UNC Lineberger Comprehensive Cancer Center
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.
Radiation therapy is a critical modality for treatment of urologic, gynecologic and gastrointestinal malignancies among others. Though advances in treatment techniques have reduced treatment-associated morbidity and mortality, normal tissue toxicity still limits dose escalation and treatment tolerance. Over 50% of patients receiving abdominal or pelvic radiation therapy (RT) develop clinically meaningful toxicity. Pharmacologic strategies to reduce normal tissue damage represent a tremendous unmet need in RT. Investigators propose a novel application of short chain fatty acids (SCFA) as a ther…
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 fr…
Participants will take the supplement as prescribed to determine if it can help with GI toxicity
Participants taking this will be used as a control group compared to those receiving the SCFA supplement
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