Skip to main content
OpenTrials
Completed

NCT Number: NCT00636571

Feasibility of Exercise With Post-Op Lung Cancer Patients

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Health System Preston Robert Tisch Brain Tumor Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Behavioral

Upright bike intervention for post-surgical lung cancer survivors.

Primary outcomes

  1. ECG stress test

    Time frame: 8 weeks, 16 weeks

Secondary outcomes

  1. Safety

    Time frame: 8 weeks, 16 weeks

  2. adherence levels

    Time frame: 8 and 16 weeks

    The study will determine patients' adherence levels to such a program during adjuvant chemotherapy.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Lance Armstrong Foundation

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Mar 14, 2008
Registry last updated
Oct 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.