Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation
1 other identifier
interventional
142
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2022
Typical duration for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2022
CompletedStudy Start
First participant enrolled
December 13, 2022
CompletedFirst Posted
Study publicly available on registry
December 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 27, 2026
January 1, 2026
4 years
December 13, 2022
January 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Accrual rate (Two-stage consent part)
Determine accrual rate of two-stage consent compared to standard onestage consent.
1 year
Reduce opioid use
as measured by documented opioid use within the past 24 hours in the EMR at time of final weekly status check
2 years
Study Arms (4)
One Stage Consent
ACTIVE COMPARATORPatient will sign one consent form.
Two Stage Consent
EXPERIMENTALPatient will sign two consent forms.
Sucralfate
EXPERIMENTALDuring their RT course, patients randomized to the PS arm will receive a prescription for either: 1) sucralfate, 1 gram/10 mL oral suspension or 2) sucralfate 1 gram tablets.
Usual Care
ACTIVE COMPARATORStandard supportive care by using opioids.
Interventions
1. Sucralfate, 1 gram/10 mL oral suspension "By mouth, take 10 mL twice a day until RT completion, with one dose 30-60 minutes prior to their midday meal and the second dose prior to bedtime".May increase frequency up to 4 times per day, per physician discretion". Or 2. Sucralfate 1 gram tablets By mouth, take one (1) tablet mixed in 15-30 mL warm water twice a day until RT completion, with one dose 30-60 minutes prior to their midday meal and the second dose prior to bedtime". The frequency of sucralfate can be adjusted at anytime at the treating physician's discretion after the patient has started it at twice a day, and the patient may discontinue sucralfate at anytime after RT completion, per physician discretion. May increase frequency up to 4 times per day, per physician discretion".
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
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
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacob Shin, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2022
First Posted
December 21, 2022
Study Start
December 13, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 27, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.