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

Lung Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02121379
• Other study ID #: H-1401-116-549
• Status: Recruiting
• Phase: N/A
• First received: April 18, 2014
• Last updated: May 30, 2014
• Start date: May 2014
• Est. completion date: October 2015

Study information

• Verified date: May 2014
• Source: Seoul National University Hospital
• Contact: Young Sik Park, Dr
• Phone: 82-2-2072-7214
• Email: mdyspark[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Lung Cancer

Intervention

Behavioral:
• pulmonary rehabilitation

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference of VO2 max	difference maximal oxygen consumption during exercise cardiopulmonary test between before and after intervention/control	8 weeks	No
Secondary	difference of Saint George's Respiratory Questionannaire (SGRQ) score	the difference of SGRQ score	8 weeks	No
Secondary	difference of pulmonary function test	the difference of FVC and FEV1	8 weeks	No
Secondary	difference of 6 min walk test	the difference of 6 minute walk test	8 weeks	No
Secondary	difference of depression test	using Hospital Anxiety and Depression scale (HADS), measure the difference HADS between before and after intervention/control	8 weeks	No