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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01408212 |
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Date of registration:
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28/07/2011 |
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Primary sponsor: |
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Public title:
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Effectiveness of Additional Acupuncture Therapy for Lung Cancer Patients
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Scientific title:
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Date of first enrolment:
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July 2011 |
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Target sample size:
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25 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01408212 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Jun-Yong Choi, MS |
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Address:
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Telephone:
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82-55-360-5953 |
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Email:
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kmd@pusan.ac.kr |
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Affiliation:
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Name:
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Jun-Yong Choi, MS |
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Address:
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Telephone:
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82-55-360-5953 |
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Email:
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kmd@pusan.ac.kr |
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Affiliation:
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Name:
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Jun-Yong Choi, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Korean Medicine Hospital of Pusan National University |
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Name:
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Yun Seong Kim, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pusan National University Yangsan Hospital |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lung Cancer
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Intervention(s)
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Procedure: Acupuncture treatment
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Adverse events
[Time Frame: From study enrollment to the last follow-up (a maximum of day 36)]
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Change of general condition assessment using visual analogue scale from baseline
[Time Frame: Baseline, 7-10 days after baseline, 4-5 weeks after baseline]
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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)]
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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]
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Secondary ID(s)
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KCRC-IRB-2011009 & L-2011-170
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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