Status:
RECRUITING
Investigation of β-hydroxybutyrate Supplementation as Chemoprevention in Familial Adenomatous Polyposis
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Collaborating Sponsors:
The V Foundation for Cancer Research
Conditions:
FAP
Familial Adenomatous Polyposis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to evaluate the potential of BHB supplementation as a novel strategy to impede the development and progression of intestinal adenomas in individuals with FAP, thus potentially...
Detailed Description
We plan to undertake both an initial absorption study (Part A) in up to 9 individuals with FAP followed by a longitudinal open-label study (Part B) in up to 20 individuals with FAP, who will receive R...
Eligibility Criteria
Inclusion
- Part A
- Have a diagnosis of FAP with genetic testing demonstrating a pathogenic or likely pathogenic germline variant in APC, must have a clinical FAP phenotype with at least one member of the family who has a pathogenic or likely pathogenic germline variant in APC, or must have a clinical diagnosis of FAP as agreed by two gastrointestinal cancer genetics experts
- Must have an extensive colonic resection with either a subtotal colectomy with ileorectal anastomosis (STC-IRA) or total proctocolectomy with ileal pouch anal anastomosis (TPC-IPAA)
- Can provide informed consent
Exclusion
- Subject is pregnant, a prisoner, or is under 18 years of age
- Prior total proctocolectomy with end ileostomy
- History of inflammatory bowel disease
- History of diabetes mellitus and are currently on medical diabetes therapy
- History of chronic kidney disease with an eGFR \< 60 mL/min/1.73m2
- Cancer diagnosis where the subject is receiving active therapy
- Use of either a ketogenic diet or intermittent fasting (defined as a fasting period of 16 hours or more per day that is not associated with a medical procedure) during the 4 weeks prior to enrollment
- Part B
- Inclusion Criteria:
- Have a diagnosis of FAP with genetic testing demonstrating a pathogenic or likely pathogenic germline variant in APC, must have a clinical FAP phenotype with at least one member of the family who has a pathogenic or likely pathogenic germline variant in APC, or must have a clinical diagnosis of FAP as agreed by two gastrointestinal cancer genetics experts.
- Willing to undergo a colonoscopy or sigmoidoscopy, which may be part of the patient's routine standard care.
- Able to have a concurrent upper endoscopy performed with the colonoscopy/sigmoidoscopy. This upper endoscopy may be part of the patient's routine standard care.
- Have at least two colorectal polyps at enrollment (which can be present anywhere in the colon including the rectal cuff, or in the J-pouch \[if applicable\]).
- Can provide informed consent.
Key Trial Info
Start Date :
September 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06578637
Start Date
September 20 2024
End Date
October 1 2027
Last Update
September 4 2025
Active Locations (1)
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1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104