Clinical trial · Interventional
Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanisms
Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanism
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dyssomnias | — | UNRESOLVED | — |
| Mental Disorders | — | UNRESOLVED | — |
| Nervous System Diseases | — | UNRESOLVED | — |
| Sleep Disorders | — | UNRESOLVED | — |
| Sleep Initiation and Maintenance Disorders | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | — | UNRESOLVED |
| Tai Chi Chih | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Tai Chi Chih
- interventionNames
- Behavioral: Tai Chi Chih
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Cognitive Behavioral Therapy
- interventionNames
- Behavioral: Cognitive Behavioral Therapy
Primary outcomes (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDIrwin 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. PMID 17397428
- BACKGROUNDBower 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. PMID 17008048
- BACKGROUNDMotivala 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. PMID 15784782
- BACKGROUNDIrwin 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. PMID 14508027
- DERIVEDCai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2. PMID 41170811