Radiation EsophagitisPhase 2NCT05659576
Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation
A Phase 2 study testing Sucralfate, One consent and Two consent in people with Radiation Esophagitis, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Esophagitis
- What is being tested?
- Sucralfate, One consent and Two consent
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 7 sitesUnited States
- Study dates
- 13 Dec 2022to 26 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Cancer Center Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )
Commack, New York, 11725
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553
About this study
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.
Read the 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).
- Conditions
- Radiation Esophagitis
- Being tested
- Sucralfate, Usual Care, One consent, Two consent
- Keywords
- Gastrointestinal, Sucralfate, Radiation Therapy, Thoracic cancer, 22-307
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucralfateDrug
- 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
- 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".
Usual CareOther
Standard supportive care by using opioids.
One consentOther
Patient will sign one consent form.
Two consentOther
Patient will sign two consent forms.
| Study group | Role | What they receive |
|---|---|---|
| One Stage Consent | Active comparator | Patient will sign one consent form. Receives: Other: One consent |
| Two Stage Consent | Experimental | Patient will sign two consent forms. Receives: Other: Two consent |
| 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. Receives: Drug: Sucralfate |
| Usual Care | Active comparator | Standard supportive care by using opioids. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual rate (Two-stage consent part)
Determine accrual rate of two-stage consent compared to standard onestage consent.
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start13 Dec 2022
- Primary completion26 Aug 2026
- Study completion26 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation EsophagitisStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacob Shin, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659576
- Sponsor's protocol ID
- 22-307
- Status last verified
- Aug 2026
- First submitted
- 13 Dec 2022
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation
- ClinicalTrials.gov ID
- NCT05659576
- Acronym / sponsor ID
- 22-307
- Conditions
- Radiation Esophagitis
- Keywords
- Gastrointestinal, Sucralfate, Radiation Therapy, Thoracic cancer, 22-307
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 26 Aug 2026 (actual)
- Study completion
- 26 Aug 2026 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| One Stage Consent | Active comparator | Other: One consentPatient will sign one consent form. |
| Two Stage Consent | Experimental | Other: Two consentPatient will sign two consent forms. |
| Sucralfate | Experimental | Drug: SucralfateDuring 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 | Other: Usual CareStandard supportive care by using opioids. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients being treated with thoracic irradiation with high-risk esophageal dose as determined below:
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sucralfate1. 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". | Drug | Sucralfate |
| Usual CareStandard supportive care by using opioids. | Other | Usual Care |
| One consentPatient will sign one consent form. | Other | One Stage Consent |
| Two consentPatient will sign two consent forms. | Other | Two Stage Consent |
Primary outcome
Accrual rate (Two-stage consent part)
Time frame: 1 year
Determine accrual rate of two-stage consent compared to standard onestage consent.
Reduce opioid use
Time frame: 2 years
as measured by documented opioid use within the past 24 hours in the EMR at time of final weekly status check
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Radiation Esophagitis
Not yet recruitingPhase 3
Risk-Adapted Segmental Esophagus-Sparing Radiotherapy for Definitive Non-Small Cell Lung Cancer
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RecruitingPhase 2
Esomeprazole and Radiation Induced Esophagitis
Radiation Esophagitis, Locally Advanced Lung Carcinoma
RecruitingPhase 2
PULSO Trial: Pulsed Low-Dose-Rate (PLDR) Radiation Chemoradiation (CRT) vs. Standard CRT for Esophageal Cancer
Esophageal Cancer, Oesophageal Cancer
RecruitingPhase 3
Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer
Non Small Cell Lung Cancer, Small Cell Lung Cancer
Not yet recruiting
Using Red Light Therapy to Ease Skin Side Effects and Mouth Side Effects, in Children and Young People Aged 0 to 16 Years Old, Receiving Radiotherapy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Shin, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sucralfate, One consent and Two consent in people with Radiation Esophagitis, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accrual rate (Two-stage consent part) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.