Transcutaneous Electrical Acupoint Stimulation for Non-small Cell Lung Cancer Patients

Tongji University300 enrolled

Overview

To investigate the effect of percutaneous electrical stimulation on chemotherapy-induced bone marrow suppression in patients with lung cancer.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Non-Small Cell Lung Cancer Lung Cancer

Interventions

TEASDEVICE

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.

Sanguisorba officinalis L.DRUG

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Shanghai Pulmonary Hospital Medical Oncology Department

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Change of Blood routine indexes in 1 month

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).

Time frame: Day 0, Day 5, Day 8, Day 11, Day 14, Day 21 and Day 28

Secondary Outcomes

Change of Comfort Degree

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.

Time frame: Day 0, Day 8, and Day 28

Central Contacts

Lili Hou, Master

CONTACT

8613816033620 qing_0_122@163.com

Data from ClinicalTrials.gov

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