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Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation
The purpose of the study is to explore options for preventing and reducing symptoms of radiation esophagitis (RE). The researchers will also look what symptoms participants experience, and whether there are differences in weight loss in participants.
Conditions:
🦠 Radiation Esophagitis
🗓️ Study Start (Actual) 13 December 2022
🗓️ Primary Completion (Estimated) December 2025
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 352
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Basking Ridge, New Jersey, United States
📍 Middletown, New Jersey, United States
📍 Montvale, New Jersey, United States
📍 Commack, New York, United States
📍 Harrison, New York, United States
📍 New York, New York, United States
📍 Uniondale, New York, United States
More locations available...

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Patients being treated with thoracic irradiation with high-risk esophageal dose as determined below:
    • Esophageal dose:
    • * V50 ≥ 15% (25-35 once daily fractions) or 40 twice-daily \[BID\] fractions)
    • * V40 ≥ 15% (15-24 once daily fractions or 30 twice-daily \[BID\] fractions)
    • * V30 ≥ 15% (10-14 once daily fractions)
    • * Age 18 years of age or older.

    Exclusion Criteria:

    • * Known inability to take Sucralfate (tablet and/or suspension form), per physician discretion
    • * PEG tube
    • * Actively taking any opioid pain medications prior to radiation therapy
    • * History of an opioid use disorder
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 13 December 2022
  • First Submitted that Met QC Criteria 13 December 2022
  • First Posted 21 December 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 December 2023
  • Last Update Posted 13 December 2023
  • Last Verified December 2023
I'm interested ...!!