Prebiotics in Rectal Cancer

Study Overview
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Brief Summary
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A significant racial disparity in the incidence and mortality of CRC exists in the U.S. with African Americans having CRC incidence and mortality rates that are 20% and 40% higher than the general U.S. population. It has been demonstrated that the gut microbiome impacts tumor development and progression through multiple mechanisms, including impacting the tumoral immune response. However, it is unknown if microbiome modulating treatment can have an impact on CRC outcomes.

Detailed Description
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A significant racial disparity in the incidence and mortality of CRC exists in the U.S. with African Americans having CRC incidence and mortality rates that are 20% and 40% higher than the general U.S. population. It has been demonstrated that the gut microbiome impacts tumor development and progression through multiple mechanisms, including impacting the tumoral immune response. However, it is unknown if microbiome modulating treatment can have an impact on CRC outcomes. This is a pilot project to see if any changes are detected in stool and/or tissue samples in rectal cancer patients who receive a soluble corn fiber supplement during their neoadjuvant treatment.

Official Title
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Do Prebiotics Change Intestinal Biome in Rectal Cancer Patients Undergoing Neoadjuvant Therapy

Conditions
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Rectal Cancer

Intervention / Treatment
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* Dietary Supplement: Soluble Corn Fiber
* Dietary Supplement: Maltodextrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years or older Clinical diagnosis of stage 2 or stage 3 rectal cancer Subjects who are women of child-bearing potential must not be pregnant or lactating Have signed an approved informed consent form for the study Be willing to comply with the protocol Exclusion Criteria: Patients with a cancer history (excluding the rectal cancer currently being addressed) Allergic to corn or maltodextrin Has, in the Investigator's opinion, any medical condition that makes the subject a poor candidate for the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prebiotic<br>Soluble Corn Fiber | Dietary Supplement: Soluble Corn Fiber<br>* once daily additive to diet<br>|
| Placebo Comparator: Control<br>Maltodextrin | Dietary Supplement: Maltodextrin<br>* once daily additive to diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut Flora modulation | fiber supplements with prebiotic effects modulate the gut and tumor associated microbiome leading to improved outcomes in stage II and III rectal cancer patients | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome changes | To characterize the changes in the gut and tumor associated microbiome | 6 months | 
| Immune Profile | To evaluate the impact of prebiotic fiber treatment and microbiome changes on the tumor immune profile known to be associated with favorable outcomes | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II, stage III, microbiome, prebiotic, racial disparities