CPAP for Esophageal Cancer With Radiotherapy

Esophageal Cancer Clinical Trial

— TROS-7  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06037902
• Other study ID #: SHEBA-22-0032-YL-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: August 21, 2023
• Est. completion date: September 30, 2027

Study information

• Verified date: August 2023
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: September 30, 2027
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Device:
• CPAP
patients undergo simulation twice, with and without CPAP

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	absolute mean heart radiation dose	measured in Gy	on day of simulation (day 1)
Secondary	lung dose in Gy	mean lung dose, V5 and V20	on day of simulation (day 1)
Secondary	heart dose in Gy	mean heart dose, V30	on day of simulation (day 1)
Secondary	movement of tumor in cm	how much tumor moves with breathing	on day of simulation (day 1)