Clinical trial NCT00690196: Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanisms
Official title: Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanism
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep Disorders
Sleep Initiation and Maintenance Disorders
Dyssomnias
Mental Disorders
Nervous System Diseases
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2008-06-04
Enrollment: 90
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Breast Cancer is the most common cancer in women. After completion of successful therapy, may behavioral symptoms persist with over 20% of breast cancer survivors reporting chronic insomnia of greater than 6 months duration that fulfils clinical diagnostic criteria with associated functional limitations, decreased quality of life, and possible effects on long-term survival. Behavioral interventions are highly efficacious in the treatment of insomnia and preferred over hypnotic medication when insomnia is chronic. However, insomnia studies conducted in cancer are scarce. The proposed research builds upon program of study that has examined the efficacy of mind-body intervention, Tai Chi Chih (TCC), on health outcomes including sleep impairments. Preliminary studies show that TTC, a slow moving meditation, contributes to improvement in subjective sleep quality, sleep amounts and sleep efficiency. The investigators have further found that sleep, fatigue and proinflammatory cytokine activity are reciprocally related and that TCC decreases the mechanism through TCC carries its effects on sleep outcomes.

Detailed description: 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.

Eligibility criteria: 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 examination;
* Smokers will also be excluded because of potential confounding effects on markers of inflammation;
* 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.

Primary outcomes:
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
timeFrame: 5 years
Secondary outcomes:
measure: Overall Health and Well-being
timeFrame: 5 years
measure: Allostatic Load
timeFrame: 5 years
measure: Inflammatory Markers
timeFrame: 5 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Cousins Center for Psychoneuroimmunology
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Michael Irwin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Irwin MR, Olmstead R, Oxman MN. Augmenting immune responses to varicella zoster virus in older adults: a randomized, controlled trial of Tai Chi. J Am Geriatr Soc. 2007 Apr;55(4):511-7. doi: 10.1111/j.1532-5415.2007.01109.x.
citation: Bower JE, Ganz PA, Aziz N, Olmstead R, Irwin MR, Cole SW. Inflammatory responses to psychological stress in fatigued breast cancer survivors: relationship to glucocorticoids. Brain Behav Immun. 2007 Mar;21(3):251-8. doi: 10.1016/j.bbi.2006.08.001. Epub 2006 Sep 27.
citation: Motivala SJ, Sarfatti A, Olmos L, Irwin MR. Inflammatory markers and sleep disturbance in major depression. Psychosom Med. 2005 Mar-Apr;67(2):187-94. doi: 10.1097/01.psy.0000149259.72488.09.
citation: Irwin MR, Pike JL, Cole JC, Oxman MN. Effects of a behavioral intervention, Tai Chi Chih, on varicella-zoster virus specific immunity and health functioning in older adults. Psychosom Med. 2003 Sep-Oct;65(5):824-30. doi: 10.1097/01.psy.0000088591.86103.8f.