SCFA Supplementation for Radiation Toxicity
This study is looking at whether a supplement called Short Chain Fatty Acid (SCFA) can help reduce stomach and bowel problems (gastrointestinal or GI toxicity) caused by radiation therapy (RT) for cancers in the abdomen or pelvis. You would be randomly assigned to receive either the SCFA supplement or Tapioca Flour (a placebo, or inactive substance). Researchers want to see if SCFA can lower the number and seriousness of these side effects, as reported by you and your doctor, over three months. To join, you need to be at least 18 years old and provide written consent. The study aims to find a safe, affordable way to lessen GI toxicity from radiation.
- Study design
- This is a randomized controlled study, meaning participants are randomly assigned to one of two groups. It plans to enroll 122 participants.
- What's involved
- You would take the assigned supplement daily starting one week before radiation therapy and continuing for one week after it ends. You will also keep a daily log and complete surveys about side effects from baseline through 3 months after radiation therapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for three months after completing radiation therapy to assess side effects.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04700527
The Effects of SCFA Supplementation in Subjects Receiving Abdominopelvic RT: A Randomized Controlled Study
Recruiting
PHASE1Ages 18+InterventionalTreatmentUNC Lineberger Comprehensive Cancer CenterInvestigator-initiated
~122 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:Short Chain Fatty AcidTapioca Flour
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The rate and severity of patient reported and physician determined toxicities between subjects who receive therapeutic SCFA and those who receive placebo.
Measured over baseline-3 months
Conditions
Where it's being run
1 sites across 1 statesNorth Carolina1
Study leadership
- Shivani Sud, MD · PRINCIPAL_INVESTIGATOR · UNC
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Consent for the use of any residual material from biopsy and/or surgical resection (archival tissue) and serial blood draws will be required for enrollment.
≥ 18 years of age on day of signing informed consent.
ECOG performance score ≤ 2
Subjects with histological or cytological evidence/confirmation of GI, urologic or gynecologic malignancy that will be treated with minimum dose of 40Gy (equivalent dose in 2Gy per fraction or EQD2) via 3D conformal fields or IMRT to abdomen or pelvis (multimodality treatment with surgery, chemotherapy is permissible)
Subjects may have had prior chemotherapy or surgery.
Subjects deemed healthy for study inclusion by the treating physician based on the laboratory values at screening and general health status.
Prior cancer treatment must be completed at least 14 days prior to registration and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤ Grade 1 or baseline.
Females of childbearing potential must have a negative urine pregnancy test within 14 days prior to simulation. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. Documentation of postmenopausal status must be provided.
Females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 14 or 28 days after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets \< 1% failure rate for protection from pregnancy in the product label.
Male subjects with female partners of childbearing potential must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 14-28 days after the last dose of study therapy.
Subjects is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
Exclusion
Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
Prior abdominopelvic RT
History of inflammatory bowel disease or GI motility disorder
Grade 2 or higher diarrhea at baseline unless deemed by the investigator to be caused by laxatives prescribed for symptomatic partial obstruction
Concurrent use of histone deacetylase inhibitors (vorinostat)
Baseline hypernatremia defined as serum sodium concentration \>145 mEg/L
Creatinine clearance \< 50 mL/min
Congestive heart failure
On a salt restricted diet for medical indications
Severe nut allergy
Active infection requiring systemic therapy.
Active central nervous system (CNS) metastases
Treatment with any investigational drug other than the drugs in this study and subjects may not be on another clinical trial.
Subject is receiving prohibited medications or treatments as listed in section 5.6 of the protocol that cannot be discontinued/replaced by an alternative therapy.
What this trial measures
- The rate and severity of patient reported and physician determined toxicities between subjects who receive therapeutic SCFA and those who receive placebo.baseline-3 months
GI toxicities (PRO-CTCAE v5 for patients and CTCAE v5 for physicians) will be recorded and compared between the 2 groups to identify any differences.