CachexiaNCT02017925
Pulmonary Rehabilitation in Improving Lung Function in Patients With Locally Advanced Non-Small Cell Lung Cancer Undergoing Chemoradiation
A study testing exercise intervention, pulmonary complications management/prevention and quality-of-life assessment in people with Cachexia and Fatigue, run by Ohio State University Comprehensive Cancer Center.
Trial summary
This randomized clinical trial studies pulmonary rehabilitation in improving lung function in patients with locally advanced non-small cell lung cancer undergoing chemoradiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia, Fatigue, Pulmonary Complications
- What is being tested?
- exercise intervention, pulmonary complications management/prevention and quality-of-life assessment
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Mar 2017
- 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
- Patients who have been diagnosed with locally advanced unresectable NSCLC undergoing definite chemo-radiation with curative intent
- Patients must be able to sign informed consent
- Patients who qualify for pulmonary rehabilitation as part of the standard of care and are covered by medical insurance
- Patients must be able to ambulate a minimum of 100 feet prior to enrollment in pulmonary rehab
- Patients must be willing and able to travel to the pulmonary rehabilitation site at the Morehouse Medical Plaza
Who cannot join
- Tumor resection candidates
- If survival is deemed less than 6 months for any medical condition
- If they have angina or unstable coronary disease
- Congestive heart failure refractory to medical management
- Malignancy with bone instability
- Inmates
About this study
Official title: Pulmonary Rehabilitation in Locally Advanced Non-Small Cell Lung Cancer
This randomized clinical trial studies pulmonary rehabilitation in improving lung function in patients with locally advanced non-small cell lung cancer undergoing chemoradiation. Individualized exercise rehabilitation programs may reduce breathing problems and improve quality of life in patients with non-small cell lung cancer. It is not yet known whether pulmonary rehabilitation is more effective when started during or after cancer treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine feasibility of pulmonary rehabilitation (PR) in patients with locally advanced unresectable non-small cell lung cancer (NSCLC) undergoing definite chemotherapy and radiation therapy.
II. To measure exercise capacity and respiratory symptoms in lung cancer patients receiving chemotherapy and radiation before and after pulmonary rehabilitation.
III. To compare if there are any differences in symptom relief, exercise capacity, and cancer treatment tolerability between performing pulmonary rehabilitation during chemo-radiation versus after completion of lung cancer treatment.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Beginning within 2 weeks of starting chemoradiation, patients undergo an individualized rehabilitation program comprising aerobic exercise and strength training, including treadmill walking, stationary bicycle, NU-Step, upper body resistance training and breathing retraining, 3 times per week for 8 weeks (36 sessions).
ARM II: Beginning 1 month after completion of chemoradiation, patients undergo an individualized exercise rehabilitation program as in Arm I.
- Conditions
- Cachexia, Fatigue, Pulmonary Complications, Radiation Toxicity, Recurrent Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer
- Being tested
- exercise intervention, pulmonary complications management/prevention, quality-of-life assessment, questionnaire administration
- Keywords
- Pulmonary Rehabilitation, Non-Small Cell Lung Cancer, NSCLC
- Medical subject headings
- Cachexia, Fatigue, Radiation Injuries, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise interventionBehavioural
Undergo pulmonary rehabilitation
pulmonary complications management/preventionProcedure or surgery
Undergo pulmonary rehabilitation
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (early intervention) | Experimental | Beginning within 2 weeks of starting chemoradiation, patients undergo an individualized rehabilitation program comprising aerobic exercise and strength training, including treadmill walking, stationary bicycle, NU-Step, upper body resistance training and breathing retraining, 3 times per week for 8 weeks (36 sessions). Receives: Behavioral: exercise intervention; Procedure: pulmonary complications management/prevention; Procedure: quality-of-life assessment; Other: questionnaire administration |
| Arm II (late intervention) | Experimental | Beginning 1 month after completion of chemoradiation, patients undergo an individualized exercise rehabilitation program as in Arm I. Receives: Behavioral: exercise intervention; Procedure: pulmonary complications management/prevention; Procedure: quality-of-life assessment; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent improvement in the 6 minute walk from prior to post PR
Either a two-sided t-test or a Wilcoxon-rank sum test will be used to test the difference in the improvement of the 6 minute walk depending on the distribution. This test will be used to compare the difference in improvement between PR during chemo-radiation of NSCLC patients and PR 8 weeks post chemo-radiation. Linear regression will be used to estimate which clinical characteristics and patient demographics are associated with improvement in 6 minute walk. The study population will be described using means and standard deviations or medians and the interquartile range.
Measured: Baseline to up to 8 weeks
Secondary outcomes (2)
Percent improvement in the St. George Respiratory Questionnaire (SGRQ) score
Measured: Baseline to up to 8 weeks
Feasibility of the program, based on number of patients attending the sessions throughout the 8 weeks
Either Pearson's chi-square of Fisher's exact methods will be used to test if the feasibility differs across groups. Logistic regression will be used to estimate which clinical characteristics and patient demographics are associated with feasibility.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CachexiaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Nana-Sinkam, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017925
- Sponsor's protocol ID
- OSU-13044
- Other IDs
- NCI-2013-02215
- Status last verified
- Apr 2017
- First submitted
- 17 Dec 2013
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Rehabilitation in Locally Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02017925
- Acronym / sponsor ID
- OSU-13044
- Conditions
- Cachexia, Fatigue, Pulmonary Complications, Radiation Toxicity, Recurrent Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer
- Keywords
- Pulmonary Rehabilitation, Non-Small Cell Lung Cancer, NSCLC
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 23 Dec 2013 (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.
This randomized clinical trial studies pulmonary rehabilitation in improving lung function in patients with locally advanced non-small cell lung cancer undergoing chemoradiation. Individualized exercise rehabilitation programs may reduce breathing problems and improve quality of life in patients with non-small cell lung cancer. It is not yet known whether pulmonary rehabilitation is more effective when started during or after cancer treatment.
Detailed description
PRIMARY OBJECTIVES:
- To determine feasibility of pulmonary rehabilitation (PR) in patients with locally advanced unresectable non-small cell lung cancer (NSCLC) undergoing definite chemotherapy and radiation therapy.
II. To measure exercise capacity and respiratory symptoms in lung cancer patients receiving chemotherapy and radiation before and after pulmonary rehabilitation.
III. To compare if there are any differences in symptom relief, exercise capacity, and cancer treatment tolerability between performing pulmonary rehabilitation during chemo-radiation versus after completion of lung cancer treatment.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Beginning within 2 weeks of starting chemoradiation, patients undergo an individualized rehabilitation program comprising aerobic exercise and strength training, including treadmill walking, stationary bicycle, NU-Step, upper body resistance training and breathing retraining, 3 times per week for 8 weeks (36 sessions).
ARM II: Beginning 1 month after completion of chemoradiation, patients undergo an individualized exercise rehabilitation program as in Arm I.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (early intervention) | Experimental | Behavioral: exercise intervention, Procedure: pulmonary complications management/prevention, Procedure: quality-of-life assessment, Other: questionnaire administrationBeginning within 2 weeks of starting chemoradiation, patients undergo an individualized rehabilitation program comprising aerobic exercise and strength training, including treadmill walking, stationary bicycle, NU-Step, upper body resistance training and breathing retraining, 3 times per week for 8 weeks (36 sessions). |
| Arm II (late intervention) | Experimental | Behavioral: exercise intervention, Procedure: pulmonary complications management/prevention, Procedure: quality-of-life assessment, Other: questionnaire administrationBeginning 1 month after completion of chemoradiation, patients undergo an individualized exercise rehabilitation program as in Arm I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who have been diagnosed with locally advanced unresectable NSCLC undergoing definite chemo-radiation with curative intent
- Patients must be able to sign informed consent
- Patients who qualify for pulmonary rehabilitation as part of the standard of care and are covered by medical insurance
- Patients must be able to ambulate a minimum of 100 feet prior to enrollment in pulmonary rehab
- Patients must be willing and able to travel to the pulmonary rehabilitation site at the Morehouse Medical Plaza
Key exclusion criteria (6 listed)
- Tumor resection candidates
- If survival is deemed less than 6 months for any medical condition
- If they have angina or unstable coronary disease
- Congestive heart failure refractory to medical management
- Malignancy with bone instability
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 |
|---|---|---|
| exercise interventionUndergo pulmonary rehabilitation | Behavioural | Arm I (early intervention), Arm II (late intervention) |
| pulmonary complications management/preventionUndergo pulmonary rehabilitation | Procedure or surgery | Arm I (early intervention), Arm II (late intervention) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I (early intervention), Arm II (late intervention) |
| questionnaire administrationAncillary studies | Other | Arm I (early intervention), Arm II (late intervention) |
Primary outcome
Percent improvement in the 6 minute walk from prior to post PR
Time frame: Baseline to up to 8 weeks
Either a two-sided t-test or a Wilcoxon-rank sum test will be used to test the difference in the improvement of the 6 minute walk depending on the distribution. This test will be used to compare the difference in improvement between PR during chemo-radiation of NSCLC patients and PR 8 weeks post chemo-radiation. Linear regression will be used to estimate which clinical characteristics and patient demographics are associated with improvement in 6 minute walk. The study population will be described using means and standard deviations or medians and the interquartile range.
2 secondary outcomes
Percent improvement in the St. George Respiratory Questionnaire (SGRQ) score
Time frame: Baseline to up to 8 weeks
Feasibility of the program, based on number of patients attending the sessions throughout the 8 weeks
Time frame: Up to 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- The JameslineLink provided by the sponsor.
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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.
Patrick Nana-Sinkam, MD principal investigator
Ohio State University Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing exercise intervention, pulmonary complications management/prevention and quality-of-life assessment in people with Cachexia and Fatigue, run by Ohio State University Comprehensive Cancer Center.
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 6 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: withdrawn, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Percent improvement in the 6 minute walk from prior to post PR (time frame: Baseline to up to 8 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 13 Apr 2017.