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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT04700527
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Radiation Toxicity
  • Toxicity

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 15, 2023
Status verified
Jun 2026
Primary completion
Apr 21, 2027
Completion
May 31, 2031

Study Design

Enrollment
122 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Short Chain Fatty Acid (SCFA)
    4-6 grams of powder mixed with food and taken everyday starting 1 week prior-1 week post Radiation Therapy.
  • Placebo Comparator: Placebo (Tapioca)
    5 grams taken everyday starting 1 week prior-1 week post Radiation Therapy.

Primary Outcome Measure

The rate and severity of patient reported and physician determined toxicities between subjects who receive therapeutic SCFA and those who receive placebo. [ Time Frame: baseline-3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Flora DanquahChapel HillNorth Carolina27599
Flora Danquah
[email protected]
984-974-8441

Find similar trials in Chapel Hill, NC

By research site
Flora Danquah· Chapel Hill, NC

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