Feasibility of Exercise With Post-Op Lung Cancer Patients

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636571
• Other study ID #: Pro00005438
• Status: Completed
• Phase: N/A
• First received: February 27, 2008
• Last updated: October 25, 2013
• Start date: March 2006
• Est. completion date: March 2008

Study information

• Verified date: October 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Behavioral:
• Exercise
Upright bike intervention for post-surgical lung cancer survivors.

Locations

Country	Name	City	State
United States	Duke University Health System Preston Robert Tisch Brain Tumor Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Lance Armstrong Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ECG stress test		8 weeks, 16 weeks	No
Secondary	Safety		8 weeks, 16 weeks	Yes
Secondary	adherence levels	The study will determine patients' adherence levels to such a program during adjuvant chemotherapy.	8 and 16 weeks	No
Secondary	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.	8 and 16 weeks	No
Secondary	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.	8 and 16 weeks	No