CPAP for Esophageal Cancer With Radiotherapy (TROS-7)

Sheba Medical Center

Status: Enrolling

Conditions: Esophageal Cancer

Treatments: Device: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT06037902

SHEBA-22-0032-YL-CTIL

Details and patient eligibility

About

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

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

CPAP

Experimental group

Description:

patients will undergo simulation twice, with and without CPAP

Treatment:

Device: CPAP