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Phase III Trial of Exercise Training in Postsurgical Lung

Phase 3
21 Years
80 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Phase III Trial of Exercise Training in Postsurgical Lung

The purpose of the study is look at the effects of different modalities of exercise training
and its effect on post-surgical lung cancer patients. Subjects will take part in a 16 week
training intervention that can consist of aerobic, resistance, aerobic & resistance, or a
control group. Pre and Post testing will include stress tests, echos, blood, and urine

Inclusion Criteria:

1. Histologically confirmed early-stage non-small cell or small cell lung cancer who
have undergone curative-intent complete surgical resection at Duke University Medical
Center (DUMC)

2. At least 21 years old. Children are not diagnosed with lung cancer,

3. An interval of at least 6 months following surgical resection,

4. An interval of no longer than 24 months post-resection,

5. Ability to read and understand English,

6. Primary attending oncologist approval,

7. Sedentary (i.e., patients not performing regular exercise on at least 3 days a week,
for at least 30 minutes each session, at a moderate or vigorous intensity for the
past month),

8. Willingness to be randomized,

9. Signed informed consent prior to initiation of study-related procedures, and

10. Reside within driving distance of DUMC, as necessitated by the clinic-based
assessments and supervised exercise training interventions.

Exclusion Criteria:

1. Presence of a concurrent, actively treated other malignancy or history of other
malignancy treated within the past 3 years (other than non-melanoma skin cancer),

2. Presence of metastatic disease,

3. Scheduled to receive any form of adjuvant cancer therapy (i.e., radiation,
chemotherapy, or any form of targeted therapy),

4. Pregnancy,

5. Subjects must not have any of following absolute contraindications to maximal
exercise testing as recommended by the American Thoracic Society and exercise testing
guidelines for cancer patients:

1. acute myocardial infarction (3-5 days),

2. unstable angina,

3. uncontrolled arrhythmias causing symptoms or hemodynamic compromise,

4. syncope,

5. acute endocarditis,

6. acute myocarditis or pericarditis,

7. uncontrolled heart failure,

8. acute pulmonary embolus or pulmonary infarction,

9. thrombosis of lower extremities,

10. suspected dissecting aneurysm,

11. uncontrolled asthma,

12. pulmonary edema,

13. room air desaturation at rest ≤85%,

14. respiratory failure,

15. acute noncardiopulmonary disorder that may affect exercise performance or be
aggravated by exercise,

16. mental impairment leading to inability to cooperate, and

17. extensive bone metastases.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

To determine the effects of aerobic training and resistance training, relative to an attention-control group, on exercise capacity

Outcome Time Frame:

4 months

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

January 2010

Completion Date:

January 2015

Related Keywords:

  • Lung Cancer
  • Exercise Intervention
  • Lung Cancer
  • Lung Neoplasms



Duke University Medical Center Durham, North Carolina  27710