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

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

Study Overview

• Status: Completed
• Conditions: Non-small-cell Lung Cancer
• Intervention / Treatment: Behavioral: Exercise training; Other: Usual care

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Non-exercise or patient education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise capacity	Maximal oxygen consumption with Vmax229 Vastus lateral muscle oxygenation with NIRS	8 weeks after the start of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Imaging of muscle	Measured by MRS	8 weeks and 16 weeks after the start of the intervention
Analysis of venous blood sample	Analysis of circulating VEGF-A and myostatin	8 weeks andd 16 weeks after the start of the intervention
Quality of life	Measured by questionnaire	baseline, 8 weeks, 16 weeks
Exercise capacity	Maximal oxygen consumption with Vmax229 Vastus lateral muscle oxygenation with NIRS	16 weeks after the start of the intervention
Muscle function	Isokinetic muscle strength and endurance with Biodex	8 weeks and 16 weeks after the start of the intervention
Physical activity	Measured with 7-day recall questionnaire	8 weeks andd 16 weeks after the start of the intervention
Dietary intake	Measured with 24-hour recall questionnaire	8 weeks andd 16 weeks after the start of the intervention
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: National Science Council, Taiwan

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: May 10, 2010
• First Submitted That Met QC Criteria: June 2, 2010
• First Posted (Estimate): June 3, 2010

Study Record Updates

• Last Update Posted (Estimate): August 13, 2013
• Last Update Submitted That Met QC Criteria: August 12, 2013
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: VEGF; Angiogenesis; Exercise training; Tumor; Myostatin
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Body Weight; Respiratory Tract Neoplasms; Thoracic Neoplasms; Body Weight Changes; Emaciation; Weight Loss; Lung Neoplasms; Cachexia
• Other Study ID Numbers: 201003064R