CPAP Devices for Breast and Lung Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Case Comprehensive Cancer Center
Disqualifiers: Right side breast cancer, CPAP intolerance
No Placebo Group
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.
12345How 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.
12467Eligibility 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.
+2 more
Exclusion Criteria
My breast cancer is in the right breast.
You cannot use the CPAP machine without difficulty.
Trial 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
Participant Groups
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.
2Treatment groups
Active Control
Group I: Lung SBRTActive Control3 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 cancerActive Control3 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, OH
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Who Is Running the Clinical Trial?
Case Comprehensive Cancer CenterLead Sponsor
Varian Medical SystemsIndustry Sponsor
References
Nursing postoperative lung cancer patients using continuous positive airway pressure treatment. [2021]This study aimed to investigate the nursing of postoperative lung cancer patients treated with continuous positive airway pressure (CPAP).
Cancer risk in patients with sleep apnoea following adherent 5-year CPAP therapy. [2022]Increasing evidence suggests that obstructive sleep apnoea (OSA) contributes to cancer risk; however, limited data are available on the impact of continuous positive airway pressure (CPAP) therapy on cancer incidence. We aimed to determine whether adherence to CPAP therapy is associated with a reduction in all-cancer incidence compared with nonadherent patients with OSA.
Severe Obstructive Sleep Apnea Associated With Higher Risk of Mortality in Stage III and IV Lung Cancer. [2020]Obstructive sleep apnea (OSA) has been associated with increased cancer incidence and mortality. The aim of this study was to investigate cancer-related mortality, overall survival and progression free survival in patients with suspected OSA and lung cancer.
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]More information is needed about the effect on mortality of continuous positive airway pressure (CPAP) in patients with obstructive sleep apnea (OSA), especially in women.
Prognostic value of lung function and pulmonary haemodynamics in OSA patients treated with CPAP. [2019]The aim of the present study was to determine survival rates of obstructive sleep apnoea patients treated with continuous positive airway pressure (CPAP) and to investigate the prognostic value of pretreatment lung function and pulmonary haemodynamics. Two hundred and ninety-six patients, exhibiting > or = 20 apnoeas plus hypopnoeas per hour of sleep, were included. Patients were treated with nasal CPAP and regularly followed up. The cumulative survival rates were 0.96 (95% confidence interval (CI): 0.94-0.99) at 3 yrs and 0.93 (95% CI: 0.91-0.97) at 5 yrs. Most patients died from cardiovascular disease. Apart from age, covariates associated with a lower survival were the presence of a heavy smoking history, a low vital capacity, a low forced expiratory volume in one second (FEV1) and a high mean pulmonary artery pressure. Only three covariates were included by forward stepwise selection in the multivariate analysis, smoking habit (>30 pack-yrs), age and FEV1. The observed survival rates of the group as a whole were similar to those of the general population matched in terms of age, sex and smoking habit, except for patients between 50 and 60 yrs old who had reduced survival. This difference disappeared when patients of the present study with an associated chronic obstructive pulmonary disease were excluded from the comparison. In conclusion, survival of obstructive sleep apnoea patients treated with nasal continuous positive airway pressure is near to that of the general population. The prognosis is worse in subgroups of patients with a history of heavy smoking and with an associated chronic obstructive pulmonary disease.
Longitudinal Analysis of Causes of Mortality in Continuous Positive Airway Pressure-treated Patients at the Population Level. [2021]Rationale: Randomized controlled trials do not support a role for continuous positive airway pressure (CPAP) in preventing major cardiovascular events or mortality in patients with obstructive sleep apnea (OSA). However, these trials' setting does not apply to most CPAP-treated patients. Objectives: We aimed to assess the effect of CPAP on mortality in real-world patients. Methods: We performed a population-based longitudinal observational study including all patients with OSA prescribed CPAP during 2011 in Catalonia, Spain, and non-OSA control subjects matched (1:2) by sex, 5-year age group, and region who were followed from 2011 to 2016. Results: A total of 9,317 CPAP-treated patients with OSA and 18,370 control subjects without OSA were included (median age, 67 [57-72] years; 74% male). During a median follow-up of 5.5 years, 2,301 deaths were recorded. After adjustment by a composite of diagnosed comorbidities and previous use of healthcare resources, CPAP-treated patients showed a lower risk of death than control subjects (hazard ratio [HR], 0.67; 95% confidence interval [CI], 0.61-0.74), with the association not being statistically significant in women. Cancer-related deaths were the main drivers of this association (men: HR, 0.44; 95% CI, 0.36-0.54; women: HR, 0.44; 95% CI, 0.28-0.68). No significant associations were found for cardiovascular-related deaths. CPAP-treated women had an increased risk of respiratory-related death (HR, 2.41; 95% CI, 1.37-4.23). Conclusions: CPAP-treated patients had a lower mortality rate than control subjects. This relationship was driven by cancer-related, but not cardiovascular-related, deaths. Results suggest a role for sex when prescribing CPAP, especially considering respiratory-related deaths, and foster a debate on the relationship between OSA and cardiovascular outcomes.
A simple, lightweight CPAP-delivery device, composed of a three-way stopcock, for the nondependent lung. [2021]We aimed to introduce a simple, lightweight continuous positive airway pressure (CPAP)-delivery device for the nondependent lung during one-lung ventilation, to investigate how the type of three-way stopcocks, and the compliance and resistance of a test lung affect the relationship between the oxygen flow rate and CPAP level produced, and to examine how the device works in a clinical setting.