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

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01136083
First received: May 10, 2010
Last updated: August 12, 2013
Last verified: November 2011
  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 Blind (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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measured by MRS

  • Analysis of venous blood sample [ Time Frame: 8 weeks andd 16 weeks after the start of the intervention ] [ Designated as safety issue: No ]
    Analysis of circulating VEGF-A and myostatin

  • Quality of life [ Time Frame: baseline, 8 weeks, 16 weeks ] [ Designated as safety issue: No ]
    Measured by questionnaire

  • Exercise capacity [ Time Frame: 16 weeks after the start of the intervention ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Isokinetic muscle strength and endurance with Biodex

  • Physical activity [ Time Frame: 8 weeks andd 16 weeks after the start of the intervention ] [ Designated as safety issue: No ]
    Measured with 7-day recall questionnaire

  • Dietary intake [ Time Frame: 8 weeks andd 16 weeks after the start of the intervention ] [ Designated as safety issue: No ]
    Measured with 24-hour recall questionnaire

  • Body composition [ Time Frame: 8 weeks andd 16 weeks after the start of the intervention ] [ Designated as safety issue: No ]

    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

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01136083     History of Changes
Other Study ID Numbers: 201003064R
Study First Received: May 10, 2010
Last Updated: August 12, 2013
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014