Cancer-related insomnia
Conditions
Interventions
waitlist control group:Standard Care
Governor Vessel Moxibustion Group:Standard Care + Governor Vessel Moxibustion
Sponsors
Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age between 18 and 75 years; 2) Female patients diagnosed with stage I-III breast cancer; 3) Completion of primary breast cancer treatment (surgery radiotherapy chemotherapy targeted therapy immunotherapy) for at least 3 months with ongoing endocrine therapy permitted if duration exceeds 3 weeks; 4) No evidence of cancer recurrence or new primary tumors; 5) Meets the diagnostic criteria for insomnia as defined in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) published by the American Psychiatric Association (APA); 6) Mild to severe insomnia defined by an Insomnia Severity Index (ISI) score ranging from 8 to 21.
Exclusion criteria
Exclusion criteria: 1) Presence of other sleep disorders (e.g. obstructive sleep apnea parasomnias narcolepsy); 2) Shift work or Irregular sleep habits; 3) Presence of severe medical conditions or health issues that could impede full participation in the study; 4) Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| serum inflammatory cytokines (interleukin-1ß interleukin-6 and tumor necrosis factor-a);gut microbiota;serum melatonin levels;serum hormones related to the hypothalamic-pituitary-adrenal (HPA) axis [adrenocorticotropic hormone (ACTH) corticotropin-releasing hormone (CRH) and cortisol (CORT);cores on the Functional Assessment of Cancer Therapy-Breast (FACT-B) scale;usage of hypnotic medications;serum neurotransmitters (5-hydroxytryptamine and gamma-aminobutyric acid);fecal short-chain fatty acids;serum metabolites; | — |
Countries
China
Contacts
Public ContactBing Lin
Health Management Center Hospital of Chengdu University of Traditional Chinese Medicine
Outcome results
None listed