endocrine therapy-associated insomnia in breast cancer
Conditions
Interventions
group 1:auricular acupuncture combined with percutaneous auricular electrical stimulation +psychological intervention
group 2:sham acupuncture+psychological intervention
Sponsors
Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Female, aged = 18 years and = 80 years; (2) Histopathologically diagnosed as stage I-III estrogen receptor (ER) - positive breast cancer and / or progesterone receptor (PR) - positive breast cancer, according to the Chinese society of clinical oncology breast cancer (CSCO BC) diagnosis and treatment guidelines (2022 version); (3) Currently receiving oral endocrine therapy drugs with a history of = 1 month, and plans to continue to receive endocrine therapy during the study period; (4) Meet the diagnostic criteria of breast cancer and insomnia; (5) The total score of Pittsburgh sleep quality index (PSQI) was > 7; (6) According to the Eastern Cooperative Oncology Group (ECoG) activity status score table, patients with a score of 0 or 1 ("0" stands for completely normal activity ability, without any difference from the activity ability before the onset; "1" stands for free walking and engaging in light physical activities, including general household or office work, but can not engage in heavy physical activities), their survival is predicted to be = 3 months; (7) Taking sedative hypnotic drugs stably for more than 1 month or not before entering this study; (8) Follow the principle of voluntariness, and sign the informed consent before entering the study.
Exclusion criteria
Exclusion criteria: (1) Patients who are currently receiving chemotherapy or radiotherapy or who have surgery plans during the protocol; (2) Patients with severe heart, liver and kidney function injury, respiratory, blood and mental system or combined with other tumor diseases; (3) Any current or past serious cardiovascular disease, or people who are not suitable for acupuncture treatment, such as: face or ear pain, ear trauma, metal implantation higher than the neck level, serious skin disease, allergic constitution; (4) Suffering from other sleep disorders: related to breathing, such as obstructive sleep apnea syndrome or restless legs syndrome of lower limbs, etc.: (5) Participated in other clinical research topics in the last 3 months. (6) She received acupuncture treatment for insomnia symptoms 1 month before the start of the study. (7) Ear diseases such as ulcers, abscesses, etc. cannot be carried out by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index scale (ISI);actigraph;Heart rate variability (HRV);Beck Anxiety Inventory (BAI);Beck Depression Inventory (BDI);Functional Assessment of Cancer Therapy (FACT);Functional Assessment of Cancer Therapy-Endocrine Symptom (FACT-ES);Epworth Sleepiness Scale (ESS);Credibility and expectancy;Sex Hormones;Inflammatory factors;Survival follow-up;Dosage taken during the study period; | — |
Countries
China
Contacts
Public ContactJi Yajie
Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed