Effectiveness of Additional Acupuncture Therapy for Lung Cancer Patients

Study Overview
=================
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.

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Procedure: Acupuncture treatment


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture therapy<br> | Procedure: Acupuncture treatment<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change score of Functional Assessment of Cancer Therapy-Lung (FACT-L) scale from baseline |  | 7-10 days during a rest period between chemotherapy cycles | 

Secondary Outcome Measures

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