Actively Recruiting
The Effects of SCFA Supplementation in Subjects Receiving Abdominopelvic RT: A Randomized Controlled Study
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2025-12-10
122
Participants Needed
1
Research Sites
332 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess and compare GI toxicity from RT between subjects who receive therapeutic SCFA and those who receive placebo, in hopes of identifying a safe, low-cost therapeutic to reduce GI toxicity from therapeutic or environmental radiation.
CONDITIONS
Official Title
The Effects of SCFA Supplementation in Subjects Receiving Abdominopelvic RT: A Randomized Controlled Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and HIPAA authorization obtained
- At least 18 years old at consent
- ECOG performance score of 2 or less
- Histological or cytological confirmation of GI, urologic, or gynecologic cancer
- Planned abdominal or pelvic RT with minimum dose of 40Gy using 3D conformal fields or IMRT
- Prior chemotherapy or surgery allowed
- Deemed healthy by physician based on labs and overall health
- Completed prior cancer treatments at least 14 days before enrollment with recovery from acute toxic effects to Grade 1 or baseline (except alopecia)
- Females of childbearing potential must have a negative pregnancy test within 14 days before simulation
- Females of childbearing potential must agree to abstain or use two effective contraception methods from consent until 14-28 days after treatment
- Males with female partners of childbearing potential must have had vasectomy or agree to use double barrier contraception from first dose until 14-28 days after last dose
- Willing and able to comply with study procedures
You will not qualify if you...
- Pregnant or breastfeeding
- Prior abdominopelvic radiation therapy
- History of inflammatory bowel disease or GI motility disorder
- Grade 2 or higher diarrhea at baseline unless caused by prescribed laxatives for partial obstruction
- Concurrent use of histone deacetylase inhibitors (vorinostat)
- Baseline hypernatremia (serum sodium >145 mEg/L)
- Creatinine clearance less than 50 mL/min
- Congestive heart failure
- On medically indicated salt restricted diet
- Severe nut allergy
- Active infection requiring systemic therapy
- Active central nervous system metastases
- Treatment with any investigational drug other than study drugs
- Participation in another clinical trial
- Receiving prohibited medications or treatments that cannot be discontinued or replaced per protocol section 5.6
AI-Screening
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Trial Site Locations
Total: 1 location
1
Flora Danquah
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
F
Flora Danquah
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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