What side effects are associated with this type of intervention?

Common treatments for colorectal cancer that impact metabolic processes and inflammation, such as dietary interventions and SCFA supplementation, can have various side effects. For instance, butyrate enemas, while generally safe, have shown limited efficacy and no significant toxicity. Chemotherapy, a standard treatment, often causes side effects like nausea, fatigue, and increased risk of infection. NSAIDs like aspirin, used for their anti-inflammatory properties, can reduce the risk of adenomas but may cause gastrointestinal issues and bleeding. Overall, while metabolic modulators like BHB are being explored, their side effect profiles are still under investigation.

What prior FDA approvals exist?

The FDA has approved several treatments for colorectal cancer that target metabolic processes and inflammation. Notably, drugs like cetuximab and panitumumab target the epidermal growth factor receptor (EGFR), impacting cell proliferation and survival. Additionally, anti-inflammatory agents like aspirin have shown promise in reducing colorectal cancer risk by inhibiting cyclooxygenase enzymes. While BHB supplementation specifically as an alternative energy source is still under investigation, these approved treatments share the common goal of modulating key metabolic and inflammatory pathways in colorectal cancer.

What other types of research exist?

Promising alternatives to Beta-hydroxybutyrate (BHB) supplementation for colorectal cancer patients include: 1) Dietary fibers that increase butyrate production, such as wheat bran, which has been shown to reduce tumor mass and incidence. 2) Eicosapentaenoic acid (EPA), which has anti-inflammatory properties and can help manage cancer cachexia. 3) Probiotics and berberine, which modulate gut microbiota and increase butyrate production, potentially reducing tumor growth.

← Back to Search

Ketone Body Supplement

Ketone Supplement for Colorectal Cancer Prevention (BHB-CRC Trial)

N/A

Waitlist Available

Led By Bryson W Katona, MD, PhD

Research Sponsored by Abramson Cancer Center of the University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age of 18 years or older

Be older than 18 years old

Must not have

History of inflammatory bowel disease

History of diabetes mellitus and currently on medical diabetes therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, which will be approximately 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a BHB supplement, which is a type of ketone used for energy, in patients having a colonoscopy or flexible sigmoidoscopy. The goal is to see if the supplement is safe and if it changes the cells in the colon.

Who is the study for?

This trial is for adults over 18 who can consent and are scheduled for a standard colonoscopy or flexible sigmoidoscopy. It's not suitable for those with diabetes on medication, severe kidney disease, active cancer treatment, pregnancy, incarceration, under 18s, history of bowel diseases or recent fasting diets.

What is being tested?

The study tests if taking β-hydroxybutyrate (BHB) supplement is feasible for people getting routine colon checks. BHB is thought to help in preventing colorectal cancer.

What are the potential side effects?

Potential side effects of BHB supplementation may include gastrointestinal discomfort such as nausea or stomach pain. Since this is an initial investigation, other unexpected side effects might be observed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of inflammatory bowel disease.

Select...

I have diabetes and am currently receiving treatment for it.

Select...

I am currently undergoing treatment for my cancer.

Select...

I cannot have a colonoscopy or flexible sigmoidoscopy.

Select...

I have had surgery to remove my colon and rectum.

Select...

I am not pregnant, imprisoned, or under 18.

Select...

My kidney function is reduced with an eGFR below 60.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, which will be approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, which will be approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, which will be approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine whether oral BHB supplementation is safe and tolerable

Secondary study objectives

Determine whether oral BHB supplementations increases serum BHB levels

Investigate whether oral BHB supplementation leads to transcription and protein expression changes in the colonic mucosa

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: BHB supplementationExperimental Treatment1 Intervention

Study participants will be taking 35mL of HVMN Ketone-IQ by mouth three times daily, with each dose containing 10 grams of R-1,3-Butanediol, for a total of 4 weeks.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for colorectal cancer include chemotherapy, targeted therapy, immunotherapy, and emerging treatments like Beta-hydroxybutyrate (BHB) supplementation. Chemotherapy works by killing rapidly dividing cancer cells, while targeted therapy focuses on specific molecular targets involved in cancer growth and progression. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. BHB supplementation, an alternative energy source, impacts metabolic processes and inflammation, potentially inhibiting cancer cell growth and improving patient outcomes. Understanding these mechanisms helps tailor treatments to individual patient needs, improving efficacy and reducing side effects.

Effects of Intestinal Microbial⁻Elaborated Butyrate on Oncogenic Signaling Pathways.The enhancement of phase 2 enzyme activities by sodium butyrate in normal intestinal epithelial cells is associated with Nrf2 and p53.