NCT02121379

Brief Summary

Pulmonary rehabilitation might be benificial in advanced lung cancer patients with COPD who undergo cytotoxic chemotherapy. We will compare two groups, 8 week pulmonary rehabilitation group and usual care group.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

June 2, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

April 18, 2014

Last Update Submit

May 30, 2014

Conditions

COPDLung Cancer

Outcome Measures

Primary Outcomes (1)

  • difference of VO2 max

    difference maximal oxygen consumption during exercise cardiopulmonary test between before and after intervention/control

    8 weeks

Secondary Outcomes (4)

  • difference of Saint George's Respiratory Questionannaire (SGRQ) score

    8 weeks

  • difference of pulmonary function test

    8 weeks

  • difference of 6 min walk test

    8 weeks

  • difference of depression test

    8 weeks

Study Arms (2)

control

NO INTERVENTION

stretching exercise

pulmonary rehablitation

EXPERIMENTAL

warming up exercise strengthening exercise aerobic exercise cool down

Behavioral: pulmonary rehabilitation

Interventions

pulmonary rehabilitationBEHAVIORAL
pulmonary rehablitation

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pathologically proven lung cancer
  • chronic obstructive pulmonary disease
  • age \> 20
  • ECOG 0-1
  • cytotoxic chemotherapy

You may not qualify if:

  • other history of cancer within 5 years
  • other major disease associated with heart, lung, neurology, mental and metabolic disorders
  • osteolytic bone metastatis to weight bearing site
  • uncontrolled infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveLung Neoplasms

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasms

Central Study Contacts

Young Sik Park, Dr

CONTACT

82-2-2072-7214mdyspark@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assitant Professor

Study Record Dates

First Submitted

April 18, 2014

First Posted

April 23, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2015

Study Completion

October 1, 2015

Last Updated

June 2, 2014

Record last verified: 2014-05

Locations

KR(1)