Effectiveness of Additional Acupuncture Therapy for Lung Cancer Patients

Not Applicable

Terminated

• Conditions: Lung Cancer
• Interventions: Procedure: Acupuncture treatment

• Registration Number: NCT01408212
• Lead Sponsor: Korean Medicine Hospital of Pusan National University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-28
• Study First Submitted QC: 2011-08-01
• Study First Posted: 2011-08-03
• Primary Completion: 2012-06
• Study Completion: 2012-12
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-01
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acupuncture therapy	Acupuncture treatment	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital and Korean Medicine Hospital of Pusan National University; 🇰🇷 Yangsan, Gyeongsangnam-do, Korea, Republic of