Feasibility of Exercise With Post-Op Lung Cancer Patients

This study has been completed.
Sponsor:
Collaborator:
Lance Armstrong Foundation
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00636571
First received: February 27, 2008
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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
Non-Small Cell Lung Cancer
Behavioral: Exercise

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • ECG stress test [ Time Frame: 8 weeks, 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Enrollment: 21
Study Start Date: March 2006
Study Completion Date: March 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Exercise
    Upright bike intervention for post-surgical lung cancer survivors.
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636571

Locations
United States, North Carolina
Duke University Health System Preston Robert Tisch Brain Tumor Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Lance Armstrong Foundation
Investigators
Principal Investigator: Lee Jones, PhD Duke University Health System
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00636571     History of Changes
Other Study ID Numbers: Pro00005438
Study First Received: February 27, 2008
Last Updated: October 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Exercise
Non-Small Cell Lung Cancer
Cardiopulmonary Fitness

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014