Incentive Spirometry for Lung Cancer

(INSPIRE-CRT Trial)

Overseen By Veli Bakalov, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cooper Health System

Must not be taking: Amiodarone, Bleomycin, Immunotherapy

Disqualifiers: Previous lung surgery, Home oxygen, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6-8 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if using an incentive spirometer can reduce lung problems in people with advanced lung cancer who are receiving chemotherapy and radiation therapy. The main questions the study aims to answer are: Does using an incentive spirometer lower the chances of developing lung inflammation (pneumonitis)? Does it improve overall survival and quality of life? Participants will: Use an incentive spirometer, a device that helps with deep breathing, 10 times every hour while awake. Continue using the spirometer daily during treatment and for up to three months after treatment. Complete quality of life assessments at the start of the study and at 3, 6, and 12 months. Researchers will compare the results to see if the incentive spirometer helps reduce lung problems and improves participants\' well-being during and after their cancer treatment.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Incentive Spirometry for lung cancer?

Incentive spirometry is often used after thoracic surgery to help with lung recovery, and while it hasn't shown clear benefits for all patients, it may help those at higher risk, like people with COPD, by reducing complications. It's a simple and affordable way to encourage regular breathing exercises, which can be beneficial for recovery. ^{1 2 3 4 5}

Is incentive spirometry safe for humans?

Incentive spirometry is generally considered safe for humans and is commonly used to help prevent lung complications after surgeries, such as lung or heart surgery, and in conditions like COPD (a lung disease). It is a mechanical device that encourages deep breathing to expand the lungs, and while its effectiveness can vary, it is a low-risk intervention. ^{3 4 6 7 8}

How does incentive spirometry differ from other treatments for lung cancer?

Incentive spirometry is a mechanical device that encourages deep breathing to expand the lungs, which is different from other treatments for lung cancer that may involve surgery, chemotherapy, or radiation. It is unique because it focuses on improving lung function and reducing complications by promoting lung expansion, rather than directly targeting cancer cells. ^{1 2 5 8 9}

Eligibility Criteria

This trial is for adults over 18 with advanced non-small-cell lung cancer who are fit enough (ECOG performance status 0-1) to undergo chemotherapy and radiation. It's not suitable for those outside these criteria.

Inclusion Criteria

I have been diagnosed with advanced non-small-cell lung cancer.

I am fully active or can carry out light work.

I am eligible for both chemotherapy and radiation at the same time.

Exclusion Criteria

I have ongoing issues with nausea and vomiting that aren't managed.

Enrollment in another pulmonary intervention trial

Home oxygen usage prior to enrolment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive concurrent chemotherapy and radiation therapy while using an incentive spirometer 10 times every hour while awake

6-8 weeks

Weekly visits for treatment and monitoring

Post-treatment Spirometry

Continued use of the incentive spirometer for up to three months post-treatment

12 weeks

Monthly check-ins for adherence and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessments and pulmonary function tests

12 months

Assessments at 3, 6, and 12 months post-treatment

Treatment Details

Interventions

• Incentive Spirometry

Trial Overview The study tests if an incentive spirometer, a device used to encourage deep breathing, can reduce lung complications and improve quality of life in patients receiving chemo and radiation therapy for advanced lung cancer.

Participant Groups

Group I: Intervention Arm Experimental Treatment 1 Intervention

The study will have one intervention group of patients using incentive spirometry in addition to standard of care treatment, including chemo/radiation and immunotherapy maintenance. For research purposes, patients will be asked to use incentive spirometry. Patients will use the incentive spirometer 10 times (10 breaths) every hour they are awake. Patients will be asked to start using the incentive spirometer as soon as they are enrolled in the study. Patients will be asked to continue to use incentive spirometry daily, including the duration of chemoradiation and up to three months post-treatment. Patients will be asked to to complete QoL assessments.

Who Is Running the Clinical Trial?

The Cooper Health System

Lead Sponsor

Trials

82

Recruited

35,600+

The Cooper Foundation

Collaborator

Trials

1

Recruited

100+

Findings from Research

In a randomized controlled trial involving 30 COPD patients, both incentive spirometry and inspiratory resistive muscle training (IMT) significantly improved respiratory function over 4 weeks, indicating their efficacy in pulmonary rehabilitation.

While IMT showed greater effectiveness in improving maximum voluntary ventilation (MVV) and inspiratory pressure (PImax), incentive spirometry was more effective in enhancing peak expiratory flow rate (PEFR), suggesting that both techniques have unique benefits for COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Inspiratory Resistive Muscle Training with Incentive Spirometry on Rehabilitation of COPD Patients. Heydari, A., Farzad, M., Ahmadi hosseini, SH.[2022]

Incentive spirometry is a useful tool for assessing lung function and respiratory recovery in patients after thoracic surgery, based on a review of seven key studies.

While incentive spirometry can aid in monitoring recovery, it does not replace the need for regular physiotherapy, which is more effective in reducing postoperative complications and improving lung function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is incentive spirometry effective following thoracic surgery? Agostini, P., Calvert, R., Subramanian, H., et al.[2008]

Incentive spirometry, commonly used after thoracic surgery, has not shown clear clinical benefits in reducing postoperative pulmonary complications or hospital stays for the general thoracic surgical patient population.

However, emerging evidence suggests that it may be beneficial for higher-risk patients, such as those with COPD, in reducing postoperative complications, despite challenges with patient adherence to the prescribed use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incentive Spirometry for Prevention of Postoperative Pulmonary Complications After Thoracic Surgery. Kotta, PA., Ali, JM.[2023]

In a study involving 387 adults undergoing lung resection, the addition of incentive spirometry (IS) to routine physiotherapy did not significantly reduce the incidence of postoperative pulmonary complications (PPC) compared to physiotherapy alone, with rates of PPC being 12.3% in the IS group and 13.0% in the control group.

The trial found no differences in secondary outcomes such as pneumonia rates, mechanical ventilation needs, or hospital length of stay, indicating that IS may not provide additional benefits in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incentive Spirometry After Lung Resection: A Randomized Controlled Trial. Malik, PRA., Fahim, C., Vernon, J., et al.[2022]

In a study of 7549 lung cancer patients undergoing video-assisted thoracic surgery (VATS), the use of incentive spirometry (IS) significantly reduced hospitalization costs by an average of $524.50 and decreased the risk of pneumonia (odds ratio of 0.55) compared to those not using IS.

While IS was more commonly used in patients undergoing thoracotomy (68.4%) than in those undergoing VATS (53.1%), it did not lead to differences in emergency department visits or hospitalizations at 3, 6, or 12 months post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is incentive spirometry beneficial for patients with lung cancer receiving video-assisted thoracic surgery? Liu, CJ., Tsai, WC., Chu, CC., et al.[2020]

In a systematic review of 592 participants from seven studies, incentive spirometry (IS) showed no significant difference in preventing postoperative pulmonary complications compared to other physiotherapy methods in adults undergoing coronary artery bypass graft (CABG).

Patients using IS actually experienced worse pulmonary function and arterial oxygenation than those receiving positive pressure breathing techniques, indicating that IS may not be beneficial and could potentially have negative effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incentive spirometry for preventing pulmonary complications after coronary artery bypass graft. Freitas, ER., Soares, BG., Cardoso, JR., et al.[2023]

In a study of 27 patients with COPD, those using incentive spirometry (IS) for 2 months showed significant improvements in arterial blood gases and health-related quality of life, as measured by the St. George's Respiratory Questionnaire.

The IS treatment group experienced better outcomes in dyspnoea and quality of life, while the medical treatment group showed no significant changes, indicating that IS may be beneficial in managing COPD exacerbations despite not affecting pulmonary function directly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of incentive spirometry in patients with COPD. Basoglu, OK., Atasever, A., Bacakoglu, F.[2015]

In a study of 50 adult patients with rib fractures, the use of an incentive spirometer (IS) significantly reduced the rate of pulmonary complications, with only 29.2% of the IS group experiencing complications compared to 80.7% in the control group.

Patients using the IS also showed significant improvements in lung function, as measured by forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1), indicating that the IS is an effective and safe intervention for enhancing recovery in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using an incentive spirometer reduces pulmonary complications in patients with traumatic rib fractures: a randomized controlled trial. Sum, SK., Peng, YC., Yin, SY., et al.[2020]

Incentive spirometry did not show any significant benefits in improving pulmonary function compared to other deep breathing and coughing exercises for patients at low risk of pulmonary complications.

The use of incentive spirometers may not be cost-effective, as patients were equally compliant with structured breathing exercises without the need for a technical device to motivate them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of incentive spirometers in post-operative protocols for low-risk patients. Davies, BL., MacLeod, JP., Ogilvie, HM.[2007]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparing Inspiratory Resistive Muscle Training with Incentive Spirometry on Rehabilitation of COPD Patients. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Is incentive spirometry effective following thoracic surgery? [2008]

3. United States pubmed.ncbi.nlm.nih.gov

Incentive Spirometry for Prevention of Postoperative Pulmonary Complications After Thoracic Surgery. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Incentive Spirometry After Lung Resection: A Randomized Controlled Trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Is incentive spirometry beneficial for patients with lung cancer receiving video-assisted thoracic surgery? [2020]

6. England pubmed.ncbi.nlm.nih.gov

Incentive spirometry for preventing pulmonary complications after coronary artery bypass graft. [2023]

7. Australia pubmed.ncbi.nlm.nih.gov

The efficacy of incentive spirometry in patients with COPD. [2015]

8. England pubmed.ncbi.nlm.nih.gov

Using an incentive spirometer reduces pulmonary complications in patients with traumatic rib fractures: a randomized controlled trial. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

The efficacy of incentive spirometers in post-operative protocols for low-risk patients. [2007]