Electro-acupuncture for cancer-related cognitive impairment

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 15

Inclusion Criteria

1. Aged equal to or more than 19 to under 75 years
2. solid cancer occured in adult age, 6 months after finishing cancer treatment (hormone therapy is allowed)
3. Complaint of cognitive impairment with The functional assessment of cancer therapy-cognitive function-perceived cognitive impairments (FACT-cog-PCI score) <63
4. Cognitive impairment is suppose to be accompanied with cancer treatment
5. Eastern cooperative oncology group (ECOG) performance status 0~2
6. agreed with written informed consent

Exclusion Criteria

1. currently receiving any of cognitive rehabilitation therapy, herbal medicine or conventional treatment for cognitive impairment; or having experiences of those treatment within 2 weeks
2. history of tumor in central nervous system (CNS), intra-cranial radiotherapy, or intrathecal chemotherapy; or history of CNS diseases which can affect cognitive function
3. Recurrence, metastasis or progression of cancer
4. history of psycological disorders including alcohol dependence, major depressive disorder, schizophrenia or bipolar disorder
5. Korean Vision of Mini-Mental State Exam (K-MMSE) score <20
6. score of any field of Hospital anxiety and depression scale (HADS) is equal to or greater than 11
7. One or more of belows: Platelet count = 60,000/µL, Hemoglobin < 8g/dL, or absolute neutrophil count < 1,000
8. abnormal values of liver function test (LFT) or renal function test (RFT), serious hepatic/renal failure (equal to or more than two times of upper limit of AST or ALT or creatinine = 2.0mg/dL )
9. suspected clinically significant inflammation with CRP = 10mg/L and WBC > 10,000/µL
10. serum albumin value under normal range and poor oral intake
11. seriously unstable medical condition such as abnormal condition demanding medical intervention or management
12. life expectancy = 6 months
13. planning operation, chemotherapy or radiotherapy during the clinical trial period
14. receiving active treatment for anemia (erythropoietin or blood transfusion)
15. history of hypersensitivity reaction to acupuncture or electroacupuncture; or difficult to cooperate for the intervention
16. inserted prosthesis which is inappropriate for electroacupuncture (pace maker, a heart-lung machine, an electroacrdiograph etc.), or who has possibility of hypersensitivity reaction to electroacupuncture including epilepsy
17. currently being enrolled on another clinical trial or it is not passed 4 weeks after completion of previous clinical trial
18. pregnant women, lactating women, or planning for pregnancy
19. difficult to comply the treatment, visit or reponse to questionnaires etc.

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy-Cognitive Function (Fact-Cog)

Secondary Outcome Measures

Name	Time	Method
European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire C30 (EORTC-QLQ-C30);Korean version of Montreal Cognitive Assessment (MoCA-K);Hospital anxiety and depression scale (HADS);The Seoul Neuropsychological Screening Battery (SNSB);Measure Yourself Medical Outcome Profile (MYMOP V2);Adverse event