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

Lung Cancer Clinical Trial

Official title:

Transcutaneous Electrical Acupoint Stimulation Ameliorates Chemotherapy-Induced Bone Marrow Suppression in Lung Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02663492
• Other study ID #: TEAS_001
• Status: Recruiting
• Phase: N/A
• First received: January 15, 2016
• Last updated: January 21, 2016
• Start date: August 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2016
• Source: Tongji University
• Contact: Lili Hou, Master
• Phone: 8613816033620
• Email: qing_0_122[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Device:
• TEAS
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.

Drug:
• Sanguisorba 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.

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital Medical Oncology Department	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Tongji University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Day 0, Day 5, Day 8, Day 11, Day 14, Day 21 and Day 28	No
Secondary	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.	Day 0, Day 8, and Day 28	No