ACTIVE_NOT_RECRUITING

Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation

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Conditions

Radiation EsophagitisGastrointestinalSucralfateRadiation TherapyThoracic cancer22-307

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation

Quick Facts

Study Start:2022-12-13
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05659576

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients being treated with thoracic irradiation with high-risk esophageal dose as determined below:
  2. * V50 ≥ 15% (25-35 once daily fractions) or 40 twice-daily \[BID\] fractions)
  3. * V40 ≥ 15% (15-24 once daily fractions or 30 twice-daily \[BID\] fractions)
  4. * V30 ≥ 15% (10-14 once daily fractions)
  5. * Age 18 years of age or older.
  1. * Known inability to take Sucralfate (tablet and/or suspension form), per physician discretion
  2. * PEG tube
  3. * Actively taking any opioid pain medications prior to radiation therapy
  4. * History of an opioid use disorder

Contacts and Locations

Principal Investigator

Jacob Shin, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Jacob Shin, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

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

Study Start Date2022-12-13
Study Completion Date2026-12

Study Record Updates

Study Start Date2022-12-13
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Gastrointestinal
  • Sucralfate
  • Radiation Therapy
  • Thoracic cancer
  • 22-307

Additional Relevant MeSH Terms

  • Radiation Esophagitis