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

NCT01136083 | Completed

• 1 other identifier: 201003064R
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Non-small-cell Lung Cancer

Keywords

Tumor; Angiogenesis; Exercise training; VEGF; Myostatin

Outcome Measures

Primary Outcomes (1)

• Exercise capacity

  Maximal oxygen consumption with Vmax229 Vastus lateral muscle oxygenation with NIRS

  8 weeks after the start of the intervention

Secondary Outcomes (8)

• Imaging of muscle

  8 weeks and 16 weeks after the start of the intervention

• Analysis of venous blood sample

  8 weeks andd 16 weeks after the start of the intervention

• Quality of life

  baseline, 8 weeks, 16 weeks

• Exercise capacity

  16 weeks after the start of the intervention

• Muscle function

  8 weeks and 16 weeks after the start of the intervention

Study Arms (2)

Exercise training

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Exercise training BEHAVIORAL

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.

Also known as: High intensity interval aerobic training

Exercise training

Usual care OTHER

Subjects in control group will not undergo individualized high aerobic interval training on treadmill. They will receive usual care as normally does in hospital.

Also known as: Non-exercise or patient education

Control group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe metastasis, cardiopulmonary or musculoskeletal conditions may affect participation in exercise
• Do not understand the verbal or written instructions

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms

Interventions

Exercise; Patient Education as Topic

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ying-Tai Wu, Ph.D

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: June 3, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2012
• Last Updated: August 13, 2013

Record last verified: 2011-11

Locations

TW (1)