CPAP for Esophageal Cancer With Radiotherapy

Study Overview
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Brief Summary
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The goal of this clinical trial is to test the use of CPAP in patients with esophgaeal cancer undergoing radiotherapy. The main questions it aims to answer are: does use of CPAP decrease exposure of normal lung to radiation? does use of CPAP decrease exposure of normal heart to radiation? Participants will undergo simulation twice: with CPAP without CPAP

Official Title
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Use of CPAP (Continuous Positive Airway Pressure) for Simulating Esophageal Cancer Patients Prior to Radiotherapy

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Device: CPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cancer, with a tumor (primary or secondary) in the esophagus including tumors in the esophagus-stomach junction. Age ≥ 18 Planned RT treatment The level of functioning ≥ 60 on the Karnofsky scale Life expectancy ≥ two months All patients must understand the informed consent form document and sign it of their own free will before any test/procedure related to the study is performed. Able to undergo simulation and radiation with CPAP Candidate patients can be recruited to receive definitive, palliative or pre-operative radiation, with or without chemotherapy. Exclusion Criteria: A person who meets any of the following exclusion criteria will not be able to participate in the study: Pregnancy or breastfeeding Significant comorbidity at the starting point that would prevent the use of CPAP Hospitalized in an institution by virtue of an administrative order or a court order. Special population A history of a psychiatric problem that may impair the patient's ability to understand the research requirements or respond to them, or to give his consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: all patients undergo two simulations.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP<br>patients will undergo simulation twice, with and without CPAP | Device: CPAP<br>* patients undergo simulation twice, with and without CPAP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| absolute mean heart radiation dose | measured in Gy | on day of simulation (day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung dose in Gy | mean lung dose, V5 and V20 | on day of simulation (day 1) | 
| heart dose in Gy | mean heart dose, V30 | on day of simulation (day 1) | 
| movement of tumor in cm | how much tumor moves with breathing | on day of simulation (day 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiation