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

NCT04700527 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: LCCC2032
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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

Keywords

GI cancer; Urinary cancer; Gynecological Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline-3 months

Secondary Outcomes (2)

• 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.

  baseline- up to 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.

  baseline- 3 months

Study Arms (2)

Short Chain Fatty Acid (SCFA)

ACTIVE COMPARATOR

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

Drug: Short Chain Fatty Acid

Placebo (Tapioca)

PLACEBO COMPARATOR

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

Drug: Tapioca Flour

Interventions

Tapioca Flour DRUG

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

Placebo (Tapioca)

Short Chain Fatty Acid DRUG

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

Also known as: Sodium butyrate and sodium propionate

Short Chain Fatty Acid (SCFA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Subjects may have had prior chemotherapy or surgery.
• 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.

You may not qualify if:

• 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
• 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 infection requiring systemic therapy.
• Active central nervous system (CNS) metastases
• Treatment with any investigational drug other than the drugs in this study and subjects may not be on another clinical trial.
• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

Flora Danquah

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Radiation Injuries; Gastrointestinal Neoplasms

Interventions

Fatty Acids, Volatile; Butyric Acid; sodium propionate

Condition Hierarchy (Ancestors)

Wounds and Injuries; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids; Lipids; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Shivani Sud, MD

  UNC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Flora Danquah

CONTACT

9849748441; flora_danquah@med.unc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: January 8, 2021
• Study Start: December 15, 2023
• Primary Completion: April 21, 2026
• Study Completion (Estimated): May 1, 2030
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

US (1)