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

Non-small-cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01136083
• Other study ID #: 201003064R
• Status: Completed
• Phase: N/A
• First received: May 10, 2010
• Last updated: August 12, 2013
• Start date: September 2010
• Est. completion date: August 2012

Study information

• Verified date: November 2011
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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

1. circulating VEGF-A

2. muscle growth and function

3. Myostatin

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small-cell Lung Cancer

Intervention

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:
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei City

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise capacity	Maximal oxygen consumption with Vmax229 Vastus lateral muscle oxygenation with NIRS	8 weeks after the start of the intervention	No
Secondary	Imaging of muscle	Measured by MRS	8 weeks and 16 weeks after the start of the intervention	No
Secondary	Analysis of venous blood sample	Analysis of circulating VEGF-A and myostatin	8 weeks andd 16 weeks after the start of the intervention	No
Secondary	Quality of life	Measured by questionnaire	baseline, 8 weeks, 16 weeks	No
Secondary	Exercise capacity	Maximal oxygen consumption with Vmax229 Vastus lateral muscle oxygenation with NIRS	16 weeks after the start of the intervention	No
Secondary	Muscle function	Isokinetic muscle strength and endurance with Biodex	8 weeks and 16 weeks after the start of the intervention	No
Secondary	Physical activity	Measured with 7-day recall questionnaire	8 weeks andd 16 weeks after the start of the intervention	No
Secondary	Dietary intake	Measured with 24-hour recall questionnaire	8 weeks andd 16 weeks after the start of the intervention	No
Secondary	Body composition	Body mass index calculated with body weight and height; % body fat abd free-fat mass with BIA	8 weeks andd 16 weeks after the start of the intervention	No