Clinical trial NCT00636571: Feasibility of Exercise With Post-Op Lung Cancer Patients
Official title: Determining the Feasibility of Post-Operative Training for Patients Diagnosed With Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Small Cell Lung Cancer
Keywords: Exercise
Non-Small Cell Lung Cancer
Cardiopulmonary Fitness
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Lance Armstrong Foundation
First posted: 2008-03-14
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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 participation.

Primary outcomes:
measure: ECG stress test
timeFrame: 8 weeks, 16 weeks
Secondary outcomes:
measure: Safety
timeFrame: 8 weeks, 16 weeks
measure: adherence levels
timeFrame: 8 and 16 weeks
measure: Treatment compliance and toxicity, and quality of life
timeFrame: 8 and 16 weeks
measure: Inflammation
timeFrame: 8 and 16 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System Preston Robert Tisch Brain Tumor Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Lee Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References: