Exercise and Lung Cancer Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01068210
First received: February 11, 2010
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention
Lung Cancer
Behavioral: Exercise Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Phase III Trial of Exercise Training in Postsurgical Lung

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • To determine the effects of aerobic training and resistance training, relative to an attention-control group, on exercise capacity [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine the physiological mediators of the exercise training - exercise capacity relationship (e.g., skeletal muscle function as assessed by a muscle biopsy) [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: January 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerobic only
Supervised 3 times/week at ≥70% to 100% baseline cardiorespiratory fitness (VO2peak) for 16 weeks
Behavioral: Exercise Training
Subjects who have been diagnosed with lung cancer and are at least a year out from completing primary therapy
Experimental: Resistance Only
Supervised 3 resistance training sessions/week at an intensity above 60% to 80% of one-repetition maximum (1-RM) for 30-45 minutes/session for 16 weeks
Behavioral: Exercise Training
Subjects who have been diagnosed with lung cancer and are at least a year out from completing primary therapy
Experimental: Aerobic and Resistance
Supervised 3 times per week resistance training at an intensity above 60% to 80% of one-repetition maximum and aerobic at >70% to 100% of baseline cardiorespiratory fitness for 16 weeks
Behavioral: Exercise Training
Subjects who have been diagnosed with lung cancer and are at least a year out from completing primary therapy
No Intervention: Attention Control
Supervised 3 stretching sessions/week for 30-45 minutes/session for 16 weeks. All stretching sessions will be a total of 30-45 minutes in duration

Detailed Description:

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 samples.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068210

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01068210     History of Changes
Other Study ID Numbers: Pro00018255, 1R01CA138624-01A1
Study First Received: February 11, 2010
Last Updated: October 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Exercise Intervention
Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 19, 2014