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Determining the Feasibility of Post-Operative Training for Patients Diagnosed With Non-Small Cell Lung Cancer

18 Years
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Non-Small Cell Lung Cancer

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Trial Information

Determining the Feasibility of Post-Operative Training for Patients Diagnosed With Non-Small Cell Lung Cancer

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.

Inclusion Criteria:

- Legal age (>18 years old)

- Absence of contraindications to chemotherapy

- Ability to read and understand English

- Signed informed consent prior to the initiation of study procedures

- Primary attending oncologist approval.

Exclusion Criteria:

- 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.

- Finally, patients presenting with no medical history will not be eligible for study

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

ECG stress test

Outcome Time Frame:

8 weeks, 16 weeks

Safety Issue:


Principal Investigator

Lee Jones, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Health System


United States: Institutional Review Board

Study ID:




Start Date:

March 2006

Completion Date:

March 2008

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Exercise
  • Non-Small Cell Lung Cancer
  • Cardiopulmonary Fitness
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Duke University Health System Preston Robert Tisch Brain Tumor Center Durham, North Carolina  27710