breast caner related insomnia
Conditions
Interventions
Acupuncture group:Acupuncture treatment
Health control group:None
Sponsors
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Brest cancer related insomnia(CRI) patient 1.Meet the diagnosis of stage I to III breast cancer; Meet the DSM-IV diagnostic criteria for insomnia, the symptoms of which occurred after breast cancer diagnosis and lasted for at least 1 month. 2.Age from 18 to 75 years, female. 3.Eastern Cooperative Oncology Group performance status score = 8. 5.Survival prediction >= 6 months. 6.No acupuncture treatment has been carried out. 7.Right-handed. 8.No MRI contraindications such as MR-incompatible metal implants or claustrophobia. 9.Consent to participate and provide written informed consent. Healthy subjects 1.Age-, hand dominance-, and educational level-matched to the selected breast CRI patients. 2.Self-reported good sleep quality with ISI score<8. 3.Without previous functional or organic disease or history of head trauma. 4.No MRI contraindications as for the CRI patients. 5.Consent to participate and provide written informed consent.
Exclusion criteria
Exclusion criteria: Brest cancer related insomnia patient 1. Insomnia associated with caner pain (NRS>= 4) or other physical and mental illness. 2. Irregular sleep habits or night shift. 3. History of drug abuse or addiction. 4. Patients who took sedative or hypnotic drugs within recent 2 weeks, or accepted other treatment for insomnia within recent 3 months, or participated in other clinical trials within the last month. 5. There will be radiotherapy, chemotherapy or surgery plan during the trail. 6. Concomitant serious heart, liver, kidney, and other major diseases. 7. Pregnant or nursing. 8. Inability to understand and complete the scale. 9. Ulcers, abscesses, infections at the needling site. Healthy subjects 1. Pregnant or nursing. 2. Irregular sleep habits or night shift.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment response rate of Insomnia Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of Insomnia Severity Index (ISI);Treatment remission rate of Insomnia Severity Index;Actigraphy sleep assessment;Generalized Anxiety Disorder Scale (GAD-7);Patient Health Questionnaire-9 (PHQ-9);Quality of Life Core Scale (QLQ-C30);Usage of remedial drugs;Masking assessment;Incidence of adverse events;Resting-state functional MRI; | — |
Countries
China
Contacts
Public ContactYuelai Chen
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed