CPAP for Esophageal Cancer With Radiotherapy (TROS-7)

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

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

Study Overview

• Status: Recruiting
• Conditions: Esophageal Cancer
• Intervention / Treatment: Device: CPAP

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel, 52621
    • Recruiting
    • Sheba Medical Center
    • Contact: Yaacov R Lawrence, MBBS MA MRCP; Phone Number: 97235304410; Email: Yaacov.Lawrence@sheba.health.gov.il
    • Contact: Aliza Ackerstein; Phone Number: 035308402; Email: aliza.ackerstein@sheba.health.gov.il
    • Principal Investigator: Yaacov R Lawrence, MBBS MA MRCP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CPAP; patients will undergo simulation twice, with and without CPAP	Device: CPAP; patients undergo simulation twice, with and without CPAP

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: radiation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: SHEBA-22-0032-YL-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No