Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation

Last updated: October 1, 2024
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

2

Condition

Heartburn

Esophageal Disorders

Heartburn (Pediatric)

Treatment

Usual Care

Sucralfate

Two consent

Clinical Study ID

NCT05659576
22-307
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients being treated with thoracic irradiation with high-risk esophageal dose asdetermined 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

Exclusion Criteria:

  • Known inability to take Sucralfate (tablet and/or suspension form), per physiciandiscretion

  • PEG tube

  • Actively taking any opioid pain medications prior to radiation therapy

  • History of an opioid use disorder

Study Design

Total Participants: 352
Treatment Group(s): 4
Primary Treatment: Usual Care
Phase: 2
Study Start date:
December 13, 2022
Estimated Completion Date:
December 31, 2025

Study Description

Embedded Randomized Study to Assess Two-Stage Consent Design:

There will be two separate randomizations in this study, one vs. two-stage consent and sucralfate vs. control. The will first approach patients and explain that we are comparing different methods of informing patients about trials. If the patients do not wish to participate in the consent trial, participants will be approached for consent onto the therapeutic trial using the traditional onestage research consent.

Patients who decline or who are not approached to take part in the randomized compression of consent methods based on physician discretion, may still take part in the randomized comparison of sucralfate vs. control (therapeutic trial).

Connect with a study center

  • Memorial Sloan Kettering Cancer Center Basking Ridge (All Protocol Activities)

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    Montvale, New Jersey 07645
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )

    Commack, New York 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Nassau (All Protocol Activities)

    Uniondale, New York 11553
    United States

    Active - Recruiting

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