CPAP Devices for Breast and Lung Cancer

Overseen By Sheeh Cherian, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Right side breast cancer, CPAP intolerance

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

Compensation: Varies

Number of Visits: 1

8 Participants Needed

Trial Summary

What is the purpose of this trial?

Data collection and assessment on patients with left-sided breast cancer or undergoing lung stereotactic body radiation therapy (SBRT) utilizing continuous positive airway pressure (CPAP) devices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment CPAP Devices for Breast and Lung Cancer?

Research suggests that continuous positive airway pressure (CPAP) treatment can improve survival rates in patients with obstructive sleep apnea (OSA), which is linked to cancer risk. Adherence to CPAP therapy has been associated with a reduction in cancer incidence among patients with OSA. ^{1 2 3 4 5}

How does CPAP treatment differ from other treatments for breast and lung cancer?

CPAP (Continuous Positive Airway Pressure) is unique because it is primarily used to treat sleep apnea by keeping airways open during sleep, but it is being explored for its potential impact on cancer-related outcomes. Unlike traditional cancer treatments like chemotherapy or radiation, CPAP is a non-invasive device that provides a steady flow of air to maintain open airways, which may help reduce cancer-related mortality in patients with sleep apnea. ^{1 2 4 6 7}

Research Team

Sheeh Cherian, MD

Principal Investigator

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Eligibility Criteria

This trial is for patients with left-sided breast cancer or those undergoing lung SBRT, including cases of metastatic and primary lung cancers. It's not suitable for individuals with right-side breast cancer or those who cannot tolerate a CPAP device.

Inclusion Criteria

My cancer originated in my lungs.

I am receiving radiation therapy on my left breast or chest wall, possibly including nearby lymph nodes.

I am receiving targeted radiation therapy for my lung.

Exclusion Criteria

My breast cancer is in the right breast.

You cannot use the CPAP machine without difficulty.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Planning and Treatment

Participants undergo radiation planning and treatment with CPAP, including three scans (with and without DIBH, with CPAP).

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of lung and cardiac dosimetry.

4 weeks

Treatment Details

Interventions

• Continuous Positive Airway Pressure
• Deep inspiratory breath hold
• Free Breath

Trial Overview The study is evaluating the use of CPAP devices during radiation therapy to see if they can reduce the amount of radiation received by the lungs in patients with certain types of breast and lung cancers.

Participant Groups

Group I: Lung SBRT Active Control 3 Interventions

Participants will come in for their regularly scheduled radiation planning and treatment. Participants will undergo three scans (with and without DIBH (i.e., free-breathing), with CPAP). Participants will also use the CPAP device before the CT scan, for which they will be educated and trained.

Group II: left-sided breast cancer Active Control 3 Interventions

Participants will come in for their regularly scheduled radiation planning and treatment. Participants will undergo three scans (with and without DIBH (i.e., free-breathing), with CPAP). Participants will also use the CPAP device before the CT scan, for which they will be educated and trained.

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Varian Medical Systems

Industry Sponsor

Trials

63

Recruited

3,700+

Dow R. Wilson

Varian Medical Systems

Chief Executive Officer since 2012

MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University

Dr. Deepak Khuntia

Varian Medical Systems

Chief Medical Officer since 2020

MD from the University of Cambridge, PhD from the University of Leicester

Findings from Research

In a study of 64 postoperative lung cancer patients, those using continuous positive airway pressure (CPAP) showed significant improvements in blood gas analysis and airway patency compared to those receiving standard oxygen therapy.

One month after treatment, CPAP patients experienced fewer symptoms such as inappetence, weight loss, and dyspnea, and demonstrated better lung function metrics like higher maximum ventilatory volumes and peak expiratory flows, indicating its efficacy in enhancing recovery post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nursing postoperative lung cancer patients using continuous positive airway pressure treatment. Jiang, Q., Zheng, W., Chen, B.[2021]

In a study of 4,499 patients with obstructive sleep apnoea (OSA) followed for an average of 5.4 years, adherence to continuous positive airway pressure (CPAP) therapy did not significantly reduce the overall incidence of cancer compared to nonadherent patients.

Out of the participants, 10.7% of nonadherent patients developed cancer, while 9.1% of adherent patients did, indicating that CPAP adherence did not have a measurable impact on cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer risk in patients with sleep apnoea following adherent 5-year CPAP therapy. Justeau, G., Bailly, S., Gervès-Pinquié, C., et al.[2022]

In a study of 8261 patients with suspected obstructive sleep apnea (OSA), those with lung cancer had a significantly higher incidence of cancer compared to the general population, indicating a potential link between OSA and increased cancer risk.

The study found that cancer-related mortality in lung cancer patients increased with the severity of OSA, with a 3-year mortality rate of 80% for those with severe OSA (AHI ≥ 30), while patients with milder OSA (AHI < 30) had better overall and progression-free survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe Obstructive Sleep Apnea Associated With Higher Risk of Mortality in Stage III and IV Lung Cancer. Huang, HY., Shih-Wei, L., Chuang, LP., et al.[2020]

In a study of 25,389 patients with obstructive sleep apnea (OSA), continuous positive airway pressure (CPAP) treatment was linked to a significant reduction in all-cause mortality in middle-aged and elderly males, with a hazard ratio of 0.62 (P<0.001).

While CPAP improved survival rates in older males, it did not show a significant effect on mortality in female patients, indicating a gender difference in the efficacy of CPAP treatment for OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

All-cause mortality from obstructive sleep apnea in male and female patients with and without continuous positive airway pressure treatment: a registry study with 10 years of follow-up. Jennum, P., Tønnesen, P., Ibsen, R., et al.[2022]

Patients with obstructive sleep apnoea treated with continuous positive airway pressure (CPAP) have high survival rates, with 96% surviving at 3 years and 93% at 5 years, comparable to the general population.

Survival is negatively impacted by factors such as heavy smoking history, low lung function (measured by FEV1), and high pulmonary artery pressure, particularly in patients aged 50-60 years, especially those with chronic obstructive pulmonary disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic value of lung function and pulmonary haemodynamics in OSA patients treated with CPAP. Chaouat, A., Weitzenblum, E., Krieger, J., et al.[2019]

In a study of 9,317 patients with obstructive sleep apnea (OSA) treated with CPAP, there was a significant reduction in overall mortality compared to 18,370 matched control subjects, with a hazard ratio of 0.67, indicating a 33% lower risk of death.

The lower mortality rate in CPAP-treated patients was primarily linked to a reduction in cancer-related deaths, while no significant impact was observed on cardiovascular-related deaths, highlighting the need to consider sex differences in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal Analysis of Causes of Mortality in Continuous Positive Airway Pressure-treated Patients at the Population Level. de Batlle, J., Bertran, S., Turino, C., et al.[2021]

The lightweight CPAP delivery device effectively increases oxygen levels in patients during one-lung ventilation, with peripheral oxygen saturation improving while CPAP levels ranged from 2.8 to 5.4 cmH2O in a clinical study involving seven patients.

The device's CPAP output is directly proportional to the oxygen flow rate and is not affected by the compliance or resistance of the lung, allowing for predictable CPAP levels before clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A simple, lightweight CPAP-delivery device, composed of a three-way stopcock, for the nondependent lung. Sasano, H., Sasano, N., Ito, S., et al.[2021]

References

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

Nursing postoperative lung cancer patients using continuous positive airway pressure treatment. [2021]

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

Cancer risk in patients with sleep apnoea following adherent 5-year CPAP therapy. [2022]

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

Severe Obstructive Sleep Apnea Associated With Higher Risk of Mortality in Stage III and IV Lung Cancer. [2020]

4. New Zealand pubmed.ncbi.nlm.nih.gov

All-cause mortality from obstructive sleep apnea in male and female patients with and without continuous positive airway pressure treatment: a registry study with 10 years of follow-up. [2022]

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

Prognostic value of lung function and pulmonary haemodynamics in OSA patients treated with CPAP. [2019]

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

Longitudinal Analysis of Causes of Mortality in Continuous Positive Airway Pressure-treated Patients at the Population Level. [2021]

7. Japan pubmed.ncbi.nlm.nih.gov

A simple, lightweight CPAP-delivery device, composed of a three-way stopcock, for the nondependent lung. [2021]