Feasibility of Exercise With Post-Op Lung Cancer Patients
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
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
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Determining the Feasibility of Post-Operative Training for Patients Diagnosed With Non-Small Cell Lung Cancer|
- ECG stress test [ Time Frame: 8 weeks, 16 weeks ] [ Designated as safety issue: No ]
- Safety [ Time Frame: 8 weeks, 16 weeks ] [ Designated as safety issue: Yes ]
- adherence levels [ Time Frame: 8 and 16 weeks ] [ Designated as safety issue: No ]The study will determine patients' adherence levels to such a program during adjuvant chemotherapy.
- Treatment compliance and toxicity, and quality of life [ Time Frame: 8 and 16 weeks ] [ Designated as safety issue: No ]The study will explore the effects of exercise training on treatment compliance and toxicity, and quality of life.
- Inflammation [ Time Frame: 8 and 16 weeks ] [ Designated as safety issue: No ]The study will 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.
|Study Start Date:||March 2006|
|Study Completion Date:||March 2008|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636571
|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|