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.
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)
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
Parallel
Short Chain Fatty Acid
DrugParticipants will take the supplement as prescribed to determine if it can help with GI toxicity
Tapioca Flour
DrugParticipants taking this will be used as a control group compared to those receiving the SCFA supplement
The rate and severity of patient reported and physician determined toxicities between subjects who receive therapeutic SCFA and those who receive placebo.
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.
Physician determined acute toxicity profile using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) for both subjects who receive therapeutic SCFA versus those who receive placebo.
Physicians will complete toxicity assessments using the CTCAE v5 at each visit with the patient up until 5 years post RT
Subject reported acute toxicity profile as ascertained by patient-reported outcomes version of the CTCAE (PRO-CTCAE) for both subjects who receive therapeutic SCFA versus those who receive placebo.
Patients will complete PRO-CTCAE at each visit starting at baseline through 3 months after completing the study drug.
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