Clinical trial NCT05659576: Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation
Official title: Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Radiation Esophagitis
Keywords: Gastrointestinal
Sucralfate
Radiation Therapy
Thoracic cancer
22-307
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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 traditional onestage 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).

Eligibility criteria: 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

Primary outcomes:
measure: Accrual rate (Two-stage consent part)
timeFrame: 1 year
measure: Reduce opioid use
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center Basking Ridge (All Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jacob Shin, MD
role: PRINCIPAL_INVESTIGATOR
References: