Exercise and Lung Cancer Trial
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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 | Phase |
|---|---|---|
|
Lung Cancer |
Behavioral: Exercise Training |
Phase 3 |
| 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 |
- 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 ]
- 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 |
Inclusion Criteria:
- 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)
- At least 21 years old. Children are not diagnosed with lung cancer,
- An interval of at least 6 months following surgical resection,
- An interval of no longer than 24 months post-resection,
- Ability to read and understand English,
- Primary attending oncologist approval,
- 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),
- Willingness to be randomized,
- Signed informed consent prior to initiation of study-related procedures, and
- Reside within driving distance of DUMC, as necessitated by the clinic-based assessments and supervised exercise training interventions.
Exclusion Criteria:
- 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),
- Presence of metastatic disease,
- Scheduled to receive any form of adjuvant cancer therapy (i.e., radiation, chemotherapy, or any form of targeted therapy),
- Pregnancy,
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:
- acute myocardial infarction (3-5 days),
- unstable angina,
- uncontrolled arrhythmias causing symptoms or hemodynamic compromise,
- syncope,
- acute endocarditis,
- acute myocarditis or pericarditis,
- uncontrolled heart failure,
- acute pulmonary embolus or pulmonary infarction,
- thrombosis of lower extremities,
- suspected dissecting aneurysm,
- uncontrolled asthma,
- pulmonary edema,
- room air desaturation at rest ≤85%,
- respiratory failure,
- acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise,
- mental impairment leading to inability to cooperate, and
- extensive bone metastases.
Contacts and Locations| Contact: Lee Jones, PhD | 919-668-6791 | jones442@mc.duke.edu |
| Contact: Miranda West, BS | 919-681-5494 | miranda.west@duke.edu |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Lee Jones, PhD 919-668-6791 jones442@mc.duke.edu | |
| Contact: Miranda West, BS 919-681-5494 miranda.west@duke.edu | |
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: | November 6, 2012 |
| 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 June 17, 2013