NCT01408212

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 2, 2015

Status Verified

September 1, 2015

Enrollment Period

11 months

First QC Date

July 28, 2011

Last Update Submit

September 1, 2015

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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)

Study Arms (1)

Acupuncture therapy

EXPERIMENTAL
Procedure: Acupuncture treatment

Interventions

Acupuncture treatmentPROCEDURE

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)

Acupuncture therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age
  • Karnofsky Performance Status (KPS) 60% or more
  • Undergoing antineoplastic chemotherapy for lung cancer
  • Able to provide informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Yangsan Hospital and Korean Medicine Hospital of Pusan National University

Yangsan, Gyeongsangnam-do, 626-770, South Korea

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Yun Seong Kim, PhD

    Pusan National University Yangsan Hospital

    PRINCIPAL INVESTIGATOR

  • Jun-Yong Choi, MS

    Korean Medicine Hospital of Pusan National University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 28, 2011

First Posted

August 3, 2011

Study Start

July 1, 2011

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

September 2, 2015

Record last verified: 2015-09

Locations

KR(1)