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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One Stage Consent | Active Comparator | Patient will sign one consent form. |
|
| Two Stage Consent | Experimental | Patient will sign two consent forms. |
|
| Sucralfate | Experimental | 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. |
|
| Usual Care | Active Comparator | Standard supportive care by using opioids. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sucralfate | Drug |
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". |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Shin, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center Basking Ridge (All Protocol Activities) | Basking Ridge | New Jersey | 07920 | United States | ||
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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.
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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.
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| Usual Care | Other | Standard supportive care by using opioids. |
|
| One consent | Other | Patient will sign one consent form. |
|
| Two consent | Other | Patient will sign two consent forms. |
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| 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 |
| ID | Term |
|---|---|
| D013392 | Sucralfate |
| ID | Term |
|---|---|
| D013865 | Thioglycosides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013395 | Sucrose |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
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