Non-Small Cell Lung Cancer, Lung Cancer
Conditions
Keywords
Acupuncture, electrical stimulation of acupoints, chemotherapy, Diyu Shengbai Pian, nursing care
Brief summary
To investigate the effect of percutaneous electrical stimulation on chemotherapy-induced bone marrow suppression in patients with lung cancer.
Detailed description
Lung cancer is the malignant neoplasm with the highest incidence and mortality in China as well as worldwide. Non-small cell lung cancer (NSCLC) accounts for 80%-85% of all lung cancer cases. Chemotherapy is the preferred treatment method for NSCLC, but many patients cannot tolerate the adverse reactions of chemotherapy. Among the most common and most severe adverse reactions is bone marrow suppression. The more serious the bone marrow suppression, the higher the direct medical cost of chemotherapy. Literatures showed Acupuncture was used to treat patients with chemotherapy-induced bone marrow suppression. In this study, the effect of percutaneous electrical stimulation of acupoints including Dazhui (DU14), Geshu (BL17), Zusanli (ST36), Sanyinjiao (SP6), and Hegu (LI4) will be investigated, compared with the medication group treated by oral administration of prophylactic agents, and the control group received routine nursing care on chemotherapy-induced bone marrow suppression in patients with lung cancer.
Interventions
DEVICETEAS
The patients will be treated by their assigned acupuncture stimulation in 7 days. The surface electrical stimulation devices and application parameter are: G6805-II pulse acupuncture treatment instrument from Shanghai Medical Technology Company, Ltd (Shanghai, China); sparse-dense wave stimulation (sparse wave 30Hz; dense wave 100Hz) with an intensity of 6-15 V; and the corresponding parts of the body experienced a slight quiver, with a duration 20 minutes each time.
DRUGSanguisorba officinalis L.
Sanguisorba officinalis L., a Leukogenic medication, named Diyu Shengbai Pian (Chengdu Diao Tianfu Pharmaceutical Group Co., Ltd., China) will be taken 0.4g each time by 3 times per day.
Sponsors
Tongji University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of Non-small cell lung cancer(NSCLC) * age between 20 and 75 years * chemotherapy naive after diagnosis * GP regimen as treatment * an expected survival of more than 12 weeks based on a score equal to or greater than 60 points on Karnofsky performance status (KPS) scale * the ability to understand and speak Mandarin
Exclusion criteria
* diagnosis of a hematological system tumor * mental illness * bone marrow suppression prior to chemotherapy * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Blood routine indexes in 1 month | Day 0, Day 5, Day 8, Day 11, Day 14, Day 21 and Day 28 | The routine blood examinations of indicators of bone marrow suppression, including red blood cells (10\^12/L), hemoglobin (g/L), white blood cells (10\^9/L), and platelets (10\^9/L). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Comfort Degree | Day 0, Day 8, and Day 28 | The Comfort Scale is assessed using General Comfort Questionnaire designed by KY Kolcaba. A preliminary experiment was conducted in 30 patients with NSCLC before the first visit, and the reliability coefficient of the scale was calculated; Cronbach's alpha = 0.932 indicated high internal consistency. |
Countries
China
Contacts
Primary ContactLili Hou, Master
Outcome results
None listed