Non-Small Cell Lung CancerNCT02663492
Transcutaneous Electrical Acupoint Stimulation for Non-small Cell Lung Cancer Patients
A study testing TEAS and Sanguisorba officinalis L. in people with Non-Small Cell Lung Cancer and Lung Cancer, run by Tongji University at 1 site in China.
Trial summary
To investigate the effect of percutaneous electrical stimulation on chemotherapy-induced bone marrow suppression in patients with lung cancer. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer, Lung Cancer
- What is being tested?
- TEAS and Sanguisorba officinalis L.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- diagnosis of a hematological system tumor
- mental illness
- bone marrow suppression prior to chemotherapy
- pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital Medical Oncology Department
Shanghai, Shanghai Municipality, 200433
Ying Xu, MD, 86-21-65115006 ext. 1053, xuying2186@hotmail.com
Di Zheng, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer, Lung Cancer
- Being tested
- TEAS, Sanguisorba officinalis L.
- Keywords
- Acupuncture, electrical stimulation of acupoints, chemotherapy, Diyu Shengbai Pian, nursing care
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEASDevice
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.
Sanguisorba officinalis L.Drug
Also called Diyu Shengbai Pian
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.
| Study group | Role | What they receive |
|---|---|---|
| TEAS group | Experimental | 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). Receives: Device: TEAS |
| Medication group | Active comparator | 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. Receives: Drug: Sanguisorba officinalis L. |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 0, Day 5, Day 8, Day 11, Day 14, Day 21 and Day 28
Secondary outcomes (1)
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.
Measured: Day 0, Day 8, and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startAug 2014
- Primary completionJan 2016
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caicun Zhou, Tongji University
- Investigators
- Caicun Zhou, Doctor, Principal investigator, Shanghai Pulmonary Hospital of Tongji University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663492
- Sponsor's protocol ID
- TEAS_001
- Status last verified
- Jan 2016
- First submitted
- 15 Jan 2016
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Acupoint Stimulation Ameliorates Chemotherapy-Induced Bone Marrow Suppression in Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT02663492
- Acronym / sponsor ID
- TEAS_001
- Conditions
- Non-Small Cell Lung Cancer, Lung Cancer
- Keywords
- Acupuncture, electrical stimulation of acupoints, chemotherapy, Diyu Shengbai Pian, nursing care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TEAS group | Experimental | Device: TEASPatients with transcutaneous electrical acupoint stimulation (TEAS) group receive electrical stimulation of acupoints including Dazhui (DU14), Geshu (BL17), Zusanli (ST36), Sanyinjiao (SP6), and Hegu (LI4). |
| Medication group | Active comparator | Drug: Sanguisorba officinalis L.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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- diagnosis of a hematological system tumor
- mental illness
- bone marrow suppression prior to chemotherapy
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEASThe 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. | Device | TEAS group |
| Sanguisorba officinalis L.Also: Diyu Shengbai PianSanguisorba 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. | Drug | Medication group |
Primary outcome
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
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).
1 secondary outcome
Change of Comfort Degree
Time frame: Day 0, Day 8, and Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caicun Zhou, Doctor principal investigator
Shanghai Pulmonary Hospital of Tongji University, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEAS and Sanguisorba officinalis L. in people with Non-Small Cell Lung Cancer and Lung Cancer, run by Tongji University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lili Hou, Master (8613816033620, qing_0_122@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2016.