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New treatment option for Toxicity
Official title The Effects of SCFA Supplementation in Subjects Receiving Abdominopelvic RT: A Randomized Controlled Study
ClinicalTrials.gov ID: NCT04700527
What this study is testing
What is Short Chain Fatty Acid?
Short Chain Fatty Acid is an investigational medicine, given as an once-daily, being studied as a potential treatment for toxicity.
Also referred to as Sodium butyrate and sodium propionate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Consent for the use...
- ≥ 18 years of age on day of signing informed consent.
- ECOG performance score ≤ 2
- people with histological or cytological evidence/confirmation of GI, urologic or gynecologic malignancy that will be treated with minimum dose of...
- people may have had prior chemotherapy or surgery.
You likely can't join 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
See the full eligibility 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...
- ≥ 18 years of age on day of signing informed consent.
- ECOG performance score ≤ 2
- people 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...
- people may have had prior chemotherapy or surgery.
- people deemed healthy for study inclusion by the treating physician based on the laboratory values at screening and general health status.
- 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...
- 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...
- Male people 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...
- people is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
- 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 people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.