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Effectiveness of Additional Acupuncture Therapy for Lung Cancer Patients

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Acupuncture treatment
Sponsored by
Korean Medicine Hospital of Pusan National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 18 years of age
  • Karnofsky Performance Status (KPS) 60% or more
  • Undergoing antineoplastic chemotherapy for lung cancer
  • Able to provide informed consent

Exclusion Criteria:

  • Brain metastasis, stroke or major psychiatric diseases
  • Active infection
  • Severe heart disease
  • Serious systemic diseases such as uncontrolled hypertension and diabetes mellitus
  • Acupuncture therapy within the previous three months
  • Communication disorder
  • Unwillingness to participate in the trial
  • Severe immunocompromised state (absolute neutrophils count < 1000/cubic mm)

Sites / Locations

  • Pusan National University Yangsan Hospital and Korean Medicine Hospital of Pusan National University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acupuncture therapy

Arm Description

Outcomes

Primary Outcome Measures

Change score of Functional Assessment of Cancer Therapy-Lung (FACT-L) scale from baseline

Secondary Outcome Measures

Change score of Functional Assessment of Cancer Therapy-Lung (FACT-L) scale from baseline
Change score of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT fatigue) Scale from baseline
Change of general condition assessment using visual analogue scale from baseline
Adverse events

Full Information

First Posted
July 28, 2011
Last Updated
September 1, 2015
Sponsor
Korean Medicine Hospital of Pusan National University
Collaborators
Pusan National University Yangsan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01408212
Brief Title
Effectiveness of Additional Acupuncture Therapy for Lung Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
low recruiting
Study Start Date
July 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korean Medicine Hospital of Pusan National University
Collaborators
Pusan National University Yangsan Hospital

4. Oversight

5. Study Description

Brief Summary
This study aims for evaluating the effectiveness, safety and feasibility of additional acupuncture therapy for lung cancer patients who are under chemotherapy in an inpatient setting. The acupuncture therapy will be administered during a resting period between cycles of chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture therapy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Acupuncture treatment
Intervention Description
Acupuncture treatment will be performed by licensed doctors in Korean Medicine using 0.20 mm (diameter) X 0.30 mm (length) sized disposable acupuncture on seven to ten consecutive days after admission to the Korean Medicine Hospital of Pusan National University. At least two sessions and a maximum of five sessions of acupuncture therapy will be administered per day. Acupuncture points consist of common points and additional points selected for typical complaints common in patients under chemotherapy. These points are as follows. Common points: LI4 (bilateral), LU5 (bilateral), LU7 (bilateral), BL13 (bilateral), BL23 (bilateral), SP3 (bilateral), LU9 (bilateral), ST36 (bilateral) and CV22 Additional points Nausea/vomiting PC6 (bilateral) Dyspepsia: CV12, LU6 (bilateral) Insomnia: Yintang, KI5 (bilateral) Pain: Ashi points (tender spots)
Primary Outcome Measure Information:
Title
Change score of Functional Assessment of Cancer Therapy-Lung (FACT-L) scale from baseline
Time Frame
7-10 days during a rest period between chemotherapy cycles
Secondary Outcome Measure Information:
Title
Change score of Functional Assessment of Cancer Therapy-Lung (FACT-L) scale from baseline
Time Frame
4-5 weeks from baseline (3-4 weeks after treatment termination)
Title
Change score of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT fatigue) Scale from baseline
Time Frame
Baseline, 7-10 days after baseline, 4-5 weeks after baseline
Title
Change of general condition assessment using visual analogue scale from baseline
Time Frame
Baseline, 7-10 days after baseline, 4-5 weeks after baseline
Title
Adverse events
Time Frame
From study enrollment to the last follow-up (a maximum of day 36)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years of age Karnofsky Performance Status (KPS) 60% or more Undergoing antineoplastic chemotherapy for lung cancer Able to provide informed consent Exclusion Criteria: Brain metastasis, stroke or major psychiatric diseases Active infection Severe heart disease Serious systemic diseases such as uncontrolled hypertension and diabetes mellitus Acupuncture therapy within the previous three months Communication disorder Unwillingness to participate in the trial Severe immunocompromised state (absolute neutrophils count < 1000/cubic mm)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun Seong Kim, PhD
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jun-Yong Choi, MS
Organizational Affiliation
Korean Medicine Hospital of Pusan National University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital and Korean Medicine Hospital of Pusan National University
City
Yangsan
State/Province
Gyeongsangnam-do
ZIP/Postal Code
626-770
Country
Korea, Republic of

12. IPD Sharing Statement

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Effectiveness of Additional Acupuncture Therapy for Lung Cancer Patients

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