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

Primary Purpose

COPD, Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pulmonary rehabilitation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control

pulmonary rehablitation

Arm Description

stretching exercise

warming up exercise strengthening exercise aerobic exercise cool down

Outcomes

Primary Outcome Measures

difference of VO2 max
difference maximal oxygen consumption during exercise cardiopulmonary test between before and after intervention/control

Secondary Outcome Measures

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

Full Information

First Posted
April 18, 2014
Last Updated
May 30, 2014
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02121379
Brief Title
Randomized Clinical Trial of 8 Weeks Pulmonary Rehabilitation in Advanced Stage Lung Cancer Patients With COPD During Cytotoxic Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Description
stretching exercise
Arm Title
pulmonary rehablitation
Arm Type
Experimental
Arm Description
warming up exercise strengthening exercise aerobic exercise cool down
Intervention Type
Behavioral
Intervention Name(s)
pulmonary rehabilitation
Primary Outcome Measure Information:
Title
difference of VO2 max
Description
difference maximal oxygen consumption during exercise cardiopulmonary test between before and after intervention/control
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
difference of Saint George's Respiratory Questionannaire (SGRQ) score
Description
the difference of SGRQ score
Time Frame
8 weeks
Title
difference of pulmonary function test
Description
the difference of FVC and FEV1
Time Frame
8 weeks
Title
difference of 6 min walk test
Description
the difference of 6 minute walk test
Time Frame
8 weeks
Title
difference of depression test
Description
using Hospital Anxiety and Depression scale (HADS), measure the difference HADS between before and after intervention/control
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Young Sik Park, Dr
Phone
82-2-2072-7214
Email
mdyspark@gmail.com
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Sik Park, Dr
Phone
82-2-2072-7214
Email
mdyspark@gmail.com

12. IPD Sharing Statement

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

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