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Active, Not Recruiting

NCT Number: NCT05659576

Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Radiation Esophagitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Cancer Center Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sucralfate

Drug
  • 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 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.

Primary outcomes

  1. Accrual rate (Two-stage consent part)

    Time frame: 1 year

    Determine accrual rate of two-stage consent compared to standard onestage consent.

  2. 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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 21, 2022
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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