Radiation Esophagitis
Conditions
Keywords
Gastrointestinal, Sucralfate, Radiation Therapy, Thoracic cancer, 22-307
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.
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 twostage 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).
Interventions
DRUGSucralfate
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".
OTHERUsual Care
Standard supportive care by using opioids.
OTHEROne consent
Patient will sign one consent form.
OTHERTwo consent
Patient will sign two consent forms.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a two-arm randomized study. There will be two separate randomizations in this study, one vs. two-stage consent and sucralfate vs. control.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accrual rate (Two-stage consent part) | 1 year | Determine accrual rate of two-stage consent compared to standard onestage consent. |
| Reduce opioid use | 2 years | as measured by documented opioid use within the past 24 hours in the EMR at time of final weekly status check |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJacob Shin, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed