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SCFA Supplementation for Radiation Poisoning
Phase 1 & 2
Recruiting
Led By Andrew Wang, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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).
≥ 18 years of age on day of signing informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline- up to 5 years post rt
Awards & highlights
Study Summary
This trial is testing whether a common, safe, and low-cost therapy can help reduce gastrointestinal toxicity from radiation therapy.
Who is the study for?
Adults over 18 with GI, urologic or gynecologic cancers needing abdominopelvic radiation can join. They should be fairly healthy, have an ECOG score ≤2, and could've had prior chemo or surgery. Women must use contraception; men with partners of childbearing potential must do the same or be vasectomized.Check my eligibility
What is being tested?
This study tests if SCFA supplementation reduces gastrointestinal toxicity from radiation therapy compared to a placebo (tapioca flour). Participants are randomly assigned to either the SCFA group or the placebo group to see which is more effective.See study design
What are the potential side effects?
Potential side effects may include digestive issues due to SCFA or tapioca flour intake. However, since these are generally considered safe substances, severe side effects are not commonly expected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a confirmed GI, urologic, or gynecologic cancer and will receive radiation of at least 40Gy to my abdomen or pelvis.
Select...
I am 18 years old or older.
Select...
I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline- up to 5 years post rt
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline- up to 5 years post rt
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The rate and severity of patient reported and physician determined toxicities between subjects who receive therapeutic SCFA and those who receive placebo.
Secondary outcome measures
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.
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.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Short Chain Fatty Acid (SCFA)Active Control1 Intervention
4-6 grams of powder mixed with food and taken everyday starting 1 week prior-1 week post Radiation Therapy.
Group II: Placebo (Tapioca)Placebo Group1 Intervention
5 grams taken everyday starting 1 week prior-1 week post Radiation Therapy.
Find a Location
Who is running the clinical trial?
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
351 Previous Clinical Trials
88,211 Total Patients Enrolled
Andrew Wang, MDPrincipal InvestigatorUNC
3 Previous Clinical Trials
289 Total Patients Enrolled
Shivani Sud, MDPrincipal InvestigatorUNC
3 Previous Clinical Trials
2,115 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a confirmed GI, urologic, or gynecologic cancer and will receive radiation of at least 40Gy to my abdomen or pelvis.I am not taking any medications or treatments that are not allowed in this study.I am currently taking vorinostat.I have had radiation therapy to my abdomen or pelvis.I finished my last cancer treatment 14 days ago and have recovered from its side effects.My kidney function is reduced with a creatinine clearance below 50 mL/min.I am a man who will use birth control during and after the study if my partner can have children.I am a woman who can have children and have a recent negative pregnancy test.I have moderate to severe diarrhea not caused by laxatives.I have active cancer spread to my brain or spinal cord.I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.I have had chemotherapy or surgery before.I am currently on medication for an infection.You have a severe allergy to nuts.I have a history of inflammatory bowel disease or problems with my digestive system's movement.I have been diagnosed with congestive heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo (Tapioca)
- Group 2: Short Chain Fatty Acid (SCFA)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there other ongoing investigations related to Short Chain Fatty Acid (SCFA)?
"There are currently 6 ongoing trials studying the efficacy of Short Chain Fatty Acid (SCFA). 2 of these trials have progressed to Phase 3. The majority of research locations for SCFA are in Chapel Hill, North carolina; although, there are a total 12 sites running clinical trials for this medication."
Answered by AI
Are new patients being enrolled in this research project at this time?
"No, this particular clinical trial is not currently looking for new participants. This is based on the information available on clinicaltrials.gov which shows that the last update to this study was made on 11/11/2022. That said, there are 50 other trials happening right now that are accepting patients."
Answered by AI
To date, how many people have signed up for this clinical research?
"Unfortunately, this particular study is no longer recruiting volunteers. The trial was originally posted on 1/1/2023 but the most recent update was 11/11/2022. There are currently 44 other studies that deal with radiation toxicity and 6 for Short Chain Fatty Acid (SCFA) actively looking for patients if you are interested in participating in a clinical trial."
Answered by AI
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