CPAP for Esophageal Cancer With Radiotherapy

NCT06037902 | Recruiting

• 1 other identifier: SHEBA-22-0032-YL-CTIL
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

Esophageal Cancer

Keywords

radiation

Outcome Measures

Primary Outcomes (1)

• absolute mean heart radiation dose

  measured in Gy

  on day of simulation (day 1)

Secondary Outcomes (3)

• lung dose in Gy

  on day of simulation (day 1)

• heart dose in Gy

  on day of simulation (day 1)

• movement of tumor in cm

  on day of simulation (day 1)

Study Arms (1)

CPAP

EXPERIMENTAL

patients will undergo simulation twice, with and without CPAP

Device: CPAP

Interventions

CPAP DEVICE

patients undergo simulation twice, with and without CPAP

CPAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Department of Radiation Oncology, principal investigator

Model Details: all patients undergo two simulations.

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 14, 2023
• Study Start: August 21, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)