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

Primary Purpose

Non-Small Cell Lung Cancer, Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TEAS
Sanguisorba officinalis L.
Sponsored by
Tongji University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Acupuncture, electrical stimulation of acupoints, chemotherapy, Diyu Shengbai Pian, nursing care

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shanghai Pulmonary Hospital Medical Oncology DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

TEAS group

Medication group

Control group

Arm 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).

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
January 15, 2016
Last Updated
January 21, 2016
Sponsor
Tongji University
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1. Study Identification

Unique Protocol Identification Number
NCT02663492
Brief Title
Transcutaneous Electrical Acupoint Stimulation for Non-small Cell Lung Cancer Patients
Official Title
Transcutaneous Electrical Acupoint Stimulation Ameliorates Chemotherapy-Induced Bone Marrow Suppression in Lung Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer, Lung Cancer
Keywords
Acupuncture, electrical stimulation of acupoints, chemotherapy, Diyu Shengbai Pian, nursing care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TEAS group
Arm Type
Experimental
Arm 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).
Arm Title
Medication group
Arm Type
Active Comparator
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
TEAS
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sanguisorba officinalis L.
Other Intervention Name(s)
Diyu Shengbai Pian
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Blood routine indexes in 1 month
Description
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 Outcome Measure Information:
Title
Change of Comfort Degree
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lili Hou, Master
Phone
8613816033620
Email
qing_0_122@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caicun Zhou, Doctor
Organizational Affiliation
Shanghai Pulmonary Hospital of Tongji University, Shanghai, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Pulmonary Hospital Medical Oncology Department
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Xu, MD
Phone
86-21-65115006
Ext
1053
Email
xuying2186@hotmail.com
First Name & Middle Initial & Last Name & Degree
Di Zheng, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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