CPAP for Esophageal Cancer With Radiotherapy | NCT06037902

Studies
CPAP for Esophageal Cancer With Radiotherapy

NCT06037902

Sponsor

Sheba Medical Center

Status

Recruiting

Last Update Posted

Sep 14, 2023Actual

Enrollment

44Estimated

Phase

Not Applicable

Conditions

Esophageal Cancer

Interventions

CPAP

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 21, 2023Actual

Primary Completion Date

Sep 30, 2027Estimated

Completion Date

Sep 30, 2027Estimated

First Submitted Date

Aug 28, 2023

First Submission Date that Met QC Criteria

Sep 13, 2023

First Posted Date

Sep 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2023

Last Update Posted Date

Sep 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CPAP	Experimental	patients will undergo simulation twice, with and without CPAP	Device: CPAP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CPAP	Device	patients undergo simulation twice, with and without CPAP	CPAP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
absolute mean heart radiation dose	measured in Gy	on day of simulation (day 1)

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center	Recruiting	Ramat Gan		52621	Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004938	Esophageal Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided