Bacterial Intestinal Gut Modification Around Cancer Surgery (BIG MACS) Diet for Patients with Colon Cancer Undergoing Surgery

Status: complete

This study tests how well the Bacterial Intestinal Gut Modification Around Cancer Surgery (BIG MACS) diet works in supporting the microbiome and improving outcomes for patients with colon cancer undergoing surgery. The BIG MACS diet encourages an increase of foods such as vegetables, legumes, whole grains and fermented foods in order to build a healthy gut microbiome. The gut microbiome is the community of bacterial, fungi, and archaea, and their genetic content that inhabit the human gastrointestinal tract. This may influence post-surgical complications and nutrition. In addition to assessing the feasibility and tolerability of the BIG MACS diet during the surgical treatment period, this study will preliminarily evaluate the impact of the diet using markers of muscle quantity and quality as biomarkers for nutritional status as predictors of outcome after cancer surgery. Biomarker is defined as a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. Following the BIG MACS diet before and after surgery may improve outcomes for patients with colon cancer undergoing surgery.

Inclusion Criteria

Age 25-70 years
Primary diagnosis of colon cancer, stages 1-3
Able and willing to provide informed consent
English-speaking
Willingness to return to the study site for specified study visits at day (D)7 and D30
Able to comply with study measures

Exclusion Criteria

Age =< 25 years or >= 70 years
If surgery is being performed for any reason other than resection of colon cancer
Neoadjuvant therapy, or if surgery is not the initial approach for the patient’s colon cancer treatment
Significant anemia (hemoglobin 1.0 g/dL or more below normal range) or history of coagulopathy: Any personal history of hereditary or acquired bleeding disorder, or thrombocytopenia with platelets under 100,000
Serum creatinine greater than 1.5 mg/dL
Serum total bilirubin greater than the upper limit of normal in the absence of Gilbert’s syndrome
Alkaline phosphatase or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the upper limit of normal
Elevated international normalized ration (INR) (1.5 or above)
Alcohol intake more than one drink or greater than 20 grams per day for women or 30 grams per day for men
History of gastrointestinal surgery including stomach, small bowel or colon resection, pancreatic surgery, bile duct or gallbladder surgery splenectomy, or gastric bypass
History of intra-abdominal sepsis
Previous organ transplantation
Self-reported human immunodeficiency virus (HIV)-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease
Currently pregnant or nursing
History of alcohol, drug, or opioid dependency (excluding nicotine) in the past five years
Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol
Depression: A Center for Epidemiologic Studies depression scale (CES-D) score more than 16 and a psychologist determining that the patient is not a good fit for surgery
Body mass index (BMI) <20 or > 40 kilograms per meter squared: obesity is known to impact the microbiome and immune system and the occurrence of anastomotic leak, and extreme obesity may confound interpretation of these factors in association to leak. Inferences may be made by matching participants with less severe obesity (BMI <40)
Presence of any type of non-MRI compatible implant, including cardiac pacemakers or defibrillators, neurostimulators, cochlear implants, or other metallic hardware
Self-reported history of claustrophobia
Incarceration
Inability to adhere to the study protocol, procedures, and diet
Exclusions may also be made at the discretion of the attending physician

PRIMARY OBJECTIVES:

I. To characterize the relationship between muscle wasting and the microbiome in a control cohort receiving current standard of care.

IIa. To establish the feasibility of implementing the BIG MACS diet in an experimental cohort.

IIb. Preliminarily compare muscle wasting in the control cohort against the experimental cohort.

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP I: Patients consume a traditional healthy diet and 1 protein shake a day for 4 weeks prior to surgery. Patients then undergo surgery. Patients then are asked to reintroduce foods following the advice of their surgical team and to eat normally as tolerated.

GROUP II: Patients consume the BIG MACS diet and 1 protein shake a day for 4 weeks prior to surgery. Patients then undergo surgery. Patients then follow the BIG MACS diet for 4 weeks after surgery, with solid food reintroduction after surgery as early as tolerated.

Patients undergo blood and fecal sample collection and magnetic resonance imaging (MRI) while on study.

Have a question?
We're here to help

Chat with us: LiveHelp
Call us: 1-800-4-CANCER
(1-800-422-6237)

Which trials are right for you?

Use the checklist in our guide to gather the information you’ll need.

Bacterial Intestinal Gut Modification Around Cancer Surgery (BIG MACS) Diet for Patients with Colon Cancer Undergoing Surgery

Description

Eligibility Criteria

Locations & Contacts

Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

Have a question?We're here to help

Which trials are right for you?

Have a question?
We're here to help