CPAP for Esophageal Cancer With Radiotherapy

Not Applicable

Recruiting

• Conditions: Esophageal Cancer
• Interventions: Device: CPAP

• Registration Number: NCT06037902
• Lead Sponsor: Sheba Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study Start: 2023-08-21
• Study First Submitted: 2023-08-28
• Study First Submitted QC: 2023-09-13
• Last Update Submitted: 2023-09-13
• Study First Posted: 2023-09-14
• Last Update Posted: 2023-09-14
• Primary Completion: 2027-09-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. Diagnosis of cancer, with a tumor (primary or secondary) in the esophagus including tumors in the esophagus-stomach junction.
2. Age ≥ 18
3. Planned RT treatment
4. The level of functioning ≥ 60 on the Karnofsky scale
5. Life expectancy ≥ two months
6. 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.
7. Able to undergo simulation and radiation with CPAP
8. 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:

1. Pregnancy or breastfeeding
2. Significant comorbidity at the starting point that would prevent the use of CPAP
3. Hospitalized in an institution by virtue of an administrative order or a court order.
4. Special population
5. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CPAP	CPAP	patients will undergo simulation twice, with and without CPAP

Primary Outcome Measures

Name	Time	Method
absolute mean heart radiation dose	on day of simulation (day 1)	measured in Gy

Secondary Outcome Measures

Name	Time	Method
heart dose in Gy	on day of simulation (day 1)	mean heart dose, V30
lung dose in Gy	on day of simulation (day 1)	mean lung dose, V5 and V20
movement of tumor in cm	on day of simulation (day 1)	how much tumor moves with breathing

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel