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Sponsors and Collaborators: |
Duke University Lance Armstrong Foundation |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00636571 |
Primary Objective: To examine the effects of an exercise training program on cardiopulmonary fitness in early-stage postoperative non-small cell lung cancer patients undergoing adjuvant chemotherapy
Secondary Objectives:
Determine patients' adherence levels to such a program during adjuvant chemotherapy Explore the effects of exercise training on treatment compliance and toxicity, and quality of life.
To explore the effects of exercise training on markers of inflammation (e.g., c-reactive protein, immune response) in patients undergoing adjuvant chemotherapy for early-stage non-small cell lung cancer
Condition | Intervention |
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Non-Small Cell Lung Cancer |
Behavioral: Exercise |
Study Type: | Interventional |
Study Design: | Supportive Care, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Determining the Feasibility of Post-Operative Training for Patients Diagnosed With Non-Small Cell Lung Cancer |
Estimated Enrollment: | 23 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | March 2008 |
Estimated Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Exercise treatment Arm
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Behavioral: Exercise
Exercise
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Using a single-group, prospective design, potential participants will be identified and screened for eligibility by the PI (LWJ) via medical record review of patients scheduled for their primary adjuvant chemotherapy consultation at DUMC and Durham VA. As a routine part of clinical care, during the treatment consultation the attending oncologist will perform a physical examination to screen for cardiovascular risk factors, the results of which will be recorded in the patients' medical records. Immediately following their consultation and oncologist approval, potential participants will be provided with a thorough review of the study by the principal investigator (LJ) and asked if they are willing to participate. Interested participants will be given an information package that provides further information on study participation. Two to five days following their treatment consultation and prior to the initiation of chemotherapy, interested participants will be contacted by telephone by the PI to answer any questions and to schedule the baseline assessment visit. At the baseline visit, participants will be asked to sign the informed consent and will be given a copy for their records. After consent, they will be given a baseline ECG and physician monitored cardiopulmonary exercise test (stress test) to screen for undiagnosed cardiovascular disease. Following the successful completion of baseline assessments, all participants will be scheduled for their initial exercise training session.
Finally, on a different group of patients we will perform a random retrospective medical chart review of 50 completely-resected NSCLC patients who received usual care (i.e., no exercise training) during the study period to obtain comparative information on the treatment toxicity/compliance rate. The chart review will be performed by Drs. Jones, Garst and Crawford and will assess treatment toxicity and compliance over the entire course of adjuvant chemotherapy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Duke University Health System Preston Robert Tisch Brain Tumor Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Lee Jones, PhD | Duke University Health System |
Responsible Party: | Duke University Health Systems ( Lee Jones, PhD ) |
Study ID Numbers: | 8257 |
Study First Received: | February 27, 2008 |
Last Updated: | March 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00636571 History of Changes |
Health Authority: | United States: Institutional Review Board |
Exercise Non-Small Cell Lung Cancer Cardiopulmonary Fitness |
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |