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

Tongji University

Status: Unknown

Conditions: Lung Cancer; Non-Small Cell Lung Cancer

Treatments: Drug: Sanguisorba officinalis L.; Device: TEAS

Study type: Interventional

Funder types: Other

Identifiers

NCT02663492

TEAS_001

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups

TEAS group

Experimental group

Description:

Patients with transcutaneous electrical acupoint stimulation (TEAS) group receive electrical stimulation of acupoints including Dazhui (DU14), Geshu (BL17), Zusanli (ST36), Sanyinjiao (SP6), and Hegu (LI4).

Treatment:

Device: TEAS

Medication group

Active Comparator group

Description:

On the basis of routine nursing care, patients need to take Sanguisorba officinalis L., named Diyu Shengbai Pian (a Traditional Chinese Medicine) 3 times per day.

Treatment:

Drug: Sanguisorba officinalis L.

Control group

No Intervention group

Description:

The patients of control group receive routine nursing care, including (1) to be observed the changes in patient condition, (2) to eat high-calories, high-protein, high-vitamin, easy-to-digest foods during chemotherapy, (3) to be treated by psychological care, (4) to be prevented against the occurrence of phlebiti, and (5) to use Ondansetron and Omeprazole as direction.