Rectal Cancer
Conditions
Keywords
stage II, stage III, microbiome, prebiotic, racial disparities
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTSoluble Corn Fiber
once daily additive to diet
DIETARY_SUPPLEMENTMaltodextrin
once daily additive to diet
Sponsors
Ochsner Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years or older 2. Clinical diagnosis of stage 2 or stage 3 rectal cancer 3. Subjects who are women of child-bearing potential must not be pregnant or lactating 4. Have signed an approved informed consent form for the study 5. Be willing to comply with the protocol
Exclusion criteria
1. Patients with a cancer history (excluding the rectal cancer currently being addressed) 2. Allergic to corn or maltodextrin 3. Has, in the Investigator's opinion, any medical condition that makes the subject a poor candidate for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut Flora modulation | 1 year | fiber supplements with prebiotic effects modulate the gut and tumor associated microbiome leading to improved outcomes in stage II and III rectal cancer patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiome changes | 6 months | To characterize the changes in the gut and tumor associated microbiome |
| Immune Profile | 6 months | To evaluate the impact of prebiotic fiber treatment and microbiome changes on the tumor immune profile known to be associated with favorable outcomes |
Countries
United States
Outcome results
None listed