Colorectal cancer Colon cancer
Conditions
Interventions
Patients will be stratified based on their assigned chemotherapy regimen before
randomization (FOLFOX, CAPOX, and CAP). Following stratification, patients will
undergo a 1:1 block randomization. Pat
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, a subject must meet all of the following criteria: - Patients diagnosed with advanced CRC who will be treated with 5-FU-based therapy (FOLFOX, CAPOX, capecitabine monotherapy) - Simultaneous treatment with bevacizumab, panitumumab or cetuximab is allowed. - Proficient use of the Dutch language - The patient is older than 18 years of age - Performance (ECOG/WHO) score 0-2 - Written informed consent
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Microsatellite instability (MSI) or deficient mismatch repair (MMR) proteins - Abnormal DPYD and/or reduced DPD enzyme function - Presence of ileostomy - Pregnant or nursing - Previous systemic therapy for advanced CRC. If the patient received prior (neo)adjuvant systemic therapy, it must have been completed at least 6 months before the diagnosis of the advanced disease - Use of therapeutic systemic antibiotics within four weeks prior to the start of the study. However, systemic antibiotics prescribed as part of prophylactic or protocolized management of EGFR-inhibitor-related toxicities (e.g., skin toxicity) are permitted. All other prophylactic and topical antibiotics are also allowed. - Abdominal radiotherapy less than two weeks before the start of the 5-FU-based therapy - Simultaneous use of other pro- and/or prebiotics during the study period (see the example list in appendix E in *E1 E2. Informatiebrief en toestemmingsformulier proefpersonen*) - Inflammatory bowel disease (Crohn's disease or ulcerative colitis) - Simultaneous treatment with irinotecan-based therapy - Known allergy to any ingredients present in the test or control ONS, requiring a fibre-free diet or suffering galactosemia or lactose intolerance - Simultaneous participation in another medical-scientific intervention study - Physically or mentally incapable or incompetent - All conditions that, in the opinion of the physician, are not suitable for participation in this study (e.g. severe renal failure).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoints of this intervention study are the differences (*baseline vs post-intervention) in shifts of overall intestinal microbiota composition, intestinal microbiota diversity, and relative abundance of specific microbial taxa (e.g. Bifidobacterium) between the test group and control group. Based on interventions with prebiotic fibers in other populations published in the literature, and taking the variation seen in the initial analysis of our ongoing observational studies into account, we performed a preliminary power calculation. We expect to enroll a total of 62 patients with advanced colorectal cancer, 31 patients in the test group and 31 patients in the control group. This sample size is deemed necessary to ensure sufficient statistical power to observe the effects of the prebiotic fibers. | — |
Secondary
| Measure | Time frame |
|---|---|
| As exploratory objectives, this study will assess: (1) The feasibility, tolerance, and compliance of a nutritional intervention with a prebiotic ONS in patients with advanced CRC, (2) the effects of the prebiotic ONS on fecal and blood parameters, tumor response, chemotherapy toxicity as well as the metabolic phenotype (e.g. body weight, body composition, inflammatory profile), and (3) the consequences for the patient-reported QoL and physical functioning compared to a control ONS. | — |
Countries
Netherlands
Contacts
Public ContactM.A.M. Stevens
Universiteit Maastricht
Outcome results
None listed