Cancer
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Meet the fifth edition of the Diagnostic Criteria for Mental Disorders and the defined diagnostic criteria for advanced cancer (2) Age 18-75 years; (3) Eastern Cooperative Oncology Group (ECOG) physical status = 2 points; (4) Sleep Severity Index Scale (ISI) score = 8. (5) Expected survival time = 6 months based on PaP score activity status = 60 points combined with clinician judgment; and (6) Currently expect to receive or are receiving systemic palliative systemic anticancer therapy including chemotherapy immunotherapy or combination therapy; (7) Previously expect to receive or are receiving systemic palliative systemic anticancer therapy including chemotherapy immunotherapy or combination therapy. (7) Have not received acupuncture treatment in the previous 6 months; and (8) be conscious have stable vital signs and have no obvious communication disorders to treat; and (9) Understanding of the trial and signing an informed consent form. (10) Subjects currently taking a stable dose of sedative-hypnotic medication were eligible for inclusion (stable dose was defined as no change in the type or dose of medication within 6 weeks prior to the start of the study)
Exclusion criteria
Exclusion criteria: (1) Uncorrectable diffuse intravascular coagulation or severe thrombocytopenia with bleeding tendency i.e. platelet count 1.5; hemoglobin =90 g/dL ;and (2) Surgical treatment conversion therapy radical radiotherapy and other patients receiving treatment aimed at eradication; (3) Contraindications to acupuncture such as ulcers abscesses and skin infections at the site of needling; and (4) Patients who have a combination of serious circulatory respiratory digestive urinary endocrine and hematopoietic systems and other primary diseases that cannot be controlled by conventional medication; and (5) Insomnia caused by cancer pain with Numerical Rating Scale (NRS) score =4 or insomnia caused by other somatic diseases; and (6) Treatment for insomnia other than hypnotic drugs in the last 3 months (7) have participated in other clinical medical trial studies in the last 3 months; and (8) Patients with a history of mental illness or being treated for mental disorders; and (9) Patients with brain tumors or with extensive metastases to the brain; (10) Pregnant or lactating women; and (11) Other types of sleep disorders: restless legs syndrome sleep-wake disorders. claustrophobia or other contraindications to functional magnetic resonance; and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 items;Single Patient Overall Impression - Insomnia Severity;Edmonton symptom assessment scale;Pittsburgh Sleep Index; | — |
Countries
China
Contacts
Shenzhen Hospital (Fu Tian) of Guangzhou University of Chinese Medicine