other identifier: DM02-563
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Keywords

Breast Cancer; Sleep; Melatonin; Placebo; Survey; Postoperative Srejic Sleep SAT Survey

Outcome Measures

Primary Outcomes (1)

• 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)

  Longitudinal study with major responses measured on days 0 (day of operation) and days 1-6 post-operative

Study Arms (2)

Melatonin

EXPERIMENTAL

0.15 mg/kg capsules by mouth daily

Drug: Melatonin; Behavioral: Questionnaire

Placebo

PLACEBO COMPARATOR

Starch capsules by mouth daily

Drug: Placebo; Behavioral: Questionnaire

Interventions

Melatonin DRUG

0.15 mg/kg by mouth (PO) Daily

Melatonin

Placebo DRUG

Two, three, or four starch tablet or capsules before bed

Placebo

Questionnaire BEHAVIORAL

Sleep study surveys, two per day completed each evening, lasting 10 minutes

Also known as: Survey, Insomnia Syndrome Questionnaire, Postoperative Srejic Sleep SAT Survey Questionnaire

Melatonin; Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Melatonin; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Limitations and Caveats

Study terminated early due to low recruitment, no analysis done.

Results Point of Contact

• Title: Una Srejic, MD / Professor
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-792-6914

Study Officials

• Una Srejic, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2007
• First Posted: July 25, 2007
• Study Start: February 1, 2004
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 5, 2012
• Results First Posted: January 25, 2011

Record last verified: 2012-12

Locations

US (1)