PREBICC: Prebiotic intervention in patients with advanced colorectal cancer treated with 5-FU based chemotherapy: a randomized controlled clinical intervention study

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 62

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,
provided that no systemic antibiotics are used (topical antibiotics are
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

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
- Therapeutic systemic antibiotics used less than one month before the start of
the 5-FU-based treatment (topical antibiotics are 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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoints of this intervention study are the differences (*baseline vs<br /><br>post-intervention) in shifts of overall intestinal microbiota composition,<br /><br>intestinal microbiota diversity, and relative abundance of specific microbial<br /><br>taxa (e.g. Bifidobacterium) between the test group and control group. Based on<br /><br>interventions with prebiotic fibers in other populations published in the<br /><br>literature, and taking the variation seen in the initial analysis of our<br /><br>ongoing observational studies into account, we performed a preliminary power<br /><br>calculation. We expect to enroll a total of 62 patients with advanced<br /><br>colorectal cancer, 31 patients in the test group and 31 patients in the control<br /><br>group. This sample size is deemed necessary to ensure sufficient statistical<br /><br>power to observe the effects of the prebiotic fibers.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>As exploratory objectives, this study will assess: (1) The feasibility,<br /><br>tolerance, and compliance of a nutritional intervention with a prebiotic ONS in<br /><br>patients with advanced CRC, (2) the effects of the prebiotic ONS on fecal and<br /><br>blood parameters, tumor response, chemotherapy toxicity as well as the<br /><br>metabolic phenotype (e.g. body weight, body composition, inflammatory profile),<br /><br>and (3) the consequences for the patient-reported QoL and physical functioning<br /><br>compared to a control ONS. </p><br>