NCT02663492

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable nonsmall-cell-lung-cancer

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

1.4 years

First QC Date

January 15, 2016

Last Update Submit

January 21, 2016

Conditions

Non-Small Cell Lung CancerLung Cancer

Keywords

Acupunctureelectrical stimulation of acupointschemotherapyDiyu Shengbai Piannursing care

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Change of Comfort Degree

    Day 0, Day 8, and Day 28

Study Arms (3)

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).

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.

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.

Interventions

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.

TEAS group
Sanguisorba officinalis L.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.

Also known as: Diyu Shengbai Pian
Medication group

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • diagnosis of a hematological system tumor
  • mental illness
  • bone marrow suppression prior to chemotherapy
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Pulmonary Hospital Medical Oncology Department

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Caicun Zhou, Doctor

    Shanghai Pulmonary Hospital of Tongji University, Shanghai, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lili Hou, Master

CONTACT

8613816033620qing_0_122@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 15, 2016

First Posted

January 26, 2016

Study Start

August 1, 2014

Primary Completion

January 1, 2016

Study Completion

December 1, 2016

Last Updated

January 26, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)