Effectiveness of Additional Acupuncture Therapy for Lung Cancer Patients

September 1, 2015 updated by: Jun-Yong Choi, Korean Medicine Hospital of Pusan National University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeongsangnam-do
      • Yangsan, Gyeongsangnam-do, Korea, Republic of, 626-770
        • Pusan National University Yangsan Hospital and Korean Medicine Hospital of Pusan National University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Acupuncture therapy
Procedure: Acupuncture treatment

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
7-10 days during a rest period between chemotherapy cycles

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
4-5 weeks from baseline (3-4 weeks after treatment termination)
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
Baseline, 7-10 days after baseline, 4-5 weeks after baseline
Change of general condition assessment using visual analogue scale from baseline
Time Frame: Baseline, 7-10 days after baseline, 4-5 weeks after baseline
Baseline, 7-10 days after baseline, 4-5 weeks after baseline
Adverse events
Time Frame: From study enrollment to the last follow-up (a maximum of day 36)
From study enrollment to the last follow-up (a maximum of day 36)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korean Medicine Hospital of Pusan National University

Collaborators

Pusan National University Yangsan Hospital

Investigators

  • Principal Investigator: Yun Seong Kim, PhD, Pusan National University Yangsan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

July 28, 2011

First Submitted That Met QC Criteria

August 1, 2011

First Posted (ESTIMATE)

August 3, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 2, 2015

Last Update Submitted That Met QC Criteria

September 1, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCRC-IRB-2011009 & L-2011-170

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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