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Recruiting NCT06037902

CPAP for Esophageal Cancer With Radiotherapy

No phase Interventional Esophageal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CPAP.
Who it may be relevant to
Registry conditions: Esophageal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • absolute mean heart radiation dose [Time frame: on day of simulation (day 1)]
Secondary outcome measures (3)
  • lung dose in Gy [Time frame: on day of simulation (day 1)]
  • heart dose in Gy [Time frame: on day of simulation (day 1)]
  • movement of tumor in cm [Time frame: on day of simulation (day 1)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Israel · 1 center
  • Sheba Medical Center — Ramat Gan

Identifiers

NCT: NCT06037902 · SHEBA-22-0032-YL-CTIL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗