Skip to content

Acupuncture for advanced cancer-related insomnia: a pilot study of a randomized controlled trial

Acupuncture for advanced cancer-related insomnia: a pilot study of a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000199
Enrollment
Unknown
Registered
2025-01-28
Start date
2025-01-31
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Interventions

Sponsors

Department of Rehabilitation Guangzhou University of Traditional Chinese Medicine Shenzhen Hospital (Futian)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

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

MeasureTime frame
Insomnia Severity Index;

Secondary

MeasureTime 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

Public ContactShaoyang Cui

Shenzhen Hospital (Fu Tian) of Guangzhou University of Chinese Medicine

herb107@126.com15112491899

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026