Effectiveness of Additional Acupuncture Therapy for Lung Cancer Patients

Lung Cancer Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01408212
• Other study ID #: KCRC-IRB-2011009 & L-2011-170
• Status: Terminated
• Phase: N/A
• First received: July 28, 2011
• Last updated: September 1, 2015
• Start date: July 2011
• Est. completion date: December 2012

Study information

• Verified date: September 2015
• Source: Korean Medicine Hospital of Pusan National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital and Korean Medicine Hospital of Pusan National University	Yangsan	Gyeongsangnam-do

Sponsors (2)

Lead Sponsor	Collaborator
Korean Medicine Hospital of Pusan National University	Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change score of Functional Assessment of Cancer Therapy-Lung (FACT-L) scale from baseline		7-10 days during a rest period between chemotherapy cycles	No
Secondary	Change score of Functional Assessment of Cancer Therapy-Lung (FACT-L) scale from baseline		4-5 weeks from baseline (3-4 weeks after treatment termination)	No
Secondary	Change score of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT fatigue) Scale from baseline		Baseline, 7-10 days after baseline, 4-5 weeks after baseline	No
Secondary	Change of general condition assessment using visual analogue scale from baseline		Baseline, 7-10 days after baseline, 4-5 weeks after baseline	No
Secondary	Adverse events		From study enrollment to the last follow-up (a maximum of day 36)	Yes