Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 and up

Effects of SCFA supplements on GI toxicity in cancer patients receiving radiation therapy

Official title: LCCC2032: The Effects of Short Chain Fatty Acid Supplementation on the Quality of Life and Treatment-related Toxicities in Subjects Receiving Abdominopelvic Radiotherapy: A Randomized Controlled Study

Run by UNC Lineberger Comprehensive Cancer Center · NCT04700527 · Data updated 2026-11-12

This study is testing if taking short chain fatty acid supplements can help reduce stomach and gut problems in cancer patients getting radiation therapy.

More Radiation Toxicity trials

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment122 (estimated)
SponsorUNC Lineberger Comprehensive Cancer Center
Academic / other
Drugs / interventionschemotherapy, radiation
Locations1 site (Chapel Hill, North Carolina)
StatusRecruiting
StartedDecember 15, 2023
Main results expectedApril 21, 2027
Study endsMay 2031
Registry record updatedOctober 5, 2026
Trial IDNCT04700527 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older with confirmed GI, urologic, or gynecologic malignancies scheduled for radiation therapy.

Probably not a fit

Patients who are not undergoing radiation therapy or have a performance score greater than 2 may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the impact of short chain fatty acid (SCFA) supplementation on gastrointestinal (GI) toxicity in patients undergoing radiation therapy for urologic, gynecologic, or gastrointestinal cancers. Participants will be randomly assigned to receive either SCFA supplements or a placebo, starting one week before radiation treatment and continuing for one week after. The study will track patient-reported outcomes and physician assessments of toxicity over a period of up to five years. The goal is to identify a safe and cost-effective method to mitigate radiation-induced GI toxicity.

Why it matters

Potential benefit: If successful, this study could provide a novel therapeutic option to reduce GI toxicity in patients undergoing radiation therapy.

How similar studies have gone: While the use of SCFA in this context is novel, other studies have explored similar approaches to mitigate radiation toxicity with varying degrees of success.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 (including sarcoma) 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, systemic anti cancer therapy 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 Criteria:

* Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
* Prior abdominopelvic RT to a region with anticipated direct overlap with the present planned course of 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 central nervous system (CNS) metastases
* Subject must have completed treatment with any investigational drug other than the drugs in this study and subjects may not be on another clinical trial by no less than 14 days prior to registration. Subjects participating in interventional trials that does not include an investigational agent or any other drug are allowed at the discretion of the principal investigator.
* 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.

Where it's running

  • Flora Danquah
    Chapel Hill, North Carolina, United States
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.