Randomized Clinical Trial of 8 Weeks Pulmonary Rehabilitation in Advanced Stage Lung Cancer Patients With COPD During Cytotoxic Chemotherapy

May 30, 2014 updated by: Young Sik Park, Seoul National University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
stretching exercise
Experimental: pulmonary rehablitation
warming up exercise strengthening exercise aerobic exercise cool down
Behavioral: pulmonary rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference of VO2 max
Time Frame: 8 weeks
difference maximal oxygen consumption during exercise cardiopulmonary test between before and after intervention/control
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference of Saint George's Respiratory Questionannaire (SGRQ) score
Time Frame: 8 weeks
the difference of SGRQ score
8 weeks
difference of pulmonary function test
Time Frame: 8 weeks
the difference of FVC and FEV1
8 weeks
difference of 6 min walk test
Time Frame: 8 weeks
the difference of 6 minute walk test
8 weeks
difference of depression test
Time Frame: 8 weeks
using Hospital Anxiety and Depression scale (HADS), measure the difference HADS between before and after intervention/control
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

April 18, 2014

First Submitted That Met QC Criteria

April 21, 2014

First Posted (Estimate)

April 23, 2014

Study Record Updates

Last Update Posted (Estimate)

June 2, 2014

Last Update Submitted That Met QC Criteria

May 30, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1401-116-549

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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