What side effects are associated with this type of intervention?

Common treatments for colorectal cancer include dietary modifications, chemotherapy, radiation therapy, and surgery. Dietary modifications, such as increasing fiber intake through foods like beans, generally have minimal side effects but may cause gastrointestinal discomfort, such as bloating or gas, in some individuals. Chemotherapy can lead to side effects like nausea, vomiting, fatigue, hair loss, and increased risk of infections. Radiation therapy may cause skin irritation, fatigue, and gastrointestinal symptoms like diarrhea. Surgery carries risks of infection, bleeding, and complications related to anesthesia. Each treatment's side effects vary based on individual patient factors and specific treatment protocols.

What prior FDA approvals exist?

FDA approvals for colorectal cancer treatments have primarily focused on pharmaceuticals, including chemotherapy agents like 5-fluorouracil, targeted therapies such as bevacizumab (Avastin) and cetuximab (Erbitux), and immunotherapies like pembrolizumab (Keytruda). While these treatments are effective, there is growing interest in dietary modifications to improve gut health and reduce cancer risk. The trial involving canned, pre-cooked beans aims to explore this by enhancing gut microbiota, which is a novel approach not yet reflected in FDA-approved treatments. Current FDA-approved treatments do not specifically include dietary interventions similar to the bean trial.

What other types of research exist?

Promising alternatives to canned, pre-cooked beans for colorectal cancer patients include: 1) Probiotics, which can help modulate gut microbiota and potentially reduce inflammation. 2) Prebiotics, such as germinated barley foodstuff, which have shown anti-tumorigenic effects in animal models. 3) Omega-3 fatty acids, which have been associated with reduced inflammation and maintenance of remission in inflammatory bowel disease. 4) High dietary fiber intake, particularly from fruits, vegetables, and whole grains, which may reduce the risk of colorectal cancer by improving gut health and reducing inflammation.

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Navy Bean Diet for Obesity and Colorectal Cancer Risk

N/A

Waitlist Available

Led By Carrie Daniel-MacDougall, PHD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Adult men and women 30+ years of age

Be older than 18 years old

Must not have

Antibiotic use in the past month and unable/unwilling to be deferred to a later recruitment date

Currently taking exclusionary prescription medications (including cytokines, immunosuppressive agents, chemopreventive drugs, bile acid sequestrants/selective cholesterol absorption inhibitors)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 8

Awards & highlights

No Placebo-Only Group

Summary

This trial studies if eating canned beans regularly can improve gut health and reduce cancer risk in colorectal cancer survivors or those with precancerous polyps and a BMI of 25 or higher. Beans help by boosting healthy bacteria in the digestive system.

Who is the study for?

This trial is for English-speaking adults over 30 in the Houston area who are overweight or obese, with a history of colorectal cancer or precancerous polyps and normal bowel habits post-treatment. Participants must be willing to follow dietary instructions involving beans, provide stool samples, undergo blood draws, and complete web-based dietary assessments.

What is being tested?

The BE GONE Trial aims to determine if consuming canned navy beans can enhance gut microbiome health and mitigate obesity's adverse effects on cancer risk. All participants will either continue their regular diet or add navy beans to their meals for 16 weeks.

What are the potential side effects?

While not explicitly stated, potential side effects may include gastrointestinal discomfort such as bloating or gas due to increased bean consumption.

Eligibility Criteria

Inclusion Criteria

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

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I am 30 years old or older.

Exclusion Criteria

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

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I have taken antibiotics in the last month and cannot delay joining the trial.

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I am not on any drugs that might interfere with the study.

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I regularly take medication for gas, probiotics, or fiber supplements and cannot or do not want to stop for this study.

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I have a genetic form of colorectal cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 8 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Changes in Blood Markers and Metabolites

Changes in Stool 16S rRNA Gene Profiles

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Regular Diet + Beans, Then Regular Diet - BeansExperimental Treatment2 Interventions

Group II: Regular Diet - Beans, Then Regular Diet + BeansActive Control2 Interventions

0 / 5Eligibility 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 dietary modifications, chemotherapy, radiation therapy, and surgical interventions. Dietary modifications, such as increasing fiber intake through foods like canned, pre-cooked beans, aim to improve gut microbiota diversity and reduce inflammation, which can lower cancer risk and improve overall gut health. This is particularly important for colorectal cancer patients as a healthy gut microbiome can enhance immune function and potentially reduce tumor growth. Chemotherapy works by targeting and killing rapidly dividing cancer cells, while radiation therapy uses high-energy rays to destroy cancerous tissues. Surgical interventions involve the removal of cancerous sections of the colon or rectum. These treatments are crucial as they directly target cancer cells, reduce tumor size, and prevent metastasis, thereby improving patient outcomes and survival rates.

Morphological and cell kinetic effects of dietary manipulation during colorectal carcinogenesis.