Effectiveness of Additional Acupuncture Therapy for Lung Cancer Patients

This study has been terminated.
(low recruiting)
Sponsor:
Collaborator:
Pusan National University Yangsan Hospital
Information provided by (Responsible Party):
Jun-Yong Choi, Korean Medicine Hospital of Pusan National University
ClinicalTrials.gov Identifier:
NCT01408212
First received: July 28, 2011
Last updated: September 1, 2015
Last verified: September 2015
  Purpose
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.

Condition Intervention
Lung Cancer
Procedure: Acupuncture treatment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Korean Medicine Hospital of Pusan National University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change of general condition assessment using visual analogue scale from baseline [ Time Frame: Baseline, 7-10 days after baseline, 4-5 weeks after baseline ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: From study enrollment to the last follow-up (a maximum of day 36) ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: July 2011
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408212

Locations
Korea, Republic of
Pusan National University Yangsan Hospital and Korean Medicine Hospital of Pusan National University
Yangsan, Gyeongsangnam-do, Korea, Republic of, 626-770
Sponsors and Collaborators
Korean Medicine Hospital of Pusan National University
Pusan National University Yangsan Hospital
Investigators
Principal Investigator: Yun Seong Kim, PhD Pusan National University Yangsan Hospital
Principal Investigator: Jun-Yong Choi, MS Korean Medicine Hospital of Pusan National University
  More Information

Responsible Party: Jun-Yong Choi, Associate professor, Korean Medicine Hospital of Pusan National University
ClinicalTrials.gov Identifier: NCT01408212     History of Changes
Other Study ID Numbers: KCRC-IRB-2011009 & L-2011-170 
Study First Received: July 28, 2011
Last Updated: September 1, 2015
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 27, 2016