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Feasibility of Exercise With Post-Op Lung Cancer Patients

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Non-Small Cell Lung Cancer focused on measuring Exercise, Non-Small Cell Lung Cancer, Cardiopulmonary Fitness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke University Health System Preston Robert Tisch Brain Tumor Center

Outcomes

Primary Outcome Measures

ECG stress test

Secondary Outcome Measures

Safety
adherence levels
The study will determine patients' adherence levels to such a program during adjuvant chemotherapy.
Treatment compliance and toxicity, and quality of life
The study will explore the effects of exercise training on treatment compliance and toxicity, and quality of life.
Inflammation
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.

Full Information

First Posted
February 27, 2008
Last Updated
October 25, 2013
Sponsor
Duke University
Collaborators
Lance Armstrong Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00636571
Brief Title
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

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Lance Armstrong Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Exercise, Non-Small Cell Lung Cancer, Cardiopulmonary Fitness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Upright bike intervention for post-surgical lung cancer survivors.
Primary Outcome Measure Information:
Title
ECG stress test
Time Frame
8 weeks, 16 weeks
Secondary Outcome Measure Information:
Title
Safety
Time Frame
8 weeks, 16 weeks
Title
adherence levels
Description
The study will determine patients' adherence levels to such a program during adjuvant chemotherapy.
Time Frame
8 and 16 weeks
Title
Treatment compliance and toxicity, and quality of life
Description
The study will explore the effects of exercise training on treatment compliance and toxicity, and quality of life.
Time Frame
8 and 16 weeks
Title
Inflammation
Description
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.
Time Frame
8 and 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Jones, PhD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Health System Preston Robert Tisch Brain Tumor Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Feasibility of Exercise With Post-Op Lung Cancer Patients

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