Recruiting
Phase 1
Phase 2

SCFA Supplementation

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT04700527

Conditions

Toxicity

Radiation Toxicity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Short Chain Fatty Acid

Tapioca Flour

Study Details

Brief summary:

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

Toxicity

Radiation Toxicity

Study ID

NCT04700527

Start date

Dec 15, 2023

Status verified date

Jun, 2026

Completion date

May, 2031

Anticipated

Primary completion date

Apr 21, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

122 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Short Chain Fatty Acid (SCFA)

4-6 grams of powder mixed with food and taken everyday starting 1 week prior-1 week post Radiation Therapy.

placebo comparator: Placebo (Tapioca)

5 grams taken everyday starting 1 week prior-1 week post Radiation Therapy.

Interventions

Short Chain Fatty Acid

Participants will take the supplement as prescribed to determine if it can help with GI toxicity

Tapioca Flour

Participants taking this will be used as a control group compared to those receiving the SCFA supplement

Primary outcome measure

  • The rate and severity of patient reported and physician determined toxicities between subjects who receive therapeutic SCFA and those who receive placebo. [ Time Frame: baseline-3 months ]

Central Contacts and Locations

Central contacts

Flora Danquah

9849748441flora_danquah@med.unc.edu

Locations

Flora Danquah

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Flora Danquah

984-974-8441flora_danquah@med.unc.edu

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Sep 3, 2026

Last verified

Jun, 2026

Keywords

  • GI cancer
  • Urinary cancer
  • Gynecological Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-09-03.