Electroacupuncture for treating insomnia in cancer patients: a clinical trial

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 45

Inclusion Criteria

1. Both male and female, aged 19 or over, but under 80 years
2. The Eastern Cooperative Oncology Group (ECOG) performance status = 2
3. Cessation of cancer-related treatments (e.g. surgery, radiotherapy, chemotherapy, immunotherapy) at least 12 weeks before the trial (except for on-going hormone therapy, which must have been initiated at least 3 weeks prior to enrollment)
4. Continuous insomnia related to cancer treatment or cancer itself for at least 3 months, fulfilment of The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for insomnia disorder
5. Total score in the Insomnia Severity Index (ISI) = 15 points
6. Willingness to participate in the trial and provide written consent

Exclusion Criteria

1. Current level of sleep disorder even before the diagnosis of cancer
2. Severe anemia (platelet count < 60,000/µL, or hemoglobin < 8 g/dL, or absolute neutrophil count < 1,000)
3. A diagnosis of major depressive disorder, anxiety disorder, panic disorder, or other psychiatric disorders; caffeine, alcohol, or drug addiction; or a subscale of either anxiety or depression in Hamilton Anxiety and Depression Scale (HADS) score = 11 points
4. Level of cancer pain measured by numeric rating scale = 4
5. Six months or less life expectancy
6. A plan of surgery, chemotherapy, radiotherapy during the study
7. A recent change of types or dosages of regular medication in the previous 4 weeks to alleviate insomnia
8. Having taken sleeping pills as required in the previous 2 weeks to alleviate insomnia
9. Having undergone Korean medical treatment (e.g. acupuncture, moxibustion, cupping, herbal medicine, etc.) in the previous 4 weeks
10. Past history in the previous 4 weeks or a new plan during the study of initiating dietary supplements or non-pharmacologic therapies (e.g. cognitive behavioral therapy, exercise etc.) to alleviate insomnia
11. Working shifts or changes in day/night work schedule that could impact circadian rhythm
12. Suffering from pain severe enough to cause sleep disturbance or presence of any disease that could cause insomnia
13. Taking medication for a cardiovascular or hemostatic disorder
14. Abnormal findings in thyroid function test (abnormal level of free thyroxine [free T4] and thyroid stimulating hormone [TSH] < 0.1 uIU/ml or TSH > 5.1 uIU/ml)
15. A previous hypersensitivity reaction to acupuncture or difficulty cooperating with acupuncture therapy
16. The presence of implants that could interfere with electroacupuncture or a history of hypersensitivity to electrostimulation
17. Pregnancy, lactation, or planning a pregnancy
18. Having participated in other clinical trials in the previous 4weeks
19. Difficulty complying with the treatment, questionnaire, or study protocol

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change of total scores in the Insomnia Severity Index (ISI)

Secondary Outcome Measures

Name	Time	Method
Mean change of total scores in the ISI;Mean change of total scores in the Pittsburgh Sleep Quality Index (PSQI);Mean change of total scores in the Korean version of Montreal Cognitive Assessment (MoCA-K);Mean change of total scores in the Functional Assessment of Cancer Therapy-Fatigue (FACT-F);Quality of sleep measured by sleep diary;Quality of sleep measured by actigraph;Salivary melatonin and cortisol;Adverse event ;Blinding test ;Credibility questionnaire