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Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanism

30 Years
70 Years
Not Enrolling
Sleep Disorders, Sleep Initiation and Maintenance Disorders, Dyssomnias, Mental Disorders, Nervous System Diseases

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Trial Information

Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanism

This investigation is a randomized controlled trial that will evaluate the effects of
cognitive-behavioral therapy (CBT) and Tai Chi Chih (TCC) on objective and subjective
measures of sleep, on mood and fatigue, on health functioning and on two biological
parameters, sympathovagal tone and proinflammatory cytokine activity in older adults with
insomnia. One hundred breast cancer survivors will be randomly assigned to CBT, or TCC.
Patients will be assessed at pre-treatment, during midtreatment, post-treatment, 3-month
follow-up and 12-month follow-up. At all 5 assessment periods, indices of sleep quality as
measured by sleep diaries and clinical ratings will be obtained along with measures of mood,
health functioning, proinflammatory cytokine activity and heart rate variability (HRV). The
pre-treatment and post-treatment assessment periods will also include all-night
polysomnography along with nocturnal sampling of proinflammatory cytokine activity and HRV
tone. Hence, polysomnographic measures of sleep which are coupled with nocturnal measures
of cytokines by serial blood sampling will occur at the baseline assessment and again at the
post-treatment assessment. During midtreatment and at 3 month follow-up and 12 month
follow-up, we will obtain questionnaire ratings of sleep quality along with a single morning
sample of cytokine levels.

Inclusion Criteria:

- 100 postmen women between the ages of 30 - 70 years who were originally diagnosed
with early, resectable breast cancer (Stage 0, I, or II, III), have completed
treatment with surgery, radiation, and/or chemotherapy, and show no evidence of
cancer recurrence or new primary tumor.

- Difficulty sleeping for a minimum of 3 nights per week

- Insomnia duration at least 6 months

- Complaint of at least 1 negative effect during waking hours (e.g. fatigue, impaired
functioning, mood disturbances) attributed to insomnia

- Habitual sleep-wake schedule reporting "lights-out" between 9:00 PM-midnight

- Accessible geographically

Exclusion Criteria:

- Evidence that insomnia is directly related to a medical disorder (e.g.,
hyperthyroidism) or effects of a medication that affects sleep structure and/or
immune functioning

- Presence of sleep apnea (apnea-hypopnea index >15) or periodic limb movements during
sleep (myoclonic index with arousal >15) as assessed by PSG;

- Presence of another sleep disorder (e.g., Advanced or Delay Sleep Phase Syndrome)

- Current or History of another major psychiatric disorder

- Cognitive impairment as suggested by a score lower than 23 on the Mini-Mental State

- Smokers will also be excluded because of potential confounding effects on markers of

- Body mass index that is greater than 35 kg/m2, obesity is associated with excessive
levels of inflammatory markers

- Unable to commit to intervention schedule.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Changes in insomnia symptoms as measured by subjective report and objective polysomnography; Changes in daytime impairment secondary to insomnia; Changes in fatigue, depression and mood, and health function

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Michael Irwin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Los Angeles


United States: Institutional Review Board

Study ID:

R01 CA119 159



Start Date:

March 2008

Completion Date:

July 2012

Related Keywords:

  • Sleep Disorders
  • Sleep Initiation and Maintenance Disorders
  • Dyssomnias
  • Mental Disorders
  • Nervous System Diseases
  • Mental Disorders
  • Psychotic Disorders
  • Breast Neoplasms
  • Sleep Initiation and Maintenance Disorders
  • Nervous System Diseases
  • Sleep Disorders
  • Parasomnias
  • Dyssomnias



UCLA Cousins Center for PsychoneuroimmunologyLos Angeles, California  91744