Reducing side effects of radiation therapy for thoracic cancer
Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation
This study is testing if a medication can help reduce the painful side effects of radiation therapy in people with thoracic cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 352 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT05659576 on ClinicalTrials.gov |
What this trial studies
This study aims to prevent and alleviate symptoms of radiation esophagitis in patients undergoing thoracic irradiation. It employs a two-stage consent design to compare different methods of informing patients about the trial, alongside a randomized comparison of sucralfate versus a control treatment. Participants will be monitored for symptom experiences and weight loss during the treatment period. The study seeks to improve patient outcomes by addressing the gastrointestinal side effects associated with radiation therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing thoracic irradiation with a high risk of esophageal dose.
Not a fit: Patients who cannot take sucralfate or have a history of opioid use disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the discomfort and complications associated with radiation esophagitis in patients receiving thoracic radiation.
How similar studies have performed: Other studies have shown promise in reducing radiation-induced side effects, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Cancer Center Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities ) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jacob Shin, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Jacob Shin, MD
- Email: shinj2@mskcc.org
- Phone: 848-225-6436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.