NCT04700527

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 therapeutic to reduce incidence and severity of gastrointestinal (GI) toxicity from RT. Short chain fatty acids (SCFA) are fatty acids with fewer than six carbon atoms ingested or formed during bacterial fermentation of partially- and non-digestible polysaccharides carbohydrates. Patients who are enrolled will be randomized to receive SCFA supplements or a placebo, and will start taking it everyday one week prior to starting RT through 1 week after completing RT. Patients will keep a log of daily administration during the entire time while taking the study drug, and will complete patient reported outcomes (PROs) involving toxicities starting at baseline through 3 months post RT. The patient's treating physician will also complete an assessment of the patients toxicities starting at the baseline through follow up visits up to 5 years post RT, which will be used to compare to the PROs.

Conditions

• Toxicity
• Radiation Toxicity

Interventions

Type	Name	Description
DRUG	Short Chain Fatty Acid	Participants will take the supplement as prescribed to determine if it can help with GI toxicity
DRUG	Tapioca Flour	Participants taking this will be used as a control group compared to those receiving the SCFA supplement

Timeline

• Start date: 2023-12-15
• Primary completion: 2026-04-21
• Completion: 2030-05-01
• First posted: 2021-01-08
• Last updated: 2025-12-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study