The Effects of SCFA Supplementation in Subjects Receiving Abdominopelvic RT: A Randomized Controlled Study

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNC Lineberger Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Short Chain Fatty Acid
  • Tapioca Flour

Treatment groups

122 Participants
are divided into 2 treatment groups