Non-Small Cell Lung CancerNCT00636571
Feasibility of Exercise With Post-Op Lung Cancer Patients
A study testing Exercise in people with Non-Small Cell Lung Cancer, run by Duke University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Acute myocardial infarction (3-5 days)
- Unstable angina
- Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
- Syncope
- Acute endocarditis
- Acute myocarditis or pericarditis
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System Preston Robert Tisch Brain Tumor Center
Durham, North Carolina, 27710
About this study
Official title: 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
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Exercise
- Keywords
- Exercise, Non-Small Cell Lung Cancer, Cardiopulmonary Fitness
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Upright bike intervention for post-surgical lung cancer survivors.
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG stress test
Measured: 8 weeks, 16 weeks
Secondary outcomes (4)
Safety
Measured: 8 weeks, 16 weeks
adherence levels
The study will determine patients' adherence levels to such a program during adjuvant chemotherapy.
Measured: 8 and 16 weeks
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.
Measured: 8 and 16 weeks
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.
Measured: 8 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startMar 2006
- Primary completionSep 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Lance Armstrong Foundation
- Responsible party
- Sponsor
- Investigators
- Lee Jones, PhD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636571
- Sponsor's protocol ID
- Pro00005438
- Status last verified
- Oct 2013
- First submitted
- 27 Feb 2008
- Last updated
- 28 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Feasibility of Post-Operative Training for Patients Diagnosed With Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00636571
- Acronym / sponsor ID
- Pro00005438
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Exercise, Non-Small Cell Lung Cancer, Cardiopulmonary Fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Lance Armstrong Foundation
- Study start
- Mar 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- Acute myocardial infarction (3-5 days)
- Unstable angina
- Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
- Syncope
- Acute endocarditis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseUpright bike intervention for post-surgical lung cancer survivors. | Behavioural | – |
Primary outcome
ECG stress test
Time frame: 8 weeks, 16 weeks
4 secondary outcomes
Safety
Time frame: 8 weeks, 16 weeks
adherence levels
Time frame: 8 and 16 weeks
Treatment compliance and toxicity, and quality of life
Time frame: 8 and 16 weeks
Inflammation
Time frame: 8 and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Jones, PhD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Non-Small Cell Lung Cancer, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECG stress test (time frame: 8 weeks, 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2013.