Transcutaneous Electrical Acupoint Stimulation for Non-small Cell Lung Cancer Patients
January 21, 2016 updated by: Caicun Zhou, Tongji University
Transcutaneous Electrical Acupoint Stimulation Ameliorates Chemotherapy-Induced Bone Marrow Suppression in Lung Cancer Patients
To investigate the effect of percutaneous electrical stimulation on chemotherapy-induced bone marrow suppression in patients with lung cancer.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200433
- Recruiting
- Shanghai Pulmonary Hospital Medical Oncology Department
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: TEAS group
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).
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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.
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Active Comparator: Medication group
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.
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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.
Other Names:
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No Intervention: Control group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change of Blood routine indexes in 1 month
Time Frame: Day 0, Day 5, Day 8, Day 11, Day 14, Day 21 and Day 28
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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).
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Day 0, Day 5, Day 8, Day 11, Day 14, Day 21 and Day 28
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of Comfort Degree
Time Frame: Day 0, Day 8, and Day 28
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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.
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Day 0, Day 8, and Day 28
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Caicun Zhou, Doctor, Shanghai Pulmonary Hospital of Tongji University, Shanghai, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
January 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
January 15, 2016
First Submitted That Met QC Criteria
January 21, 2016
First Posted (Estimate)
January 26, 2016
Study Record Updates
Last Update Posted (Estimate)
January 26, 2016
Last Update Submitted That Met QC Criteria
January 21, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TEAS_001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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