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

NCT ID: NCT02663492

Last Updated: 2016-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Small Cell Lung Cancer Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

TEAS

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

Sanguisorba officinalis L.

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Diyu Shengbai Pian

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tongji University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Caicun Zhou

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Caicun Zhou, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai Pulmonary Hospital of Tongji University, Shanghai, China

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shanghai Pulmonary Hospital Medical Oncology Department

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lili Hou, Master

Role: CONTACT

8613816033620

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ying Xu, MD

Role: primary

86-21-65115006 ext. 1053

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TEAS_001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Local Treatment for Bone Metastases
NCT05665439 NOT_YET_RECRUITING NA