Lung CancerNCT00363428
Lung Rehabilitation in Treating Patients With Chronic Obstructive Pulmonary Disease Who Are Undergoing Surgery for Lung Cancer
A study testing exercise intervention, smoking cessation intervention and counseling intervention in people with Lung Cancer and Perioperative/Postoperative Complications, run by Mayo Clinic at 1 site in United States.
Trial summary
RATIONALE: Exercise may help improve lung function and lessen complications of surgery in patients with chronic obstructive pulmonary disease who are undergoing surgery for lung cancer. Read more about this study
- Who is it for?
- Ages 40 to 120 years
- Conditions the study is for
- Lung Cancer, Perioperative/Postoperative Complications, Pulmonary Complications
- What is being tested?
- exercise intervention, smoking cessation intervention and counseling intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to 1 Nov 2012
- 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 40 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of lung cancer
- Scheduled to undergo any thoracotomy for lung cancer resection (including wedge) or VATS lobectomy or pneumonectomy for lung resection
- Diagnosis of COPD, meeting the following criteria:
- FEV_1/FVC < 0.71
- Smoking history ≥ 10 pack/years
- Presence of moderate to severe lung disease, meeting 1 of the following:
- FEV_1 ≤ 60% predicted*
- FEV_1< 80% predicted AND significant shortness of breath defined by a score of 2 or higher in the Medical Research Council Dyspnea Score NOTE: *Patients with an FEV1 < 60% predicted (most severe) and scheduled to undergo VATS segmentectomy or wedge resection will also be included.
PATIENT CHARACTERISTICS:
- Able to physically utilize exercise equipment as part of rehabilitation program
- No poor motivation or likely not to participate fully in PR program
- No recent history (within the past 3 months) of a clinically-significant myocardial infarction, unstable angina, serious cardiac arrhythmia, or other serious medical condition which the attending physician performing the preoperative evaluation deems incompatible with participation in the study
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Pulmonary Rehabilitation in Patients With Moderate to Severe COPD Who Require Lung Resection for Lung Cancer
RATIONALE: Exercise may help improve lung function and lessen complications of surgery in patients with chronic obstructive pulmonary disease who are undergoing surgery for lung cancer. It is not yet known whether lung rehabilitation is more effective than standard therapy in improving lung function in patients with chronic obstructive pulmonary disease who are undergoing surgery for lung cancer.
PURPOSE: This randomized clinical trial is studying lung rehabilitation to see how well it works compared to standard therapy in treating patients with chronic obstructive pulmonary disease who are undergoing surgery for lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare the impact of preoperative pulmonary rehabilitation (including upper and lower extremity resistance training) vs usual care in patients with lung cancer and moderate to severe chronic obstructive pulmonary disease who require lung resection for lung cancer.
- Compare the impact of this study intervention vs usual care on functional status after surgery.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 intervention arms.
- Arm I: Patients undergo pulmonary rehabilitation (including daily upper and lower extremity resistance training, education, and smoking cessation counseling) twice a day for 5 days prior to surgical resection. Beginning 2-3days after surgery, patients undergo pulmonary rehabilitation once a day until discharge from the hospital.
- Arm II: Patients receive usual care (education and smoking cessation counseling alone) twice a day for 5 days prior to surgical resection. Following surgery, patients will receive usual care once a day until discharge from the hospital.
Days of hospitalization, ICU admissions, postoperative complications (i.e., pneumonia, mechanical ventilation > 48 hours, or atelectasis requiring bronchoscopy) and spirometry and imaging studies will be evaluated after surgery.
After completion of study intervention, patients are followed at 4-6 weeks, at 12 weeks, and at 6 months.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.
- Conditions
- Lung Cancer, Perioperative/Postoperative Complications, Pulmonary Complications, Tobacco Use Disorder
- Being tested
- exercise intervention, smoking cessation intervention, counseling intervention, educational intervention, conventional surgery
- Keywords
- pulmonary complications, perioperative/postoperative complications, tobacco use disorder, non-small cell lung cancer, small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Postoperative Complications, Tobacco Use Disorder, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise interventionBehavioural
life style
smoking cessation interventionBehavioural
Life style
counseling interventionOther
life style
educational interventionOther
life style
conventional surgeryProcedure or surgery
life style
pulmonary complications management/preventionProcedure or surgery
life style
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Receive standard care and educational material on exercise and lifestyle choices of well-being Receives: Behavioral: exercise intervention; Behavioral: smoking cessation intervention; Other: counseling intervention; Other: educational intervention; Procedure: conventional surgery; Procedure: pulmonary complications management/prevention |
| Lifestyle intervention | Experimental | Not described Receives: Behavioral: exercise intervention; Behavioral: smoking cessation intervention; Other: counseling intervention; Other: educational intervention; Procedure: conventional surgery; Procedure: pulmonary complications management/prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay in hospital and functional status measured at 12 weeks post-operatively
Measured: 12 weeks
Secondary outcomes (6)
Hospital re-admission
Measured: 12 months
Oxygen requirement
Measured: 12 months
Post-operative pulmonary function
Measured: 12 months
Respiratory care interventions
Measured: 12 months
Number and percentage of patients with postoperative complications (defined as pneumonia, mechanical ventilation of more than 2 days, or atelectasis requiring a bronchoscopy)
Measured: 12 months
Measured physical activity at 6 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startAug 2006
- Primary completion1 Nov 2012
- Study completion1 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Roberto P. Benzo, MD, MS, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363428
- Sponsor's protocol ID
- MC0825
- Other IDs
- P30CA047904, K23CA106544, 08-007135, NCI-2009-01148, MC0825
- Status last verified
- Jul 2017
- First submitted
- 10 Aug 2006
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Perrotta F, Cennamo A, Cerqua FS, Stefanelli F, Bianco A, Musella S, Rispoli M, Salvi R, Meoli I. Effects of a high-intensity pulmonary rehabilitation program on the minute ventilation/carbon dioxide output slope during exercise in a cohort of patients with COPD undergoing lung resection for non-small cell lung cancer. J Bras Pneumol. 2019 Oct 14;45(6):e20180132. doi: 10.1590/1806-3713/e20180132. eCollection 2019.
PubMed 31618297
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Pulmonary Rehabilitation in Patients With Moderate to Severe COPD Who Require Lung Resection for Lung Cancer
- ClinicalTrials.gov ID
- NCT00363428
- Acronym / sponsor ID
- MC0825
- Conditions
- Lung Cancer, Perioperative/Postoperative Complications, Pulmonary Complications, Tobacco Use Disorder
- Keywords
- pulmonary complications, perioperative/postoperative complications, tobacco use disorder, non-small cell lung cancer, small cell lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2006 (actual)
- Primary completion
- 1 Nov 2012 (actual)
- Study completion
- 1 Nov 2012 (actual)
- First posted
- 15 Aug 2006 (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.
RATIONALE: Exercise may help improve lung function and lessen complications of surgery in patients with chronic obstructive pulmonary disease who are undergoing surgery for lung cancer. It is not yet known whether lung rehabilitation is more effective than standard therapy in improving lung function in patients with chronic obstructive pulmonary disease who are undergoing surgery for lung cancer.
PURPOSE: This randomized clinical trial is studying lung rehabilitation to see how well it works compared to standard therapy in treating patients with chronic obstructive pulmonary disease who are undergoing surgery for lung cancer.
Detailed description
OBJECTIVES:
Primary
- Compare the impact of preoperative pulmonary rehabilitation (including upper and lower extremity resistance training) vs usual care in patients with lung cancer and moderate to severe chronic obstructive pulmonary disease who require lung resection for lung cancer.
- Compare the impact of this study intervention vs usual care on functional status after surgery.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 intervention arms.
- Arm I: Patients undergo pulmonary rehabilitation (including daily upper and lower extremity resistance training, education, and smoking cessation counseling) twice a day for 5 days prior to surgical resection. Beginning 2-3days after surgery, patients undergo pulmonary rehabilitation once a day until discharge from the hospital.
- Arm II: Patients receive usual care (education and smoking cessation counseling alone) twice a day for 5 days prior to surgical resection. Following surgery, patients will receive usual care once a day until discharge from the hospital.
Days of hospitalization, ICU admissions, postoperative complications (i.e., pneumonia, mechanical ventilation > 48 hours, or atelectasis requiring bronchoscopy) and spirometry and imaging studies will be evaluated after surgery.
After completion of study intervention, patients are followed at 4-6 weeks, at 12 weeks, and at 6 months.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: exercise intervention, Behavioral: smoking cessation intervention, Other: counseling intervention, Other: educational intervention, Procedure: conventional surgery, Procedure: pulmonary complications management/preventionReceive standard care and educational material on exercise and lifestyle choices of well-being |
| Lifestyle intervention | Experimental | Behavioral: exercise intervention, Behavioral: smoking cessation intervention, Other: counseling intervention, Other: educational intervention, Procedure: conventional surgery, Procedure: pulmonary complications management/prevention |
Who may qualify
- Ages
- 40 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 interventionlife style | Behavioural | Control, Lifestyle intervention |
| smoking cessation interventionLife style | Behavioural | Control, Lifestyle intervention |
| counseling interventionlife style | Other | Control, Lifestyle intervention |
| educational interventionlife style | Other | Control, Lifestyle intervention |
| conventional surgerylife style | Procedure or surgery | Control, Lifestyle intervention |
| pulmonary complications management/preventionlife style | Procedure or surgery | Control, Lifestyle intervention |
Primary outcome
Length of stay in hospital and functional status measured at 12 weeks post-operatively
Time frame: 12 weeks
6 secondary outcomes
Hospital re-admission
Time frame: 12 months
Oxygen requirement
Time frame: 12 months
Post-operative pulmonary function
Time frame: 12 months
Respiratory care interventions
Time frame: 12 months
Number and percentage of patients with postoperative complications (defined as pneumonia, mechanical ventilation of more than 2 days, or atelectasis requiring a bronchoscopy)
Time frame: 12 months
Measured physical activity at 6 months
Time frame: 12 months
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 19 Jul 2017.
- Derived from this study: PubMed 31618297Perrotta F, Cennamo A, Cerqua FS, Stefanelli F, Bianco A, Musella S, Rispoli M, Salvi R, Meoli I. Effects of a high-intensity pulmonary rehabilitation program on the minute ventilation/carbon dioxide output slope during exercise in a cohort of patients with COPD undergoing lung resection for non-small cell lung cancer. J Bras Pneumol. 2019 Oct 14;45(6):e20180132. doi: 10.1590/1806-3713/e20180132. eCollection 2019.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Roberto P. Benzo, MD, MS study chair
Mayo Clinic
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 intervention, smoking cessation intervention and counseling intervention in people with Lung Cancer and Perioperative/Postoperative Complications, run by Mayo Clinic 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?
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 19 Jul 2017. 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. Some participants in this study may receive a placebo. 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?
Length of stay in hospital and functional status measured at 12 weeks post-operatively (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00363428, which also lists 1 linked publication.
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 19 Jul 2017.