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NCT05659576 | RECRUITING | Radiation Esophagitis

Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation
Sponsor:

Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease

Radiation Esophagitis

Intervention/treatment

Sucralfate

Usual Care

One consent

Two consent

Phase

PHASE2

Detailed 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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 352 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation
Actual Study Start Date : 2022-12-13
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation

Location Details

NCT05659576

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New Jersey

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

Basking Ridge, New Jersey, United States, 07920

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States, 07748

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States, 07645

RECRUITING

United States, New York

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )

Commack, New York, United States, 11725

RECRUITING

United States, New York

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States, 10604

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

RECRUITING

United States, New York

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, United States, 11553