TROS-7: CPAP for Esophageal Cancer With Radiotherapy

• Sponsor: Sheba Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06037902
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 49.3
• Patients Per Site Per Month: 0.9

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Device: CPAP	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 44 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: all patients undergo two simulations.all patients undergo two simulations.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Use of CPAP (Continuous Positive Airway Pressure) for Simulating Esophageal Cancer Patients Prior to Radiotherapy
• Actual Study Start Date: Aug 21, 2023
• Anticipated Primary Completion Date: Sep 30, 2027
• Anticipated Study Completion Date: Sep 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CPAP patients will undergo simulation twice, with and without CPAP	Device: CPAP; patients undergo simulation twice, with and without CPAP

Outcome Measures

Primary Outcome Measures

1. absolute mean heart radiation dose [on day of simulation (day 1)]

   measured in Gy

Secondary Outcome Measures

1. lung dose in Gy [on day of simulation (day 1)]

   mean lung dose, V5 and V20

2. heart dose in Gy [on day of simulation (day 1)]

   mean heart dose, V30

3. movement of tumor in cm [on day of simulation (day 1)]

   how much tumor moves with breathing

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Diagnosis of cancer, with a tumor (primary or secondary) in the esophagus including tumors in the esophagus-stomach junction.

2. Age ≥ 18

3. Planned RT treatment

4. The level of functioning ≥ 60 on the Karnofsky scale

5. Life expectancy ≥ two months

6. 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.

7. Able to undergo simulation and radiation with CPAP

8. 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:

1. Pregnancy or breastfeeding

2. Significant comorbidity at the starting point that would prevent the use of CPAP

3. Hospitalized in an institution by virtue of an administrative order or a court order.

4. Special population

5. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sheba Medical Center	Ramat Gan		Israel	52621

Sponsors and Collaborators

• Sheba Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Yaacov Lawrence, Chair of Department of Radiation Oncology, principal investigator, Sheba Medical Center
• ClinicalTrials.gov Identifier: NCT06037902
• Other Study ID Numbers: SHEBA-22-0032-YL-CTIL
• First Posted: Sep 14, 2023
• Last Update Posted: Sep 14, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Dr. Yaacov Lawrence, Chair of Department of Radiation Oncology, principal investigator, Sheba Medical Center: radiation
• Additional relevant MeSH terms: Esophageal Neoplasms

Study Results

No Results Posted as of Sep 14, 2023