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Effect of Exercise Training on Angiogenesis and Cachexia in Lung Cancer Patients

Primary Purpose

Non-small-cell Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Exercise training
Usual care
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small-cell Lung Cancer focused on measuring Tumor, Angiogenesis, Exercise training, VEGF, Myostatin

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 40-75 years
  • Advanced NSCLC
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Targeted therapy for at least 8 weeks
  • Stable condition

Exclusion Criteria:

  • Severe metastasis, cardiopulmonary or musculoskeletal conditions may affect participation in exercise
  • Do not understand the verbal or written instructions

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise training

Control group

Arm Description

Subjects in exercise group will undergo individualized high aerobic interval training on treadmill for 30 minutes under the supervision of an experienced physical therapist 3 times a week and home exercise twice a week with accelerometer.

Subjects in control group will not undergo individualized high aerobic interval training on treadmill. They will receive usual care as normally does in hospital.

Outcomes

Primary Outcome Measures

Exercise capacity
Maximal oxygen consumption with Vmax229 Vastus lateral muscle oxygenation with NIRS

Secondary Outcome Measures

Imaging of muscle
Measured by MRS
Analysis of venous blood sample
Analysis of circulating VEGF-A and myostatin
Quality of life
Measured by questionnaire
Exercise capacity
Maximal oxygen consumption with Vmax229 Vastus lateral muscle oxygenation with NIRS
Muscle function
Isokinetic muscle strength and endurance with Biodex
Physical activity
Measured with 7-day recall questionnaire
Dietary intake
Measured with 24-hour recall questionnaire
Body composition
Body mass index calculated with body weight and height % body fat abd free-fat mass with BIA

Full Information

First Posted
May 10, 2010
Last Updated
August 12, 2013
Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01136083
Brief Title
Effect of Exercise Training on Angiogenesis and Cachexia in Lung Cancer Patients
Official Title
Effect of Exercise Training on Angiogenesis and Cachexia in Lung Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Cancer is one of the leading health issues in this country and worldwide. Angiogenesis is an essential process for tumoral growth and metastasis. This process is dependent on the balance between angiogenic factors and antiangiogenic factors. Muscle wasting has been associated with myostatin overexpression in cancer. Exercise training can depress tumor growth and suppress myostatin expression, and enhance skeletal muscle angiogenesis in healthy people and some animal studies. The purpose of this study is mainly to investigate the effects of exercise training on circulating VEGF-A muscle growth and function Myostatin

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small-cell Lung Cancer
Keywords
Tumor, Angiogenesis, Exercise training, VEGF, Myostatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise training
Arm Type
Experimental
Arm Description
Subjects in exercise group will undergo individualized high aerobic interval training on treadmill for 30 minutes under the supervision of an experienced physical therapist 3 times a week and home exercise twice a week with accelerometer.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Subjects in control group will not undergo individualized high aerobic interval training on treadmill. They will receive usual care as normally does in hospital.
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Other Intervention Name(s)
High intensity interval aerobic training
Intervention Description
Subjects in exercise group will undergo individualized high aerobic interval training on treadmill for 30 minutes under the supervision of an experienced physical therapist 3 times a week and home exercise twice a week with accelerometer.
Intervention Type
Other
Intervention Name(s)
Usual care
Other Intervention Name(s)
Non-exercise or patient education
Intervention Description
Subjects in control group will not undergo individualized high aerobic interval training on treadmill. They will receive usual care as normally does in hospital.
Primary Outcome Measure Information:
Title
Exercise capacity
Description
Maximal oxygen consumption with Vmax229 Vastus lateral muscle oxygenation with NIRS
Time Frame
8 weeks after the start of the intervention
Secondary Outcome Measure Information:
Title
Imaging of muscle
Description
Measured by MRS
Time Frame
8 weeks and 16 weeks after the start of the intervention
Title
Analysis of venous blood sample
Description
Analysis of circulating VEGF-A and myostatin
Time Frame
8 weeks andd 16 weeks after the start of the intervention
Title
Quality of life
Description
Measured by questionnaire
Time Frame
baseline, 8 weeks, 16 weeks
Title
Exercise capacity
Description
Maximal oxygen consumption with Vmax229 Vastus lateral muscle oxygenation with NIRS
Time Frame
16 weeks after the start of the intervention
Title
Muscle function
Description
Isokinetic muscle strength and endurance with Biodex
Time Frame
8 weeks and 16 weeks after the start of the intervention
Title
Physical activity
Description
Measured with 7-day recall questionnaire
Time Frame
8 weeks andd 16 weeks after the start of the intervention
Title
Dietary intake
Description
Measured with 24-hour recall questionnaire
Time Frame
8 weeks andd 16 weeks after the start of the intervention
Title
Body composition
Description
Body mass index calculated with body weight and height % body fat abd free-fat mass with BIA
Time Frame
8 weeks andd 16 weeks after the start of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 40-75 years Advanced NSCLC Eastern Cooperative Oncology Group performance status of 0 or 1 Targeted therapy for at least 8 weeks Stable condition Exclusion Criteria: Severe metastasis, cardiopulmonary or musculoskeletal conditions may affect participation in exercise Do not understand the verbal or written instructions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying-Tai Wu, Ph.D
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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Effect of Exercise Training on Angiogenesis and Cachexia in Lung Cancer Patients

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