Feasibility of Exercise With Post-Op Lung Cancer Patients

October 25, 2013 updated by: Duke University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ECG stress test
Time Frame: 8 weeks, 16 weeks
8 weeks, 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 8 weeks, 16 weeks
8 weeks, 16 weeks
adherence levels
Time Frame: 8 and 16 weeks
The study will determine patients' adherence levels to such a program during adjuvant chemotherapy.
8 and 16 weeks
Treatment compliance and toxicity, and quality of life
Time Frame: 8 and 16 weeks
The study will explore the effects of exercise training on treatment compliance and toxicity, and quality of life.
8 and 16 weeks
Inflammation
Time Frame: 8 and 16 weeks
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.
8 and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Lance Armstrong Foundation

Investigators

  • Principal Investigator: Lee Jones, PhD, Duke Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

February 27, 2008

First Submitted That Met QC Criteria

March 13, 2008

First Posted (Estimate)

March 14, 2008

Study Record Updates

Last Update Posted (Estimate)

October 28, 2013

Last Update Submitted That Met QC Criteria

October 25, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00005438

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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