search
Back to results

CPAP for Esophageal Cancer With Radiotherapy (TROS-7)

Primary Purpose

Esophageal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
CPAP
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring radiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CPAP

Arm Description

patients will undergo simulation twice, with and without CPAP

Outcomes

Primary Outcome Measures

absolute mean heart radiation dose
measured in Gy

Secondary Outcome Measures

lung dose in Gy
mean lung dose, V5 and V20
heart dose in Gy
mean heart dose, V30
movement of tumor in cm
how much tumor moves with breathing

Full Information

First Posted
August 28, 2023
Last Updated
September 13, 2023
Sponsor
Sheba Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT06037902
Brief Title
CPAP for Esophageal Cancer With Radiotherapy
Acronym
TROS-7
Official Title
Use of CPAP (Continuous Positive Airway Pressure) for Simulating Esophageal Cancer Patients Prior to Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2023 (Actual)
Primary Completion Date
September 30, 2027 (Anticipated)
Study Completion Date
September 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
radiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
all patients undergo two simulations.
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPAP
Arm Type
Experimental
Arm Description
patients will undergo simulation twice, with and without CPAP
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
patients undergo simulation twice, with and without CPAP
Primary Outcome Measure Information:
Title
absolute mean heart radiation dose
Description
measured in Gy
Time Frame
on day of simulation (day 1)
Secondary Outcome Measure Information:
Title
lung dose in Gy
Description
mean lung dose, V5 and V20
Time Frame
on day of simulation (day 1)
Title
heart dose in Gy
Description
mean heart dose, V30
Time Frame
on day of simulation (day 1)
Title
movement of tumor in cm
Description
how much tumor moves with breathing
Time Frame
on day of simulation (day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaacov R Lawrence, MBBS MA MRCP
Phone
97235304410
Email
Yaacov.Lawrence@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Aliza Ackerstein
Phone
035308402
Email
aliza.ackerstein@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Yaacov R Lawrence, MBBS MA MRCP

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

CPAP for Esophageal Cancer With Radiotherapy

We'll reach out to this number within 24 hrs