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CPAP Devices for Breast and Lung Cancer
N/A
Recruiting
Led By Sheeh Cherian, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be undergoing left breast/chest wall radiation with or without regional nodal irradiation
Patients with left-sided breast cancers
Must not have
Patients with right side breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time of scan, " day 1"
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether using a CPAP device can help improve outcomes for patients with left-sided breast cancer or lung SBRT.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While this trial focuses on data collection rather than drug effects, using a CPAP device may cause discomfort, difficulty sleeping, dry mouth or nose, and possible skin irritation where the mask contacts the face.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am receiving radiation therapy on my left breast or chest wall, possibly including nearby lymph nodes.
Select...
My breast cancer is in the left breast.
Select...
I am receiving targeted radiation therapy for my lung.
Select...
My cancer has spread to my lungs.
Select...
My cancer originated in my lungs.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My breast cancer is in the right breast.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the time of scan, " day 1"
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the time of scan, " day 1"
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dosimetry comparison CPAP and free breathing.
Secondary study objectives
Cardiac dosimetry with CPAP as compared to free breathing
Confirm maintenance of inflation with CPAP using surface guidance
Measure breast/chest wall or lung tumor motion as well as organ at risk motion
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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 Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
468 Previous Clinical Trials
33,346 Total Patients Enrolled
Varian Medical SystemsIndustry Sponsor
62 Previous Clinical Trials
3,703 Total Patients Enrolled
Sheeh Cherian, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer originated in my lungs.I am receiving radiation therapy on my left breast or chest wall, possibly including nearby lymph nodes.My breast cancer is in the right breast.I am receiving targeted radiation therapy for my lung.My breast cancer is in the left breast.My cancer has spread to my lungs.You cannot use the CPAP machine without difficulty.
Research Study Groups:
This trial has the following groups:- Group 1: Lung SBRT
- Group 2: left-sided breast cancer
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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