Efficacy and cerebral responses of acupuncture for Breast Cancer-related Insomnia

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: Acupuncture group:Acupuncture treatment;Sham acupuncture group:Sham acupuncture treatment;Health control group:None; CONDITION: breast caner related insomnia PRIMARY OUTCOME: Treatment response rate of Insomnia Severity Index; SECONDARY OUTCOME: Changes of Insomnia Severity Inde X(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; 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 <= 2. 4.Sleep severity inde Xscale (ISI) 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.Cons
Epistemonikos ID: c34ee7ae2d0a50b1a6653b0bab76908e0670b8c1
First added on: Feb 20, 2024