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NCT Number: NCT06037902

CPAP for Esophageal Cancer With 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

Recruiting

Interested in participating?

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP

Device

patients undergo simulation twice, with and without CPAP

Primary outcomes

  1. absolute mean heart radiation dose

    Time frame: on day of simulation (day 1)

    measured in Gy

Secondary outcomes

  1. lung dose in Gy

    Time frame: on day of simulation (day 1)

    mean lung dose, V5 and V20

  2. heart dose in Gy

    Time frame: on day of simulation (day 1)

    mean heart dose, V30

  3. movement of tumor in cm

    Time frame: on day of simulation (day 1)

    how much tumor moves with breathing

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

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

Acronym: TROS-7

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 14, 2023
Registry last updated
Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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