Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 2

Conditions: Radiation Esophagitis

Treatments: Drug: Sucralfate; Other: Two consent; Other: Usual Care; Other: One consent

Study type: Interventional

Funder types: Other

Identifiers

NCT05659576

22-307

Details and patient eligibility

About

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.

Full 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).

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 4 patient groups

One Stage Consent

Active Comparator group

Description:

Patient will sign one consent form.

Treatment:

Other: One consent

Two Stage Consent

Experimental group

Description:

Patient will sign two consent forms.

Treatment:

Other: Two consent

Sucralfate

Experimental group

Description:

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.

Treatment:

Drug: Sucralfate

Usual Care

Active Comparator group

Description:

Standard supportive care by using opioids.

Treatment:

Other: Usual Care