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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01136083
First Posted: June 3, 2010
Last Update Posted: August 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
  Purpose

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

  1. circulating VEGF-A
  2. muscle growth and function
  3. Myostatin

Condition Intervention
Non-small-cell Lung Cancer Behavioral: Exercise training Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Exercise Training on Angiogenesis and Cachexia in Lung Cancer Patients

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Exercise capacity [ Time Frame: 8 weeks after the start of the intervention ]
    Maximal oxygen consumption with Vmax229 Vastus lateral muscle oxygenation with NIRS


Secondary Outcome Measures:
  • Imaging of muscle [ Time Frame: 8 weeks and 16 weeks after the start of the intervention ]
    Measured by MRS

  • Analysis of venous blood sample [ Time Frame: 8 weeks andd 16 weeks after the start of the intervention ]
    Analysis of circulating VEGF-A and myostatin

  • Quality of life [ Time Frame: baseline, 8 weeks, 16 weeks ]
    Measured by questionnaire

  • Exercise capacity [ Time Frame: 16 weeks after the start of the intervention ]
    Maximal oxygen consumption with Vmax229 Vastus lateral muscle oxygenation with NIRS

  • Muscle function [ Time Frame: 8 weeks and 16 weeks after the start of the intervention ]
    Isokinetic muscle strength and endurance with Biodex

  • Physical activity [ Time Frame: 8 weeks andd 16 weeks after the start of the intervention ]
    Measured with 7-day recall questionnaire

  • Dietary intake [ Time Frame: 8 weeks andd 16 weeks after the start of the intervention ]
    Measured with 24-hour recall questionnaire

  • Body composition [ Time Frame: 8 weeks andd 16 weeks after the start of the intervention ]

    Body mass index calculated with body weight and height

    % body fat abd free-fat mass with BIA



Enrollment: 60
Study Start Date: September 2010
Study Completion Date: August 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise training
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.
Behavioral: Exercise training
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.
Other Name: High intensity interval aerobic training
Active Comparator: Control group
Subjects in control group will not undergo individualized high aerobic interval training on treadmill. They will receive usual care as normally does in hospital.
Other: Usual care
Subjects in control group will not undergo individualized high aerobic interval training on treadmill. They will receive usual care as normally does in hospital.
Other Name: Non-exercise or patient education

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136083


Locations
Taiwan
National Taiwan University Hospital
Taipei City, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Ying-Tai Wu, Ph.D National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01136083     History of Changes
Other Study ID Numbers: 201003064R
First Submitted: May 10, 2010
First Posted: June 3, 2010
Last Update Posted: August 13, 2013
Last Verified: November 2011

Keywords provided by National Taiwan University Hospital:
Tumor
Angiogenesis
Exercise training
VEGF
Myostatin

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Cachexia
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms