Clinical trial · Interventional
Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation
NCT05659576CI-TRIAL-00124209completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation Esophagitis | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| One consent | Other | — | UNRESOLVED |
| Sucralfate | Drug | — | UNRESOLVED |
| Two consent | Other | — | UNRESOLVED |
| Usual Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- One Stage Consent
- description
- Patient will sign one consent form.
- interventionNames
- Other: One consent
- type
- EXPERIMENTAL
- label
- Two Stage Consent
- description
- Patient will sign two consent forms.
- interventionNames
- Other: Two consent
- type
- EXPERIMENTAL
- label
- Sucralfate
- description
- During 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.