Effect of Exercise Training on Angiogenesis and Cachexia in Lung Cancer Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by National Taiwan University Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
National Taiwan University Hospital
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01136083
First received: May 10, 2010
Last updated: November 25, 2010
Last verified: September 2010
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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
- circulating VEGF-A
- muscle growth and function
- 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 ]Measure 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 ]Meausred 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
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | August 2012 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136083
Contacts
| Contact: Ying-Tai Wu, Ph. D | 886-2-33668129 | ytw@ntu.edu.tw |
Locations
| Taiwan | |
| National Taiwan University Hospital | Recruiting |
| Taipei City, Taiwan, 100 | |
| Principal Investigator: Ying-Tai Wu, Ph. D | |
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: | Ying-Tai Wu, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University |
| ClinicalTrials.gov Identifier: | NCT01136083 History of Changes |
| Other Study ID Numbers: | 201003064R |
| Study First Received: | May 10, 2010 |
| Last Updated: | November 25, 2010 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
Tumor Angiogenesis Exercise training VEGF Myostatin |
Additional relevant MeSH terms:
|
Cachexia Carcinoma, Non-Small-Cell Lung Lung Neoplasms Emaciation Weight Loss Body Weight Changes Body Weight Signs and Symptoms |
Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013